This document provides a summary of experience and qualifications for Mary Koppe-Dixon, RN. She has over 25 years of experience as a clinical research associate monitoring Phase I-IV trials across many therapeutic areas, including asthma, cardiology, neurology, and psychiatry. She is proficient in clinical trial management systems and has experience working with various electronic data capture systems. She holds a nursing license in Missouri and has managed clinical trial sites and coordinated clinical research operations.
Nurse Staffing And Quality Of Careللطالب عامر آل الريTsega Tilahun
This document discusses a study on the relationship between nurse staffing levels and quality of patient care. The study will be conducted at King Khaled Hospital University in Riyadh, Saudi Arabia, surveying 1,300 nurses. Previous research has found mixed results on the impact of nurse staffing levels, with some studies finding higher nurse levels associated with better outcomes. The methodology will use a descriptive correlational design to collect daily staffing data and patient outcomes over time to analyze the relationship between staffing levels and quality indicators.
MEDICAL AUDIT
Evaluation of data, documents, and resources to check performance of systems meets specified standards
PRESCRIPTION MONITORING, ADR, DRUG RELATED PROBLEMS, staff safety, data,defining standards,
collecting data,
identifying areas for improvement,
making necessary changes
back round to defining new standards.
Journal Club: Current Thoughts for The Prevention & Treatment of Pressure UlcersMeeran Earfan
1. The document reviewed evidence on various modalities for preventing and treating pressure ulcers. It found that specialized mattresses, wound cleansers containing aloe/silver chloride/decyl glucoside, vitamin C supplementation, honey dressings, and nutritional optimization can help with prevention and healing, while evidence is unclear for other modalities like repositioning, debridement methods, and ultrasound therapy.
2. The authors' treatment protocol involves specialized air mattresses, nutritional support including vitamin C, frequent repositioning, and wound cleaning or sharp debridement depending on ulcer severity, potentially followed by fasciocutaneous flaps.
3. The review concluded that the evidence demonstrates the effectiveness of some
The final protocol (v5.3). Notable changes include:
1) Confirmation of audit standard (Page 6).
2) Refinement of inclusion and exclusion criteria (Page 7)
3) Confirmation of audit status (Appendix C)
4) Refinement of required data fields (Page 19) including definitions (Pages 20-25)
Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, a...OARSI
The document discusses considerations for developing medical products to treat osteoarthritis (OA) using structural endpoints. It notes that while modifying disease pathophysiology and changing the natural course of OA is desirable, there are challenges to reliably assessing a product's ability to alter disease progression. Specifically, there is a lack of standard definitions for progression and validated endpoints. Additionally, the relationship between structural changes and symptoms/function is variable. The document advises that substantial evidence would be needed to accept a structural endpoint for accelerated approval and reliably predict clinical benefits like reduced pain and increased function. The ultimate goal is to avoid joint failure and replacement while preserving function and relieving pain.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
Nurse Staffing And Quality Of Careللطالب عامر آل الريTsega Tilahun
This document discusses a study on the relationship between nurse staffing levels and quality of patient care. The study will be conducted at King Khaled Hospital University in Riyadh, Saudi Arabia, surveying 1,300 nurses. Previous research has found mixed results on the impact of nurse staffing levels, with some studies finding higher nurse levels associated with better outcomes. The methodology will use a descriptive correlational design to collect daily staffing data and patient outcomes over time to analyze the relationship between staffing levels and quality indicators.
MEDICAL AUDIT
Evaluation of data, documents, and resources to check performance of systems meets specified standards
PRESCRIPTION MONITORING, ADR, DRUG RELATED PROBLEMS, staff safety, data,defining standards,
collecting data,
identifying areas for improvement,
making necessary changes
back round to defining new standards.
Journal Club: Current Thoughts for The Prevention & Treatment of Pressure UlcersMeeran Earfan
1. The document reviewed evidence on various modalities for preventing and treating pressure ulcers. It found that specialized mattresses, wound cleansers containing aloe/silver chloride/decyl glucoside, vitamin C supplementation, honey dressings, and nutritional optimization can help with prevention and healing, while evidence is unclear for other modalities like repositioning, debridement methods, and ultrasound therapy.
2. The authors' treatment protocol involves specialized air mattresses, nutritional support including vitamin C, frequent repositioning, and wound cleaning or sharp debridement depending on ulcer severity, potentially followed by fasciocutaneous flaps.
3. The review concluded that the evidence demonstrates the effectiveness of some
The final protocol (v5.3). Notable changes include:
1) Confirmation of audit standard (Page 6).
2) Refinement of inclusion and exclusion criteria (Page 7)
3) Confirmation of audit status (Appendix C)
4) Refinement of required data fields (Page 19) including definitions (Pages 20-25)
Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, a...OARSI
The document discusses considerations for developing medical products to treat osteoarthritis (OA) using structural endpoints. It notes that while modifying disease pathophysiology and changing the natural course of OA is desirable, there are challenges to reliably assessing a product's ability to alter disease progression. Specifically, there is a lack of standard definitions for progression and validated endpoints. Additionally, the relationship between structural changes and symptoms/function is variable. The document advises that substantial evidence would be needed to accept a structural endpoint for accelerated approval and reliably predict clinical benefits like reduced pain and increased function. The ultimate goal is to avoid joint failure and replacement while preserving function and relieving pain.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
The document discusses Good Clinical Practices (GCP), which are international ethical and scientific quality standards for clinical research involving human subjects. It outlines the goals and foundations of GCP, including protecting subjects' rights and safety, ensuring quality data collection, and providing guidelines for clinical research conduct. The key principles discussed are from the Nuremberg Code, Declaration of Helsinki, Belmont Report, ICH-GCP guidelines, and ISO 14155. Compliance with GCP provides assurance that clinical trials are properly designed, monitored, recorded and reported to protect subject welfare and ensure results credibility.
A full proof presentation on Clinical Trials and its Phases. This presentation contains clear description of clinical trials and its phases with suitable examples. All key points have been tried to be covered. After going through this presentation, one should be able to discuss about clinical trials and its phases.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
Importance of Medical Audit
Don't let COVID - 19 impact your practice. Get Free Practice Analysis and be financially healthy. Call Now - 888-357-3226
Click Here For More Information: https://bit.ly/3kw4rka
Get a Free Quote: https://bit.ly/30DFr2z
#texasmedicalbillingandcodingservices #medicalbillingauditing #medicare #medicalbillingandcoding #MBC #importanceofmedicalaudit #medicalaudit #medicalbillingguideline
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
Source: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Phase 0 & i clinical trial designing,conduct &challengesDrSatyabrataSahoo
This document discusses clinical trial phases, with a focus on Phase 0 and Phase 1 trials. It provides background on clinical trials and their history. Phase 0 trials involve microdosing to obtain early human pharmacokinetic and pharmacodynamic data before Phase 1. Phase 1 trials determine the maximum tolerated dose and safety profile of a new drug. Both phases present challenges, such as developing sensitive biomarker assays for Phase 0 and managing costs and duration for Phase 1 trials. Overall, clinical trials are essential for advancing new medical treatments.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Audit and stat for medical professionalsNadir Mehmood
This document discusses clinical audit and statistics. It begins by defining audit and its importance in clinical practice. The document outlines the types of audit and how statistics are used in clinical practice. It discusses the components of a clinical audit and defines key statistical terms like population, sample, and descriptive statistics. The document provides examples to illustrate statistical concepts and calculations like descriptive statistics and the area under the curve of a normal distribution. It emphasizes that the goal of statistics is to summarize data in a way that is understandable for non-statisticians.
The document provides an overview of the clinical trial process for new drugs. It discusses the various phases of clinical trials including preclinical testing in animals, Phase 0 microdosing studies, Phase I safety trials in healthy volunteers, Phase II small efficacy trials in patients, and Phase III large randomized controlled trials to confirm efficacy. The goal of clinical trials is to systematically evaluate a new drug's safety and efficacy in humans at various dose levels before it can be approved for marketing. Each phase addresses different objectives and increases in size and scope as the trials progress from preclinical to final approval stages.
This clinical trial protocol summarizes a phase 2 double-blind randomized placebo-controlled trial to evaluate the safety and efficacy of TJ301 for the treatment of active ulcerative colitis. The trial will enroll 90 patients to receive either 600mg of TJ301 biweekly, 300mg of TJ301 biweekly, or placebo biweekly for 12 weeks. The primary endpoint is clinical and endoscopic remission at week 12. Secondary endpoints include safety assessments, pharmacokinetic measures, and changes in disease activity scores from baseline to week 12. The protocol outlines the study design, patient selection criteria, treatments, assessments, data management, and statistical analysis plan.
The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
Hand book of good clinical research practicePTCnetwork
This document provides an introduction and overview of Good Clinical Practice (GCP) guidelines. GCP provides standards for clinical research involving human subjects to ensure ethical and scientific quality. Compliance with GCP protects subjects' rights and safety while ensuring research integrity. GCP responsibilities are shared by all involved parties. The guidelines aim to help national authorities, sponsors, investigators and ethics committees properly implement GCP for clinical trials.
Guidelines and Format on Case Presentation and Discussion - ROJosonReynaldo Joson
This document provides guidelines for presenting and discussing a clinical case. It outlines the specific format and sections to include: case presentation with patient data and history; clinical diagnosis with primary and secondary diagnoses; paraclinical diagnostic procedures and test selection; treatment plan; and prevention and health promotion advice. The case presentation and discussion should clearly present the clinical reasoning process and management of an actual patient case within the specified format.
The document discusses the application of evidence-based nursing to support patient safety goals. It outlines six main patient safety goals: 1) correct patient identification, 2) improved communication effectiveness, 3) improved safety of high-alert medications, 4) ensuring correct-site, correct-procedure, correct-patient surgery, 5) reducing health care-associated infections, and 6) reducing patient harm from falls. For each goal, it provides evidence-based strategies nurses can implement, such as using patient identification bracelets, conducting time outs before procedures, and emphasizing hand hygiene to prevent infections. Overall, the document advocates applying best evidence from resources like the WHO to design, implement, and evaluate changes to nursing practice that enhance patient safety
This document outlines the phases of clinical drug trials. It discusses the objectives and methods of each phase. Phase I trials test drug safety in healthy volunteers. Phase II trials test efficacy and side effects in patients to determine dosage. Phase III trials test efficacy and safety in large randomized controlled trials. Phase IV trials monitor drug use after marketing to detect rare or long-term effects. Each phase uses different doses, patients, investigators, and sample sizes to progressively evaluate a drug's safety and effectiveness in humans. The overall goal is to translate preclinical animal findings into cautious human testing.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.
Declaration of helsinki powerpoint presentationPoojaGupta767
The document summarizes the history and key principles of the Declaration of Helsinki, which establishes ethical guidelines for medical research involving human subjects. It originated in 1964 and has undergone several revisions. The Declaration's goals are to protect research participants and ensure research is justified. Some key principles are that research must have scientific merit and potential benefits outweigh risks, participants must provide informed consent, and special protections apply to biomedical research combined with patient care.
The document outlines a program in clinical trials, research, and data management consisting of 7 modules. Module I discusses clinical trials and the clinical trials environment. Module II covers statistics for clinical trials. Module III is about clinical data management. Module IV is on contract research. Module V addresses regulatory affairs, good clinical practices, pharmacovigilance, and ethics. Module VI is on practical medical writing and documentation. Module VII provides skills for conducting research studies. The program aims to provide skills for careers in clinical research.
Dynika St Omer has over 5 years of experience as a clinical research coordinator and medical laboratory technician. She currently works as a clinical research coordinator for the Obstetrical Maternal Newborn Investigations research group at the Ottawa Hospital Research Institute. She oversees multiple clinical trials and studies at two Ontario sites. Her responsibilities include participant recruitment, obtaining consent, data collection, sample collection and processing, regulatory documentation, and study coordination. She has experience coordinating trials in dermatology and obstetrics/maternal health. Dynika strives to maintain high professional standards through continuing education and certifications in good clinical practice and research ethics.
Carlos Martinez has over 25 years of experience in clinical research, having worked as a clinical research consultant, clinical research associate, project administrator, and clinical research coordinator on various Phase I-IV clinical trials. His experience includes monitoring trials, ensuring regulatory compliance, resolving issues, maintaining relationships with investigators, and verifying drug accountability. He has extensive skills in computer systems used in clinical research and holds a degree in Biology from the University of Texas at Austin.
The document discusses Good Clinical Practices (GCP), which are international ethical and scientific quality standards for clinical research involving human subjects. It outlines the goals and foundations of GCP, including protecting subjects' rights and safety, ensuring quality data collection, and providing guidelines for clinical research conduct. The key principles discussed are from the Nuremberg Code, Declaration of Helsinki, Belmont Report, ICH-GCP guidelines, and ISO 14155. Compliance with GCP provides assurance that clinical trials are properly designed, monitored, recorded and reported to protect subject welfare and ensure results credibility.
A full proof presentation on Clinical Trials and its Phases. This presentation contains clear description of clinical trials and its phases with suitable examples. All key points have been tried to be covered. After going through this presentation, one should be able to discuss about clinical trials and its phases.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
Importance of Medical Audit
Don't let COVID - 19 impact your practice. Get Free Practice Analysis and be financially healthy. Call Now - 888-357-3226
Click Here For More Information: https://bit.ly/3kw4rka
Get a Free Quote: https://bit.ly/30DFr2z
#texasmedicalbillingandcodingservices #medicalbillingauditing #medicare #medicalbillingandcoding #MBC #importanceofmedicalaudit #medicalaudit #medicalbillingguideline
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
Source: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Phase 0 & i clinical trial designing,conduct &challengesDrSatyabrataSahoo
This document discusses clinical trial phases, with a focus on Phase 0 and Phase 1 trials. It provides background on clinical trials and their history. Phase 0 trials involve microdosing to obtain early human pharmacokinetic and pharmacodynamic data before Phase 1. Phase 1 trials determine the maximum tolerated dose and safety profile of a new drug. Both phases present challenges, such as developing sensitive biomarker assays for Phase 0 and managing costs and duration for Phase 1 trials. Overall, clinical trials are essential for advancing new medical treatments.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Audit and stat for medical professionalsNadir Mehmood
This document discusses clinical audit and statistics. It begins by defining audit and its importance in clinical practice. The document outlines the types of audit and how statistics are used in clinical practice. It discusses the components of a clinical audit and defines key statistical terms like population, sample, and descriptive statistics. The document provides examples to illustrate statistical concepts and calculations like descriptive statistics and the area under the curve of a normal distribution. It emphasizes that the goal of statistics is to summarize data in a way that is understandable for non-statisticians.
The document provides an overview of the clinical trial process for new drugs. It discusses the various phases of clinical trials including preclinical testing in animals, Phase 0 microdosing studies, Phase I safety trials in healthy volunteers, Phase II small efficacy trials in patients, and Phase III large randomized controlled trials to confirm efficacy. The goal of clinical trials is to systematically evaluate a new drug's safety and efficacy in humans at various dose levels before it can be approved for marketing. Each phase addresses different objectives and increases in size and scope as the trials progress from preclinical to final approval stages.
This clinical trial protocol summarizes a phase 2 double-blind randomized placebo-controlled trial to evaluate the safety and efficacy of TJ301 for the treatment of active ulcerative colitis. The trial will enroll 90 patients to receive either 600mg of TJ301 biweekly, 300mg of TJ301 biweekly, or placebo biweekly for 12 weeks. The primary endpoint is clinical and endoscopic remission at week 12. Secondary endpoints include safety assessments, pharmacokinetic measures, and changes in disease activity scores from baseline to week 12. The protocol outlines the study design, patient selection criteria, treatments, assessments, data management, and statistical analysis plan.
The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
Hand book of good clinical research practicePTCnetwork
This document provides an introduction and overview of Good Clinical Practice (GCP) guidelines. GCP provides standards for clinical research involving human subjects to ensure ethical and scientific quality. Compliance with GCP protects subjects' rights and safety while ensuring research integrity. GCP responsibilities are shared by all involved parties. The guidelines aim to help national authorities, sponsors, investigators and ethics committees properly implement GCP for clinical trials.
Guidelines and Format on Case Presentation and Discussion - ROJosonReynaldo Joson
This document provides guidelines for presenting and discussing a clinical case. It outlines the specific format and sections to include: case presentation with patient data and history; clinical diagnosis with primary and secondary diagnoses; paraclinical diagnostic procedures and test selection; treatment plan; and prevention and health promotion advice. The case presentation and discussion should clearly present the clinical reasoning process and management of an actual patient case within the specified format.
The document discusses the application of evidence-based nursing to support patient safety goals. It outlines six main patient safety goals: 1) correct patient identification, 2) improved communication effectiveness, 3) improved safety of high-alert medications, 4) ensuring correct-site, correct-procedure, correct-patient surgery, 5) reducing health care-associated infections, and 6) reducing patient harm from falls. For each goal, it provides evidence-based strategies nurses can implement, such as using patient identification bracelets, conducting time outs before procedures, and emphasizing hand hygiene to prevent infections. Overall, the document advocates applying best evidence from resources like the WHO to design, implement, and evaluate changes to nursing practice that enhance patient safety
This document outlines the phases of clinical drug trials. It discusses the objectives and methods of each phase. Phase I trials test drug safety in healthy volunteers. Phase II trials test efficacy and side effects in patients to determine dosage. Phase III trials test efficacy and safety in large randomized controlled trials. Phase IV trials monitor drug use after marketing to detect rare or long-term effects. Each phase uses different doses, patients, investigators, and sample sizes to progressively evaluate a drug's safety and effectiveness in humans. The overall goal is to translate preclinical animal findings into cautious human testing.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.
Declaration of helsinki powerpoint presentationPoojaGupta767
The document summarizes the history and key principles of the Declaration of Helsinki, which establishes ethical guidelines for medical research involving human subjects. It originated in 1964 and has undergone several revisions. The Declaration's goals are to protect research participants and ensure research is justified. Some key principles are that research must have scientific merit and potential benefits outweigh risks, participants must provide informed consent, and special protections apply to biomedical research combined with patient care.
The document outlines a program in clinical trials, research, and data management consisting of 7 modules. Module I discusses clinical trials and the clinical trials environment. Module II covers statistics for clinical trials. Module III is about clinical data management. Module IV is on contract research. Module V addresses regulatory affairs, good clinical practices, pharmacovigilance, and ethics. Module VI is on practical medical writing and documentation. Module VII provides skills for conducting research studies. The program aims to provide skills for careers in clinical research.
Dynika St Omer has over 5 years of experience as a clinical research coordinator and medical laboratory technician. She currently works as a clinical research coordinator for the Obstetrical Maternal Newborn Investigations research group at the Ottawa Hospital Research Institute. She oversees multiple clinical trials and studies at two Ontario sites. Her responsibilities include participant recruitment, obtaining consent, data collection, sample collection and processing, regulatory documentation, and study coordination. She has experience coordinating trials in dermatology and obstetrics/maternal health. Dynika strives to maintain high professional standards through continuing education and certifications in good clinical practice and research ethics.
Carlos Martinez has over 25 years of experience in clinical research, having worked as a clinical research consultant, clinical research associate, project administrator, and clinical research coordinator on various Phase I-IV clinical trials. His experience includes monitoring trials, ensuring regulatory compliance, resolving issues, maintaining relationships with investigators, and verifying drug accountability. He has extensive skills in computer systems used in clinical research and holds a degree in Biology from the University of Texas at Austin.
Vilma Mejia has over 25 years of experience in clinical trials as a research professional. She has worked in roles such as clinical research coordinator, monitor, associate clinical trials manager, and project manager. She has managed multi-million dollar, global clinical trials in various therapeutic areas, including cardiology, neurology, and psychiatry. Currently, she is a Clinical Trials Manager at Mount Sinai Hospital, where she oversees regulatory documents, data collection, quality assurance, finances, and staff for cardiology research studies.
Wendy Johnson has over 12 years of experience in clinical laboratories and as a medical laboratory technologist. She has a Bachelor's degree in Biology from the University of North Carolina at Greensboro and a Master's degree in Health Administration from Pfeiffer University. Currently, she works as a Clinical Research Associate coordinating clinical studies for Roche Diagnostics, ensuring studies adhere to regulations and meet objectives. Previously she has worked performing cancer diagnostic testing, newborn genetic screening tests, and specimen processing.
Mary Pat McKee has over 30 years of experience as a registered dietitian. She is currently a PRN dietitian at Cincinnati Children's Hospital Medical Center. Previously she was the clinical nutrition manager at Cincinnati Children's Hospital Medical Center for 10 years. She has a Master's degree in Epidemiology from the University of Cincinnati and a Bachelor's degree from the University of Dayton. She has published articles and presented at numerous conferences on topics related to clinical nutrition and research.
Updated Emily Curriculum Vitae 2016CRAEmily Pierce
Emily Pierce is a registered nurse with over 10 years of experience in oncology clinical research. She currently works as a Clinical Research Nurse/Coordinator at the James P. Wilmot Cancer Center, where she oversees multiple phase 1-3 oncology clinical trials. She has extensive experience in all aspects of clinical trial management including protocol development, regulatory compliance, patient enrollment, data collection and reporting. She also serves on several committees related to clinical research and nursing.
Anuj Kumar is a clinical research professional currently working as a Site Solutions Executive. He has over 5 years of experience working as a Clinical Research Coordinator on various clinical trials. His experience includes coordinating trial activities, ensuring protocol compliance, informed consent processes, data entry, maintaining documentation, and supporting site monitoring visits. He holds an Advanced Diploma in Clinical Research and degrees in Microbiology and Science. He is proficient in computer programs for clinical research and has participated in various clinical research training programs and workshops.
This document is a resume for Apryl J. Dixon that summarizes her professional experience and qualifications. She has over 10 years of experience as a respiratory therapist in critical care units. She also has experience conducting medical research and working as a medical office assistant. Her education includes a bachelor's degree in health and human sciences with a focus on respiratory therapy.
Erin Perez is a registered nurse with over 10 years of experience in nursing, quality improvement, and scientific research. She currently works as a float pool nurse at Washington Hospital, where she assists with various quality improvement projects. Previously, she has held roles conducting health education and vaccinations, implementing an MRSA testing protocol, and developing analytical methods in biochemistry research labs. Perez received her MSN in Clinical Nurse Leadership from the University of San Francisco and has relevant experience, skills and certifications in nursing, research, and quality improvement.
Rabica Shahid has over 6 years of experience as a clinical research coordinator. She holds an MD from Windsor University School of Medicine and an advanced diploma in biotechnology from Centennial College. Her experience includes coordinating clinical trials, scheduling participants, reviewing protocols, obtaining informed consent, and ensuring compliance. She is proficient in EMR systems and has experience in various clinical settings including family medicine, internal medicine, OB/GYN, and others. Her future goals are to provide compassionate care using her skills and knowledge, cultivate leadership in her field, and continue expanding her knowledge through research.
Rabica Shahid has over 6 years of experience as a clinical research coordinator. She holds an MD from Windsor University School of Medicine and an advanced diploma in biotechnology from Centennial College. Her experience includes coordinating clinical trials, scheduling participants, reviewing protocols, obtaining informed consent, and ensuring compliance. She is proficient in EMR systems and has experience in various clinical settings including family medicine, internal medicine, OB/GYN, and others. Her future goals are to provide compassionate care using her skills and knowledge, cultivate leadership in her field, and continue expanding her knowledge through research.
This document is a curriculum vitae for Dr. Shanea Parker that outlines her education and professional experience. She received her Doctor of Pharmacy degree from Hampton University in 2004 and has since held various pharmacy positions including manager, clinical pharmacist, and assistant professor. Her experience ranges from hospital, retail, and academic settings. She is licensed and certified in Virginia and maintains active involvement in professional organizations.
Dr. Nancy Louis Wassef has over 30 years of experience in clinical pathology and laboratory management. She has held leadership roles as the Head of Pathology Departments and Laboratories in the UK, Saudi Arabia, and Europe. Her expertise includes clinical chemistry, hematology, microbiology, and transfusion medicine. She has published over 30 medical papers and is fluent in English, French, and Arabic.
Sometimes practical or ethical considerations dictate whether healthy volunteers or patients should be recruited for a particular study. But there are usually sound scientific arguments for collecting PK data from actual patients, to supplement or substitute for PK data obtained from human healthy volunteers during the first phases of drug development. Knowing to what extent the results obtained in healthy volunteers – if available - can be extrapolated to the intended treatment population is critical. The US FDA has recognized the importance of PK studies for determining drug concentration-time profiles in target patient populations.
The candidate has over 7 years of experience as a research coordinator managing clinical trials and research studies in mood disorders. They lead a team and are responsible for all aspects of clinical trial operations including regulatory documentation, patient recruitment, data collection, budget management, and training staff. The candidate seeks a clinical research associate position to utilize their skills developing and leading research clinics.
Evidence based practice aims to integrate the best research evidence with clinical expertise and patient values. It involves 5 steps: formulating a question, finding evidence, critically appraising evidence, applying evidence to a patient, and evaluating outcomes. Key resources for finding evidence include pre-appraised sources like UpToDate and filtered databases like PubMed. Models like the Stelter and Iowa models provide guidelines for implementing evidence-based projects. The goal of evidence based practice is to provide the highest quality care based on the best available research.
Objective: To evaluate the utility of a targeted lecture in improving FP awareness amongst clinicians.
Design: This is a dual institution, prospective survey-based study assessing if an educational lecture can increase the likelihood of FP consideration, discussion, and referral.
Clinical Trials Are Medically Based ExperimentsRachel Phillips
Clinical trials are medically based experiments undertaken on human subjects to systematically determine the effectiveness and/or safety of therapeutic interventions. They are created to measure things like determining if a treatment is more effective than a placebo or if one treatment is more effective than another. Clinical trials must comply with various guidelines and regulations to protect human subjects, ensure safety, and create an environment favorable for conducting research with the highest standards of patient safety.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
M koppe dixon-cv.2016
1. Mary Koppe-Dixon, RN
Senior Clinical Research Associate
Meredith King Clinical Research Consulting
12665 NW 126th
Court
Platte City, MO 816-739-2624
SUMMARY OF EXPERIENCE
Phase I – IV Experience in Monitoring the following: Adult /Pediatric Asthma and Allergy (Including device
delivery systems), Cardiology, Cardiac and Carotid Stents, Cardiac Device, Orthopedic Device,
Hypertension, Dyslipidemia, Dermatology, Tinea Pedis, Tinea Cruis, Vaginal Candidiasis, Bacterial
Vaginosis, Skin Infections, Hepatitis B, Renal Dialysis, Urology/Renal Disease, Oncology (Phase 1),
Parkinson’s Disease, Multiple Sclerosis, Alzheimer’s, Dementia, Lupus, Rheumatoid Arthritis, Epilepsy,
Diabetes, Migraine, Stroke, Depression, Schizophrenia, Insomnia, GERD, Ulcerative Colitis, H-pylori,
Chronic Constipation, Crohn’s Disease, Pediatric/Adult Ophthalmology (Infection, Macular Edema,
Glaucoma, AMD, Retinal Disease, Allergic Conjunctivitis), and Infant Nutrition. I have worked with Inform,
Phoenix Data Systems, Impact, MediData/Rave, Oracle, eClinicalOs, and other EDC systems. I am
proficient in CTMS, Microsoft Word, Excel, and Power Point software.
EDUCATION Oak Park Senior High School, Kansas City, MO
Research College of Nursing, Kansas City, MO
UMKC Bloch School of Business, Kansas City, MO
LICENSES Registered Nurse in State of Missouri 087891
SUMMARY OF POSITIONS
Alcresta Pharmaceuticals September 2015 to Present
Hospira September to December 2015
NCGS December 2013 to June 2015
Pfizer January 2014 to October 2014
Rockwell Medical May 2013 to December 2013
MMG August 2013 to December 2013
WCT SR CRA June 2012 to June 2013
Contract SR CRA Covance Inc. March 2012 to June 2012
Contract CRA PRA July 2011 to March 2012
Page 1 of 16
2. Contract /Lead CRA Ingenix //SuperGen/Regeneron October 2009 – March 2012
Contract CRA, DCRI August 2007- July 2011
Contract CRA, Novo Nordisk December 2007 - June 2008
Contract Lead CRA Pharmasset June 2008 - September 2008
Senior CRA, PAREXEL, Cary, NC April 2005 - August 2007
CRA ICON/BPA, CIN August 2001 – April 2005
Project Leader/ SR CRA, Bailer Research, Overland Park, KS May 1999 - August 2001
Summary of Duties:
Responsibilities included: Total site management and monitoring of Phase 1 - IV drug and device
protocols. Assisted and trained research site staff to ensure the quality and integrity of data, as well as
compliance with GCPs. Assisted in protocol development, creation of monitoring report templates, CRF
completion guidelines, data correction forms, electronic case report forms, and the development of
enrollment/tracking/retention reports. Interacted with PIs, Sub-Is, Site Staff, Vendors, Sponsor and CRO
personnel to carry out these tasks. Performed qualification, initiation, monitoring, termination and CRA
assessment site visits as needed. Trained, mentored, and supervised other less experienced CRAs. Was
the Project Leader on four bioequivalence Tinea protocols. Supervised 6 employees. Functioned as a
Clinical Lead on 4 other trials for CNS, and Parkinson Trials.
Clinical Site Director SMO, PC3, Kansas City, MO October 1998 – April 1999
Clinical director was responsible for the start-up of a new expansion office for site management
organization (SMO). Duties included: physician recruitment and contracting, networking with
local CRA and CRO contacts for study leads, supervision, recruitment, training and hiring of
study coordinators and administrative support staff, negotiation of new office lease, new office
set-up, formulating study budgets, management of office budget, physician and patient
payments, staff payroll and overall Study Management.
Clinical Site Manager SMO, Novum, Kansas City, MO August 1997 – October 1998
Clinical Manager was responsible for the start-up of a new expansion office for site
management organization (SMO) Duties included: physician recruitment and contracting,
networking with local CRA and CRO contacts for study leads, supervision, recruitment, training
and hiring of study coordinators, negotiation of new office lease, new office set-up, formulating
study budgets, management of office budget, physician and patient payments, staff payroll and
overall Study Management.
Page 2 of 16
3. International Medical Technical Associates, Inc., (IMTCI, now PRA International) Lenexa,
KS July 1990 to August 1997
Clinical Research Associate, June 1993-Aug 1997
Conduct site inspections for clinical research studies; review case report forms (CRF) and tag
for corrections; inventory drug supplies; compile monitoring and progress reports to assure
quality assurance; communicate with investigators to maintain study cohesion. Functioned as
Lead CRA on two trials, and also assisted in the on and off site training of new CRAs.
Quality Assurance Clinical Associate, Department of Regulatory Affairs, June 1992-June 1993
Responsible for regulatory audits; quality assurance monitoring of in-house and management
studies; assist in development and review of new and existing SOPs and IOPs; function as
OSHA compliance officer; conduct staff in-service training.
Study Coordinator/Manager July 1990-June 1992
Involved in analysis and conduct of in-house Phase 1-IV studies; including staff supervision of a
team of 8 -10, developed study progress notes and tracked study status on weekly
basis. Performed study related procedures as required. Manager of unit from Jan 1991 to June
1992
Nurse Consultant, MediClaim/Medical Supply Network, Beaverton OR, July 1989 -May
1990
As a Nurse Consultant conducted in-service education to Long Term Care staff in areas of
wound and decubitus care, urinary catheter and ostomy care, enteral feeding and nutrition. I
assisted with proper coding and handling of Medicare A and B patient invoices. I identified
patients for reimbursement qualifications by conducting chart audits to assure proper ICD 9
diagnosis codes and proper caloric calculations for enteral feeding requirements. I developed
and performed in-service education for applicable products and services. I identified and
developed relationships with local medical supply companies for facilities benefit.
Page 3 of 16
4. ALLERGY AND ASTHMA RESEARCH STUDIES
The Efficacy of Theophylline in Decreasing the Use of Inhaled Beta 2-Agonists in
Stable, Mild to Moderate Asthma Patients
Safety and Efficacy of AA-2414 in Patients with Moderate Asthma
The Safety and Pharmacokinetics of Single Oral Doses of ICI 204,219 in Adolescent
Male Asthmatics.
A Randomized, Double Blind, Parallel-Group, Clinical Trial of the Effects of Twelve-
Month Courses of an Investigational Beta-Adrenergic Agonist versus Placebo on
Methacholine-Induced Bronchial Hyper-Responsiveness in Adolescent and Adult
Patients with Chronic Mild-to-Moderate Asthma
A Double Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study of The
Broncho-protective Effect of Albuterol Sulfate Dry Powder Inhaler and Albuterol
Metered-Dose Inhaler (Lead CRA)
Dose Comparison Crossover Study of HFA-134a Salbutamol Sulfate, HFA-134a
Salbutamol Sulfate Placebo Formulation and Ventolin in Patients with Reversible
Obstructive Airway Disease
Dose Comparison Crossover Study of HFA-134a Salbutamol Sulfate, Ventolin, and
Placebo in Patients with Reversible Obstructive Airway Disease
Randomized Double Blind Study of Inhibition of Histamine Skin Wheal Reactions by
Single, Oral Doses of KW4679
A Comparison of the Effect of Acrivastine, Terfenadine and Diphenhydramine Upon
Electrocardiograph Intervals and Cardiac Rhythm in Healthy Male Volunteers.
Multiple Dose Safety and Pharmacokinetics Study of Inhaled ICI 204,219 in Male
Asthmatics
A Double Blind, Randomized Study Comparing the Efficacy and Safety of a Long-Acting
Antihistamine and Placebo in Black Patients with Seasonal Allergic Rhinitis
A Study of Three Dose Levels of Once-A-Day Corticosteroid Nebulizing Suspension
and Placebo in Asthmatic Children Aged Eight Years and Younger
Page 4 of 16
5. DEVICE TRIALS AND OTHER IVDs
Pfizer Consumer Healthcare Protocol B3551003: “Evaluation of the Effect of
Benzonatate on QT Intervals Following Single Dose Administration on Benzonatate to
Healthy Volunteers
Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding
In-line Digestive Enzyme Cartridge RELIZORB™ in Patients with Cystic Fibrosis
Receiving Enteral Tube Feeding
Two-Way Comparison of Hypertension Control Involving Calcium Channel Blockers
found in Hospital Formulary for Cost Reduction Analysis at the VAMC.
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Acute MI with Stent and PCTA versus PCTA and Standard of Care
*Four Cardiac Studies involving Evaluation of new Cardiac Stents for FDA approval
*Three Studies involving Cardiac Embolectomy Devices for FDA approval
Cadillac Controlled Abciximab & Device Investigation to Lower Late Angioplasty
Complications
SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for
Endarterectomy)
*Two studies involving new Carotid Artery stents versus standard of care medication for
FDA approval
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Pan Registry Study involving Medtronic Post Marketing approval devices
Medtronic Adapt Response Study Comparing Cardiac Resynchronization Therapy
(CRT) device AdaptivCRT® (aCRT) algorithm against standard CRT devices in CRT
indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch
block (LBBB).
Page 5 of 16
6. PSYCHIATRY EPILEPSY INSOMNIA RESEARCH STUDIES
A comparison of Zolpidem Tartrate Extended-Release vs. Placebo in the Treatment of
Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used
Concomitantly with Escitalopram (Lexapro
A Multicenter, Randomized, Double blind Placebo Controlled study of the efficacy and
Tolerability of Indiplon therapy Initiated with Sertraline versus Sertraline monotherapy in
Patients with Insomnia and Major Depressive Disorder.
A 2-Year, Prospective, Blinded-Rater, Open-Label, Active-Controlled, Multicenter,
Randomized Study of Long-Term Efficacy and Effectiveness Comparing Risperdal®
Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia
A Multicenter, Open-Label, Pilot Study of Lamotrigine as Adjunctive Therapy and
Monotherapy Patients with Epilepsy and Co morbid Depressive Symptoms.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the
Efficacy and Safety of Once a Day, TAK-375 Tablet for Sublingual Administration (TAK-
375SL Tablet) 0.1, 0.4, and 0.8 mg in the Treatment of Acute Depressive Episodes
Associated with Bipolar 1 Disorder in Adult Subjects who are on Lithium or Valproate
A Randomized, Double Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to
Evaluate the Efficacy and Safety of Once a Day, TAK-375SL 0.1, 0.4, and 0.8 mg as an
Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I
Disorder in Adults and Teens
A Randomized, Single-Blind, Multi-Center Study to assess the Safety and Efficacy of
Medication X in the Treatment of patients with Epilepsy and Depression
Anti-Brain Antibodies in Epilepsy in diagnosed patients under current treatment
A 2 Year, prospective, blinded rater, open label active controlled multi-center
randomized study of long-term efficacy and effectiveness of Risperdal Consta and
Abilify in adults with Schizophrenia.
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-
Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study LTE 6217
(Sanofi-Aventis)
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
Followed by Optional Extension up to 1 Year (Sanofi-Aventis)
Page 6 of 16
7. MIGRAINE CNS AUTOIMMUNE DISEASE RESEARCH STUDIES
An Open Label Study of the Safety and Efficacy of Combination Therapy with
AVONEX® and Bi-Monthly High Dose Intravenous Methotrexate with Leucovorin
Rescue in Multiple Sclerosis
A Phase I Multiple dose Study of the Safety and Tolerability of REGN88 in Rheumatoid
Arthritis Subjects (Regeneron)
A Phase 3, Multicenter, Double-blind, Placebo-controlled Randomized Discontinuation
Study Followed by an Open-label Extension Period to E valuate the Efficacy and Safety
of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with Lambert-
Eaton Myasthenic Syndrome (LEMS)
A Phase III Multicenter, Double Blind, Placebo-controlled, Parallel Group 52-week Study
to Assess the Efficacy and Safety of 2 Dose Regimens of CDP870 as Additional
Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing
Structural Damage in Patients With Active RA Who Have an Incomplete Response to
Methotrexate
A Phase II, Randomized, Double-Blind, Placebo Controlled Study to evaluate the
Preliminary Efficacy, Pharmacokinetics and Immunogenicity of An Experimental
Medication Administered to Subjects with Relapsing-Remitting Multiple Sclerosis.
A Randomized, Single-Blind, Multi-Center Study to assess the Safety and Efficacy of
Medication in the treatment of Early Senile Dementia
A Phase II Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study Of PF-
04447943 In Subjects With Mild To Moderate Alzheimer’s Disease
A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate
the Effects of Daily Administration of AC-1204 in Participants with Mild to Moderate Alzheimer's
Disease (AD) with an Optional 26-Week Open-label Extension (Accera)
A Phase III, Double-Blind, Placebo-Controlled, Multinational Study of the Efficacy,
Safety and Tolerability of Sumanirole and Ropinirole vs. Placebo in Patients with early
Parkinson’s disease.
A Randomized, Placebo-Controlled, Three Treatment Arm Study to Determine the
Safety and Efficacy of an Anti-coagulant Injection in Patients with Acute Ischemic
Stroke.
A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to
Investigate the Effects of Daily Administration of AC-1204 in Participants with Mild to
Moderate Alzheimer's Disease (AD) with an Optional 26-Week Open-label Extension
Page 7 of 16
8. MIGRAINE CNS AUTOIMMUNE DISEASE RESEARCH STUDIES
Self-Administered Sumatriptan Injections Placebo in the Acute Treatment of a Single
Early-Morning Migraine Attack
A Multicenter, Randomized, Open-label Comparison of the Effects of ZOMIG-ZMT(R)
(zolitriptan) and Unusual Migraine Care on Work Loss and Productivity and Patient
Preference.
A Randomized, Single Blind, Multi-Center Study to assess the Safety of the Long-Term
Administration of NBI-34060 in Patients with Primary Insomnia
SN-SIAL-301: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-
Treatment Efficacy and Safety Study of MYOBLOC®
(Part A) Followed by Open-Label,
Multiple-Treatment with MYOBLOC®
(Part B) in the Treatment of Troublesome
Sialorrhea in Adult Subjects
Labrys Biologics LBR-101-022 A Multicenter, Randomized, Double-Blind, Placebo-
Controlled, Parallel-Group, Study Comparing the Efficacy and Safety of Two Doses of
Subcutaneous LBR-101 with Placebo for the Preventive Treatment of High Frequency
Episodic Migraine
Labrys Biologics LBR-101-021 - A Multicenter, Randomized, Double-Blind, Double-
Dummy, Placebo- Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy
and Safety of Subcutaneous LBR-101 with Placebo for the Preventative Treatment of
Chronic Migraine
Page 8 of 16
9. MISC RESEARCH STUDIES (PAIN ONCOLOGY VACCINES)
An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride
Controlled-release Tablets in Opioid Experienced Children from Ages 6 to 16 Years Old,
Inclusive, with Moderate to Severe Malignant and/or Nonmalignant Pain Requiring
Opioid Analgesics
SGI-0470-06: Phase 1 Safety and Pharmacokinetics of Repeated Doses of Oral MP-
470 (Amuvatini) Lipid Suspension Formulation in Healthy Male Subjects (Tyrosine
Kinase Inhibitor)
SGI-0470-06 A Phase 1b 100-patient, 5-arm Phase 1b trial Oral MP-470 (Amuvatini)
Lipid Suspension Formulation
A Phase 1 Randomized, double-blind, placebo-controlled, single ascending dose study
to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC)
REGN1033 (SAR391786) in healthy volunteers.
A Randomized Trial to Evaluate the Safety and Efficacy of LHRH agonist in conjunction
with or in addition to Conventional Therapy (either Tamoxifen or chemotherapy or both)
versus in the Treatment of Breast Cancer in Premenopausal Women (never enrolled)
A Multi-Center Trial of Use of Tamoxifen versus a New Medication in the Treatment of
Stage III Breast Cancer in Post-Menopausal Women with estrogen receptor positive
cancer (never enrolled)
An Open Label Study to Assess the Safety and Tolerability of BEMA® Buprenorphine
NX in Opioid Dependent Subjects in Mucosal Film Format
H1N1 002 (113480) A study to evaluate the safety, immunogenicity, and relative
efficacy of A/California/7/2009 (H1N1) v-like vaccines GSK2340274A and
GSK2340273A in adults aged 18 years and older
Page 9 of 16
10. OPTHAMALOGY
A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and
Pharmacokinetics of iCo-007 Intravitreal Injection in Subjects with Diffuse Diabetic
Macular Edema
A Multi Center Double Masked Phase II study to evaluate the clinical and microbial
efficacy a new compound compared to conventional treatment in the treatment of
bacterial conjunctivitis in children and adults
A Multi Center Placebo Controlled Double-Masked Phase III Study of the Effects on
Visual Loss in Patients with Non Proliferative Diabetic Retinopathy
A Randomized, Double-Masked, parallel Group Comparison of Xalacom™ Given In The
Evening, Xalatan® Given In The Evening, and Timolol™ Given In The Morning In
Subjects With Open Angle Glaucoma or Ocular Hypertension
A Phase 2, Multi-center, Randomized, Controlled, Masked Study of the Effects of
Squalamine Lactate in Combination with Visudyne in Patients with Subfoveal Choriodal
Neovascularization Associated with Age-Related Macular Degeneration
A Phase 2, Multi-center, Randomized, Masked, Controlled, (Squalamine Lactate) for the
treatment of Subfoveal Choroidal Neovascularization Associated with Age-Related
Macular Degeneration
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Ocular Safety
of a drug in Subjects participating in the SPRI PO4737 Study (DCRI)
A Phase I Double Blind, Placebo Controlled Study to Evaluate the Ocular Safety of a
drug in Health Subjects or Subjects with Atherosclerotic Disease (DCRI)
Page 10 of 16
11. DEVICE TRIALS AND OTHER IVDs
Pfizer Consumer Healthcare Protocol B3551003: “Evaluation of the Effect of
Benzonatate on QT Intervals Following Single Dose Administration on Benzonatate to
Healthy Volunteers
Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding
In-line Digestive Enzyme Cartridge RELIZORB™ in Patients with Cystic Fibrosis
Receiving Enteral Tube Feeding
Two-Way Comparison of Hypertension Control Involving Calcium Channel Blockers
found in Hospital Formulary for Cost Reduction Analysis at the VAMC.
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Acute MI with Stent and PCTA versus PCTA and Standard of Care
*Four Cardiac Studies involving Evaluation of new Cardiac Stents for FDA approval
*Three Studies involving Cardiac Embolectomy Devices for FDA approval
Cadillac Controlled Abciximab & Device Investigation to Lower Late Angioplasty
Complications
SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for
Endarterectomy)
*Two studies involving Carotid Artery stents versus standard of care medication for FDA
approval
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Page 11 of 16
12. INFECTIOUS DISEASE, ANTI FUNGALS ANTI MICROBIALS AND DERMATOLOGY
A Phase III, Randomized, Double-Blind, Multi-Center Study to Evaluate the Safety and
Efficacy of Dalbavancin versus Cefazolin in the Treatment of Uncomplicated Skin and
Soft Tissue Infections with Suspected or Confirmed Gram-Positive Bacterial Pathogens
A Phase III, Randomized, Double-Blind, Multi-Center Study to Evaluate the Safety and
Efficacy of Dalbavancin versus Linezolid in the Treatment of Complicated Skin and Soft
Tissue Infections with Suspected or Confirmed Gram-Positive Bacterial Pathogens
A Multi-Center, Prospective, Randomized, Double blind, Parallel Group Comparison of
a 3-Day Treatment Regimen with a 7-Day Treatment Regimen for the Treatment of
Candidiasis
A Three-Way, Randomized Study of an Antibacterial and a New Medication for the
Treatment of Duodenal Ulcers Caused by H-pylori in the Adult Population.
*Four Studies involving Equivalence of a generic versus name brand Anti-Fungal
Medication used for the treatment of Tinea Pedis run by Altana Pharmaceuticals
(Project Manager for 2 of 4)
*A Study involving the dosing Equivalence of a generic versus name brand Anti-
Bacterial Medication used for the treatment of Bacterial Vaginosis run by Altana
Pharmaceuticals (Project Manager)
A Study involving the dosing Equivalence of a generic versus a name brand of Topical
Antibacterial Medication used for the treatment of Adult Rosacea run by Altana
Pharmaceuticals
A Study involving the dosing Equivalence of a generic versus a name brand of Topical
Antibacterial Medication used for the treatment of Acne Vulgaris in teens and adults run
by Altana Pharmaceuticals
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Versus 5% Amorolfine Nail
Lacquer in Patients With Mild to Moderate Toenail Onychomycosis Novartis
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of
REGN668 Administered Subcutaneously by two methods to Healthy Volunteers (atopic
dermatitis)
Page 12 of 16
13. GI, ENDOCRINE AND HEPATITIS
A Multi-center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of
the Efficacy and Safety of Clevudine Compared with Adefovir at Weeks 48 and 96 in
Nucleoside Treatment-Naïve Patients with HBeAg Positive Chronic Hepatitis due to
Hepatitis B Virus (Pharmasset)
Three Protocols for a Three-Way, Randomized Study of an Antibacterial and a New
Medication for the Treatment of Duodenal Ulcers Caused by H-pylori in the Adult
Population. Bristol Myers Squibb
A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-
Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in
Metformin-Treated Subjects With Type 2 Diabetes Mellitus
A Twelve-week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
Safety and Efficacy of 0.5 mg QD, 1mg QD and 1 mg BID of Alosetron in Female
Subjects with Severe Diarrhea Predominant Irritable Bowel Syndrome who Have Failed
Conventional Therapy
Efficacy of Tegasarod in Relieving the Symptoms of Female Patients With Irritable
Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
Safety and Efficacy of Exubera Compared with subcutaneous Human Insulin therapy in
children with Type 1 Diabetes Mellitus (DCRI)
A Phase II Randomized Double-Blind Placebo-Controlled Pharmacodynamics
Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
Page 13 of 16
14. RENAL RESEARCH STUDIES
A PHASE 3b Investigation of Erythropoietin Drugs Using a Specified Dosing Algorithm:
A Randomized Open Label Dosing Study in Adult Chronic Kidney Disease Subjects on
Hemodialysis
A Therapeutic-Equivalence Study Comparing the Efficacy and Safety of Intravenous
Epoetin (Hospira) and Epoetin alfa (Amgen) in Patients with Chronic Renal Failure
Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble
Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving
Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents
(CRUISE 2) Study
An Open-Label, Single-Dose, Pharmacokinetic Study of 10 mg of an Antihistamine in
Volunteers with Various Degrees of Renal Insufficiency.
A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble
Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving
Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents
(CRUISE 1) Study
A Phase 3 Multi-centered Double Blind Placebo Controlled Parallel Arm Trial to
Determine Long term safety and Efficacy of Oral Medication in Patients with Autosomal
Dominant Polycystic Kidney Disease
Outcome Trial Evaluating the Efficacy and Safety of Norditropin in Adult Patients on
Hemodialysis with ESRD (Novo Nordisk)
AbbVie M11-352 SONAR A Randomized, Multicounty, Multicenter, Double Blind,
Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in
Subjects with Type 2 Diabetes and Nephropathy SONAR: Study of Diabetic
Nephropathy with Atrasentan
A 52-Week Trial Involving an Anti-D-hydrotestorerone Compound versus Placebo in
Males with Moderate BPH Symptoms.
Evaluation of Treatment Satisfaction of 25, 50 and 100 mg of Tablet Preparation Used
for Male Subjects with Impotence.
Page 14 of 16
15. PHASE 1 RESEARCH STUDIES
A Phase 1 Study to Evaluate Carry-Over Effect and Intra-Subject Variability of Drug
Dosage Forms and Pharmacokinetics in Subjects with Renal Impairment.
Protocol SGI-0470-06: Phase 1 Safety and Pharmacokinetics of Repeated Doses of
Oral MP-470 Lipid Suspension Formulation in Healthy Male Subjects (SuperGen)
A Placebo-Controlled, Double Blind, Multiple-Dose, Study of the Effect of RP-59227 on
Hypothalamic-Pituitary-Adrenal (HPA) and Renal Function in Man.
An Open-Label, Randomized, Parallel-Group, Single Dose Study to Assess the Effect of
Injection Rate on Safety, Tolerability, Pharmacokinetics, and Immunogenicity of
REGN668 Administered to Healthy Volunteers
A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421
Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies
Exercise Feasibility Trial for the Evaluation of Delayed Onset Muscle Soreness as a
Result of Eccentric Exercise on the Biodex.
A Randomized, Double Blind, Placebo-Controlled, Single, Ascending Dose Study of the
Safety, Tolerability, Pharmacokinetics, and Bioeffect of Intravenously or
Subcutaneously Administered REGN1033 in Healthy Young and Elderly Volunteers
A Double Blind, Placebo-Controlled, Randomized Comparison of an Effervescent
Dosage Form with a Solid Dosage Form in the Treatment of Congestion and Other
Subjective Complaints of the Common Cold in pediatric and adult subjects
Comparison of NSAID Absorption and Elimination Kinetics Following the Oral
Administration of a Single-Dose Administered as a 25 mg Capsule, Two 12.5 mg Direct
Compression Tablets, or Two 12.5 mg Wet Granulation Tablets.
Bioavailability and Dose Proportionality of 50, 75, and 100 mg of a Medication
Administered Twice Daily for 7 Days.
Exercise Feasibility Trial for the Evaluation of Delayed Onset Muscle Soreness Utilizing
the Biodex at 50% and 75% maximum Strength.
Evaluation of the Sensitivity of Delayed Onset Muscle Soreness to Nonsteroidal Anti-
Inflammatory Drug Treatment (Ibuprofen) or Placebo.
Pharmacokinetics of Phenylephrine Following Oral Dosing.
A Pharmacokinetics Study of Diphenhydramine and Phenylpropanolamine in
Effervescent and Non-Effervescent Night Time Combination Cold Formulations.
Page 15 of 16
16. PHASE 1 RESEARCH STUDIES
The Steady-State Pharmacokinetics and Bioavailability of a Controlled Release Entex
PSE Tablet Relative to Corresponding Immediate Release Liquids in Humans.
A Three-Way Crossover Comparison of Ketoprofen Bioavailability Following the Oral
Administration of a Single Dose
Comparison of Study Medication Absorption and Elimination Kinetics Following the Oral
Administration of a Single Dose Administered as a 100 mg Dose in Solution or a 100
mg Dose as a Tablet.
Multiple-Dose, Randomized, Open-Label, Two-Way Complete Crossover, Single-Center
Comparison of the Pharmacokinetics of Pseudoephedrine Hydrochloride Following Oral
Ingestion
Administration of Alka-Seltzer Plus Flu Medicine or Night Time Theraflu Maximum
Strength Flu Cold and Cough Medicine to Normal Healthy Volunteers.
The Human Bioequivalence Study of an Entex PSE Tablet Manufactured at Eaton
Laboratories, Puerto Rico Relative to Entex PSE Manufactured at the North Norwich
Facility.
An Open-Label, Single-Dose, Pharmacokinetic Study of 10 mg of an Antihistamine in
Volunteers with Various Degrees of Renal Insufficiency.
Double Blind, Clinical Efficacy Study Comparing Two Inhalations of Pirbuterol versus
Placebo in a Breath-Actuated Aerosol Inhaler in adult and pediatric population.
A Rising, Single-Dose Study to Determine the Maximum-Tolerated Dose of an Orally
Administered Medication in Healthy Adult Male Volunteers.
The Comparative Steady-State Bioavailability of Theo-24 and Theo-Dur in Healthy Adult
Male Subjects.
A Single-Dose, Food Effects/Bioequivalence Study of Two Ketoprofen Formulations.
A Double Blind, Placebo-Controlled, Dose Tolerance Study to Assess the Effects of
Fluticasone Propionate Aqueous Nasal Spray versus Oral Prednisone on the HPA Axis.
A Rising, Multiple-Dose Study to Determine the Maximum-Tolerated Dose of Orally
Administered SP-303 in Healthy Adult Male Volunteers.
Relative Bioavailability of the Phase III Tablet, Marketed-Image Tablet, and the
Marketed Tablet in Healthy Adult Male Subjects.
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