ProRelix offer several professional, educational and informative services and resources for drug development and analysis on the industry to support clinical research
This document provides an overview of quality improvement methods for healthcare settings. It describes strategies for quality improvement, including the role of leadership in creating a culture that supports quality improvement. The document discusses concepts like the PDSA cycle and foundations of quality improvement developed by thinkers like Shewhart, Deming, and Juran. The goal is to introduce methods that can be used to identify and redesign processes, collect and analyze data, and make improvements to eliminate problems and strategically change healthcare systems over time.
This document provides an overview of quality improvement methods for health care workflows. It describes strategies for quality improvement, including defining measurable goals, implementing process changes through the Plan-Do-Study-Act cycle, and establishing leadership accountability. The need for aggressive quality improvement in health care is discussed to address issues like medical errors. Examples show how projects have redesigned clinical offices and care processes to increase access and efficiency.
ZynxOrder at the 2016 Cerner Middle East Regional User GroupBryony Lott
A short presentation by Mr Grant Goodman, Clinical Transformation Lead at Hamad Medical Corporation (HMC), on the benefits of integrating evidence-based order sets from ZynxOrder into Cerner Millennium.
HMC is the main provider of secondary and tertiary healthcare in Qatar and one of the leading hospital providers in the Middle East. In this presentation HMC describe why they chose ZynxOrder and how evidence-based order sets support their clinical transformation journey, helping to drive CPOE adoption and improve clinical outcomes.
Some considerations when undertaking research within the Critical Care Environment; presentation to students in the Graduate Diploma of Critical Care Nursing - University of Canberra
The document discusses the Bioresearch Monitoring (BIMO) program of the FDA, which aims to protect human subjects, ensure data quality and integrity, and audit clinical research and data. The BIMO program oversees clinical investigators, sponsors, IRBs, and ensures compliance with regulations through inspections and classifications (NAI, VAI, OAI). It also monitors contract research organizations, non-clinical laboratories, and applies regulations on informed consent, financial disclosure, and good clinical practices. The overall goal of the BIMO program is to provide oversight of clinical research and data submitted to the FDA to support new product approvals.
weems-Texas Medicaid Health Home Pilot Project Evaluation MethodsNASHP HealthPolicy
Leslie A. Weems, LMSW, Senior Policy Analyst and Project Manager, Medicaid/CHIP Division, Texas Health and Human Services Commission discusses Texas Medicaid Health Home Pilot Project Evaluation Methods at the New Tactics for Building Medical Homes in State Medicaid and CHIP Programs webinar
Pharmacy practice involves the application of pharmaceutical expertise. It has four main components: promoting health and preventing illness, supplying and using medications related to treatment, self-care advice and provision of treatment for minor ailments, and influencing prescribing and medication use. The article discusses the pharmacist's role in managing medical devices and providing pharmaceutical care, and how a synergistic approach between clinical pharmacy, medical imaging, and nuclear medicine can improve outcomes and reduce healthcare costs.
This document provides contact information for Balu and information about clinical trial processes and SAS software. It includes Balu's contact information for India and the US, an overview of the clinical trial process, definitions of clinical trials and their phases, regulations for human research, and information about SAS as a statistical analysis software. Key players in clinical trials and good clinical practice guidelines are also discussed.
This document provides an overview of quality improvement methods for healthcare settings. It describes strategies for quality improvement, including the role of leadership in creating a culture that supports quality improvement. The document discusses concepts like the PDSA cycle and foundations of quality improvement developed by thinkers like Shewhart, Deming, and Juran. The goal is to introduce methods that can be used to identify and redesign processes, collect and analyze data, and make improvements to eliminate problems and strategically change healthcare systems over time.
This document provides an overview of quality improvement methods for health care workflows. It describes strategies for quality improvement, including defining measurable goals, implementing process changes through the Plan-Do-Study-Act cycle, and establishing leadership accountability. The need for aggressive quality improvement in health care is discussed to address issues like medical errors. Examples show how projects have redesigned clinical offices and care processes to increase access and efficiency.
ZynxOrder at the 2016 Cerner Middle East Regional User GroupBryony Lott
A short presentation by Mr Grant Goodman, Clinical Transformation Lead at Hamad Medical Corporation (HMC), on the benefits of integrating evidence-based order sets from ZynxOrder into Cerner Millennium.
HMC is the main provider of secondary and tertiary healthcare in Qatar and one of the leading hospital providers in the Middle East. In this presentation HMC describe why they chose ZynxOrder and how evidence-based order sets support their clinical transformation journey, helping to drive CPOE adoption and improve clinical outcomes.
Some considerations when undertaking research within the Critical Care Environment; presentation to students in the Graduate Diploma of Critical Care Nursing - University of Canberra
The document discusses the Bioresearch Monitoring (BIMO) program of the FDA, which aims to protect human subjects, ensure data quality and integrity, and audit clinical research and data. The BIMO program oversees clinical investigators, sponsors, IRBs, and ensures compliance with regulations through inspections and classifications (NAI, VAI, OAI). It also monitors contract research organizations, non-clinical laboratories, and applies regulations on informed consent, financial disclosure, and good clinical practices. The overall goal of the BIMO program is to provide oversight of clinical research and data submitted to the FDA to support new product approvals.
weems-Texas Medicaid Health Home Pilot Project Evaluation MethodsNASHP HealthPolicy
Leslie A. Weems, LMSW, Senior Policy Analyst and Project Manager, Medicaid/CHIP Division, Texas Health and Human Services Commission discusses Texas Medicaid Health Home Pilot Project Evaluation Methods at the New Tactics for Building Medical Homes in State Medicaid and CHIP Programs webinar
Pharmacy practice involves the application of pharmaceutical expertise. It has four main components: promoting health and preventing illness, supplying and using medications related to treatment, self-care advice and provision of treatment for minor ailments, and influencing prescribing and medication use. The article discusses the pharmacist's role in managing medical devices and providing pharmaceutical care, and how a synergistic approach between clinical pharmacy, medical imaging, and nuclear medicine can improve outcomes and reduce healthcare costs.
This document provides contact information for Balu and information about clinical trial processes and SAS software. It includes Balu's contact information for India and the US, an overview of the clinical trial process, definitions of clinical trials and their phases, regulations for human research, and information about SAS as a statistical analysis software. Key players in clinical trials and good clinical practice guidelines are also discussed.
This document provides an introduction to clinical trials. It defines a clinical trial as a research study performed on human subjects to determine if a new drug or therapy is both safe and effective. The document outlines the different phases of clinical trials, from pre-clinical testing on animals to post-market surveillance. It describes key terms used in clinical trials and explains the various stakeholders who are involved in and care about clinical trials, such as those in clinical development, business development, marketing, and information professionals. Finally, it discusses some of the main challenges of clinical trials, including demonstrating efficacy and safety, differentiating treatments, and getting regulatory approval.
This document provides an overview of clinical research and clinical trials. It defines clinical trials as carefully conducted studies in human volunteers to determine if a treatment works, works better than other treatments, and has side effects. The document outlines the need for clinical research to develop new and better treatments. It describes the different phases of clinical trials from phase 0 to phase IV and explains the process and various players involved, including regulators, sponsors, clinical research organizations, investigators, and subjects. In closing, it discusses the growing clinical research industry and career prospects in the field.
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
CPHQ certification is “world class” in the field of healthcare quality. Which certify that as a professional you are privileged to take the lead for Healthcare Quality Management Structure, Process and Evaluation within a healthcare organization. CPHQ is beneficial for both quality professional and managerial position in healthcare facility
Importance of clinical trials in drug developmentDevanshKarnani2
The pharmaceutical industry is constantly going through rapid growth and progress in creation of new medication and drugs to combat the pandemic and its effects. The pharmaceutical industry is undergoing drastic changes in their methods of production with more and more organisations realising the sheer importance of clinical trials and research and how much it aides them in the development of drugs for disease.
Accredited hospitals offer higher quality care to patients and gain a competitive advantage over non-accredited hospitals by strengthening community confidence in the quality, safety, and services provided. Accreditation standards focus on patient-centered care, patient and family rights, clinical assessment and care, quality improvement, infection control, facility safety management, governance, staff qualification, and information management. The accreditation process involves assessment against these standards.
Clinical research involves investigating medical treatments and devices with human subjects to determine safety and effectiveness, and can include clinical trials, mechanisms of disease, and outcomes research. A sponsor initiates and finances clinical trials and is responsible for selecting qualified investigators, while investigators ensure ethical conduct of the trial and respect for subjects. Clinical research associates support investigators and sponsors in carrying out clinical trials.
This document discusses key considerations for developing inhaled pharmaceuticals, including both small molecule and biopharmaceutical compounds. There are shared approaches for both types of compounds, such as measuring drug exposure, dosing methodology, and lung deposition. However, there are also specific considerations for biopharmaceuticals, like increased potential for immunogenicity and the need for activity assays to confirm potency after aerosolization. The document promotes Covance as offering expertise and capabilities to support inhaled product development and regulatory submissions.
Clinical SAS Programming | SAS Training | Big Data | Hadoop | Business Analyt...Epochresearch
Clinical SAS
This bootcamp training program will not only cover detail about data manipulation, generation of tables and graphs but it also make you industry ready with clinical research theory and case studies based on phase trials. This program also help candidate in preparation of SAS Certified Clinical SAS Programmer credentials. Participants get one complimentary attempt for Base SAS and Advanced SAS Certification Exams. Participants needs to complete 7 days project as part of their bootcamp. The project includes following topics
Learn how to
• Clinical trials process
• Accessing, managing, and transforming clinical trials data
• Statistical procedures and macro programming
• Reporting clinical trials results
• Validating clinical trial data reporting.
For more information you can drop your mails on info@epoch.co.in
#clinicalsasprogramming #clinicalsas #sastraining #clinicalsasprogrammer #hadoop #bigdata
Quality assurance in community health nursingJobin Jacob
Quality assurance in community health nursing aims to ensure delivery of quality patient care and demonstrate efforts to achieve optimal outcomes. It involves evaluating the structure, processes, and outcomes of care. Approaches include general methods like credentialing, licensing, and certification as well as specific techniques like peer review, utilization review, and patient satisfaction surveys. The goals are to identify issues, intervene in problems, provide feedback, and document the provider-patient interaction to continually improve the quality of care.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Quality assurance in nursing involves identifying standards of excellence, evaluating care against those standards, and taking action to correct deficiencies. It aims to introduce codes of ethics, strengthen documentation, provide optimal resource utilization, and increase professionalism. Some key components of quality assurance are defining, promoting, monitoring and taking action. General approaches include credentialing, licensure, accreditation and certification. Specific approaches are nursing audits and standards. Common models are the system model and American quality assurance model.
The document discusses quality improvement for reducing diarrhea cases through a handwashing program. It proposes using the FADE model and microsystems approach to design the program. Measurement tools would quantitatively and qualitatively assess handwashing rates, diarrhea incidence, and impact. Ethical considerations include informed consent, confidentiality, and balancing risk of spreading infection against the duty to protect patients. Overall the program aims to determine if handwashing increases and diarrhea cases decrease.
Quality assurance in health care system and the nurse's role in maintaining and supporting the quality assurance. quality control,quality maintenance and models of quality assurance are included.
The document outlines the multi-step process for new drug development from research and discovery through clinical trials and regulatory approval. It involves early research, preclinical testing in labs and animals, and four phases of clinical trials in humans to test safety, efficacy, and get regulatory clearance. Phase 1 trials test safety in a small group, Phase 2 expands to test biological activity and potential efficacy, and Phase 3 tests therapeutic effects in large trials to confirm efficacy and comparative effectiveness for regulatory approval and launch.
This document provides an overview of clinical research and clinical trials. It defines clinical research and clinical trials, discusses the importance of research. It describes the different types and phases of clinical trials, from phase 0 to phase IV. It outlines the key players involved in clinical trials and provides an overview of the clinical trial process from study design to statistical analysis and reporting.
Journal of Bioequivalence Studies (JBS) is an open access, peer reviewed journal that publishes the most relevant and reliable researches with respect to the subject of Bioequivalence studies which includes pharmacokinetic and pharmcodynamic properties of a drug. JBS publishes original articles, review articles, case reports, short communications, etc.
El documento trata sobre el superestructuralismo en España. Explica que el superestructuralismo en España toma tres formas: de izquierda, nacionalista y de izquierda y nacionalista. Además, señala que en el superestructuralismo de izquierda hay dos referencias teóricas claras aunque su uso sea confuso y haya experimentado actualizaciones. También menciona que el Fondo Monetario Internacional ha actualizado las previsiones de crecimiento de España para 2015 y 2016.
Blockchains and analytics can both help address challenges in the healthcare industry. Blockchains can help provide secure and interoperable sharing of medical records between institutions to allow patients access to the best outcomes. Analytics using technologies like Watson can provide insights from medical data to help develop new treatments and technologies. By removing barriers with blockchains, analytics can further improve healthcare effectiveness and efficiency and empower consumers to be more accountable for their health with access to insights.
This document provides an introduction to clinical trials. It defines a clinical trial as a research study performed on human subjects to determine if a new drug or therapy is both safe and effective. The document outlines the different phases of clinical trials, from pre-clinical testing on animals to post-market surveillance. It describes key terms used in clinical trials and explains the various stakeholders who are involved in and care about clinical trials, such as those in clinical development, business development, marketing, and information professionals. Finally, it discusses some of the main challenges of clinical trials, including demonstrating efficacy and safety, differentiating treatments, and getting regulatory approval.
This document provides an overview of clinical research and clinical trials. It defines clinical trials as carefully conducted studies in human volunteers to determine if a treatment works, works better than other treatments, and has side effects. The document outlines the need for clinical research to develop new and better treatments. It describes the different phases of clinical trials from phase 0 to phase IV and explains the process and various players involved, including regulators, sponsors, clinical research organizations, investigators, and subjects. In closing, it discusses the growing clinical research industry and career prospects in the field.
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
CPHQ certification is “world class” in the field of healthcare quality. Which certify that as a professional you are privileged to take the lead for Healthcare Quality Management Structure, Process and Evaluation within a healthcare organization. CPHQ is beneficial for both quality professional and managerial position in healthcare facility
Importance of clinical trials in drug developmentDevanshKarnani2
The pharmaceutical industry is constantly going through rapid growth and progress in creation of new medication and drugs to combat the pandemic and its effects. The pharmaceutical industry is undergoing drastic changes in their methods of production with more and more organisations realising the sheer importance of clinical trials and research and how much it aides them in the development of drugs for disease.
Accredited hospitals offer higher quality care to patients and gain a competitive advantage over non-accredited hospitals by strengthening community confidence in the quality, safety, and services provided. Accreditation standards focus on patient-centered care, patient and family rights, clinical assessment and care, quality improvement, infection control, facility safety management, governance, staff qualification, and information management. The accreditation process involves assessment against these standards.
Clinical research involves investigating medical treatments and devices with human subjects to determine safety and effectiveness, and can include clinical trials, mechanisms of disease, and outcomes research. A sponsor initiates and finances clinical trials and is responsible for selecting qualified investigators, while investigators ensure ethical conduct of the trial and respect for subjects. Clinical research associates support investigators and sponsors in carrying out clinical trials.
This document discusses key considerations for developing inhaled pharmaceuticals, including both small molecule and biopharmaceutical compounds. There are shared approaches for both types of compounds, such as measuring drug exposure, dosing methodology, and lung deposition. However, there are also specific considerations for biopharmaceuticals, like increased potential for immunogenicity and the need for activity assays to confirm potency after aerosolization. The document promotes Covance as offering expertise and capabilities to support inhaled product development and regulatory submissions.
Clinical SAS Programming | SAS Training | Big Data | Hadoop | Business Analyt...Epochresearch
Clinical SAS
This bootcamp training program will not only cover detail about data manipulation, generation of tables and graphs but it also make you industry ready with clinical research theory and case studies based on phase trials. This program also help candidate in preparation of SAS Certified Clinical SAS Programmer credentials. Participants get one complimentary attempt for Base SAS and Advanced SAS Certification Exams. Participants needs to complete 7 days project as part of their bootcamp. The project includes following topics
Learn how to
• Clinical trials process
• Accessing, managing, and transforming clinical trials data
• Statistical procedures and macro programming
• Reporting clinical trials results
• Validating clinical trial data reporting.
For more information you can drop your mails on info@epoch.co.in
#clinicalsasprogramming #clinicalsas #sastraining #clinicalsasprogrammer #hadoop #bigdata
Quality assurance in community health nursingJobin Jacob
Quality assurance in community health nursing aims to ensure delivery of quality patient care and demonstrate efforts to achieve optimal outcomes. It involves evaluating the structure, processes, and outcomes of care. Approaches include general methods like credentialing, licensing, and certification as well as specific techniques like peer review, utilization review, and patient satisfaction surveys. The goals are to identify issues, intervene in problems, provide feedback, and document the provider-patient interaction to continually improve the quality of care.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Quality assurance in nursing involves identifying standards of excellence, evaluating care against those standards, and taking action to correct deficiencies. It aims to introduce codes of ethics, strengthen documentation, provide optimal resource utilization, and increase professionalism. Some key components of quality assurance are defining, promoting, monitoring and taking action. General approaches include credentialing, licensure, accreditation and certification. Specific approaches are nursing audits and standards. Common models are the system model and American quality assurance model.
The document discusses quality improvement for reducing diarrhea cases through a handwashing program. It proposes using the FADE model and microsystems approach to design the program. Measurement tools would quantitatively and qualitatively assess handwashing rates, diarrhea incidence, and impact. Ethical considerations include informed consent, confidentiality, and balancing risk of spreading infection against the duty to protect patients. Overall the program aims to determine if handwashing increases and diarrhea cases decrease.
Quality assurance in health care system and the nurse's role in maintaining and supporting the quality assurance. quality control,quality maintenance and models of quality assurance are included.
The document outlines the multi-step process for new drug development from research and discovery through clinical trials and regulatory approval. It involves early research, preclinical testing in labs and animals, and four phases of clinical trials in humans to test safety, efficacy, and get regulatory clearance. Phase 1 trials test safety in a small group, Phase 2 expands to test biological activity and potential efficacy, and Phase 3 tests therapeutic effects in large trials to confirm efficacy and comparative effectiveness for regulatory approval and launch.
This document provides an overview of clinical research and clinical trials. It defines clinical research and clinical trials, discusses the importance of research. It describes the different types and phases of clinical trials, from phase 0 to phase IV. It outlines the key players involved in clinical trials and provides an overview of the clinical trial process from study design to statistical analysis and reporting.
Journal of Bioequivalence Studies (JBS) is an open access, peer reviewed journal that publishes the most relevant and reliable researches with respect to the subject of Bioequivalence studies which includes pharmacokinetic and pharmcodynamic properties of a drug. JBS publishes original articles, review articles, case reports, short communications, etc.
El documento trata sobre el superestructuralismo en España. Explica que el superestructuralismo en España toma tres formas: de izquierda, nacionalista y de izquierda y nacionalista. Además, señala que en el superestructuralismo de izquierda hay dos referencias teóricas claras aunque su uso sea confuso y haya experimentado actualizaciones. También menciona que el Fondo Monetario Internacional ha actualizado las previsiones de crecimiento de España para 2015 y 2016.
Blockchains and analytics can both help address challenges in the healthcare industry. Blockchains can help provide secure and interoperable sharing of medical records between institutions to allow patients access to the best outcomes. Analytics using technologies like Watson can provide insights from medical data to help develop new treatments and technologies. By removing barriers with blockchains, analytics can further improve healthcare effectiveness and efficiency and empower consumers to be more accountable for their health with access to insights.
Jhoanna D. Ignalig has over 12 years of experience as a Senior Business Systems Analyst at Safeway Manila, where she has led various projects involving testing, defect management, and process improvements. Her roles have included Test Coordinator, Shift Lead, Tester, and Backup Test Coordinator. She has also worked in human resources and as a vendor relations coordinator. Ignalig holds a Bachelor's degree in Industrial Psychology from Rizal Technological University and has attended numerous training seminars on topics such as project management, software testing, communication, and customer service.
Anthony Gee is the product manager at Fireaway and has over 20 years of experience in the fire protection industry. The document discusses condensed aerosol fire suppression technology as an alternative to Halon 1301. Condensed aerosol systems use potassium-based compounds in micron-sized particles to suppress fires. They have been commercially available internationally for over a decade and NFPA and UL now recognize them as a viable technology. Fireaway's Stat-X line of condensed aerosol systems are UL listed and EPA approved as a Halon alternative.
El documento habla sobre las principales amenazas a la computadora como virus, gusanos, spyware, phishing y spam. Explica que el spyware y adware se pueden descargar de sitios web y recolectan información del usuario, mientras que el malware y los virus ejecutan código dañino. También advierte que las computadoras pueden usarse para acosar a otros y que guardan un registro de sitios visitados, por lo que se deben tomar precauciones como usar candados y alarmas para portátiles.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
El documento trata sobre la transformación de la naturaleza a través del desarrollo de la tecnología y la ingeniería genética para dominar y explorar la naturaleza. Explica que los productos transgénicos inicialmente se enfocaron en agricultura y ganadería, pero luego también se aplicaron a alimentos. También describe cómo la biología molecular permite incorporar material genético de un organismo a otro de manera más rápida y eficiente que antes.
A secretaria da educação ofereceu um dia especial para alunos de um projeto na escola. Os alunos vivenciaram aprendizagem criativa através do uso de sucata e equipamentos de robótica.
Carlos Coleman is a senior recruiter and HR generalist with over 10 years of experience in full-cycle recruiting and onboarding. He has worked in recruiting roles for various transportation, consulting, security, and investment companies. His experience includes applicant tracking, screening, interviews, training, market analysis, and maintaining relationships with hiring managers. He holds specialized training in recruiting and leadership and has received awards for his recruiting achievements and community outreach programs.
Ahmed Ezzat Abd ElFadeel has over 10 years of experience in IT support and system administration. He received a B.Sc. in Management Information Systems in 2007. His most recent role was as an IT Specialist at Raya Restaurants from 2016 to present, where his responsibilities included hardware and software maintenance, data backups, and handling user support tickets. Prior to that, he worked as a Senior IT Specialist from 2012 to 2016 and has experience administering networks, databases, and email systems.
Ochrona klientów porównanie zabezpieczeń bankowych oraz platformy wymiany w...Sylwester Suszek
Prezentacja Sylwestra Suszek pt."Ochrona klientów porównanie zabezpieczeń bankowych oraz platformy wymiany walut" podczas konferencji "PŁATNOŚCI ELEKTRONICZNE. PRAWNE, FINANSOWE I EKONOMICZNE UJĘCIE WALUT WIRTUALNYCH I CYFROWYCH", która miała miejsce 26 marca 2015 roku na
Wydziale Prawa, Administracji i Ekonomii Uniwersytetu Wrocławskiego we Wrocławiu.
Transakcje przy użyciu waluty bitcoin na tle pozostałych form płatności mobil...Sylwester Suszek
Prelekcja podczas spotkania 10 marca 2016 r. w Warszawie pt.: "Płatności mobilne, zbliżeniowe, HCE – gdzie jesteśmy, dokąd zmierzamy
Sesja XXIX w cyklu „Polskie Karty i Systemy”,
El documento habla sobre las etiquetas más importantes del lenguaje HTML. Menciona etiquetas como <html>, <head>, <body>, <title>, <b>, <table> e <img> y explica brevemente para qué sirve cada una. También define qué son las etiquetas en HTML y explica que HTML es el lenguaje utilizado para crear páginas web, compuesto por etiquetas que el navegador interpreta para mostrar contenido formato como texto, imágenes e hipervínculos.
This document contains a cover letter and resume for Jonathan Tanner. It includes his contact information, career focus, skills summary, accomplishments in previous roles, professional experience including positions at Freight Handlers Inc., Overhead Door Co. of Atlanta, and Staples, and education history. The resume highlights Jonathan's customer service experience, leadership skills, problem solving abilities, and success increasing revenue, safety records, and decreasing overtime and turnover in previous roles.
A Sample Presentation on - Clinical research training program Deepak Kushwaha
This document discusses building a partnership between Biosyss and educational institutions to provide training programs in clinical research. It notes that over 500 institutes educate over 1.15 lakh students in biotech annually, but that job opportunities are limited. The training programs aim to increase students' employability in clinical research profiles like R&D, operations, quality, clinical research, finance, and business development. Biosyss and Ziven Consulting will offer certificates in GCP and clinical research to help students enter the industry. Their experienced team will provide quality, affordable training with placement assistance to nurture talent for clinical research careers.
Naila Kanwal's document summarizes the new drug development and approval process. It describes the preclinical research phase involving animal and lab testing to determine safety and effectiveness. It then explains the clinical trial phases involving human subjects to further evaluate these factors. The document outlines the steps of submitting an Investigational New Drug application to the FDA for review and potential approval or requests for additional information before studies can begin. The overall process is designed to demonstrate a new drug is safe and effective for its intended use before being approved and marketed to the public.
VAC3 Clinical Services is an Indian clinical research organization established in 2010 that provides global standard clinical and medical services including medical writing, clinical research, investigator selection and training, and regulatory consultation, focusing on therapeutic areas like oncology, cardiology, and neurology. Their team of experts have decades of experience in areas like clinical research, drug development, and medical marketing. They have conducted seminars on topics like drug development processes and ethics in clinical research.
Discovery of Drug and Introduction to Clinical Trial__Katalyst HLSKatalyst HLS
This document provides an overview of the drug discovery and clinical trials process. It discusses the goals of drug discovery which include identifying new chemical entities and developing medicines to address unmet medical needs. The drug discovery process involves target identification, validation, lead generation, and optimization. Pre-clinical testing is then conducted to evaluate safety and effects. If successful, an investigational new drug application is filed with the FDA prior to beginning clinical trials. Clinical trials involve 4 phases to test safety and efficacy in humans. Upon completion, a new drug application can be filed for FDA review and potential approval.
Altasciences Clinical Research offers comprehensive Phase I/II drug development services including clinical trials, bioanalysis, data management, biostatistics, and regulatory support. They have facilities in the US and Canada with over 600 beds and can rapidly recruit from a database of over 225,000 volunteers. Altasciences is committed to quality, safety, and compliance in conducting clinical trials to help customers develop new drugs.
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLSKatalyst HLS
Introduction to Discovery of Drug and Introduction to Clinical Trials in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Exodon offers comprehensive CRO services including patient recruitment, site selection and management, and clinical trials for various therapeutic areas such as oncology, cardiology, and infectious diseases. It conducts most studies in its own clinical research units located around the world to have more control over projects and reduce costs. Exodon provides timelier and more affordable clinical trial solutions through its experienced in-house team and state-of-the-art research units.
This document provides an overview of the drug development process, which includes early drug discovery through preclinical research on animals, clinical trials with human subjects in four phases, regulatory review and approval, and post-marketing safety surveillance. The process aims to determine if a new drug is safe, effective for its intended use, and has the proper dosage before it can reach patients, and typically takes over a decade. Key steps include identifying drug targets, developing and screening candidate compounds, optimizing leads, conducting preclinical and clinical trials to test safety and efficacy, obtaining regulatory approval, and ongoing monitoring after approval.
The document discusses the complex and unpredictable nature of the FDA drug approval process. While the steps of drug development may seem formulaic, including discovery, preclinical testing, and clinical trials, success is not guaranteed as programs face many risks and intangible factors. Understanding these challenges is important for mitigating risks and strategizing development approaches. The FDA approval process aims to ensure new drugs are safe and effective for patients.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
Altasciences Clinical Research offers comprehensive Phase I/II drug development services including clinical trials, bioanalysis, data management, biostatistics, and regulatory support. They have facilities in the US and Canada with over 600 beds and can rapidly recruit from a database of over 225,000 volunteers. Altasciences focuses on customized solutions and meeting timelines to provide value to their pharmaceutical and biotech customers.
The document describes an upcoming summit hosted by the Avoca Quality Consortium in 2013. The Consortium brings together quality, outsourcing, and operational professionals from pharmaceutical, biotech, and clinical research organizations to develop best practices for proactive quality management in outsourced clinical trials. The summit will feature sessions on finding the right balance between timelines, costs, and quality in clinical trials, and will include discussions on effective oversight, risk assessment, risk management, and culture in ensuring quality. Industry leaders will also discuss key imperatives for quality moving forward.
Medical affairs department for small organizationDr. Zubair Ali
The document summarizes the drug development process and the role of medical affairs departments within pharmaceutical companies. It discusses the various phases of clinical drug trials from phase I to phase IV. It then outlines the structure and responsibilities of medical affairs, including clinical research, pharmacovigilance, medical information services, statistics management, and providing medical support to marketing and sales teams. A key part of medical affairs is the medical science liaison program which aims to educate medical professionals and support clinical trial recruitment through relationship building.
This document provides an overview of the scope of pharmacology. It discusses the history and evolution of pharmacology from materia medica and early pharmacy to its modern academic, industrial and research applications. Key areas of pharmacology discussed include drug development process, clinical pharmacology, special domains like pharmacovigilance, pharmacoeconomics and emerging areas like pharmacogenomics. The document outlines the past, present and future scope of pharmacology and how it aims to advance human health through rational and safe use of medicines.
Pacific BioLabs can assist with all stages of drug development through their scientists and testing services. The drug development process involves several stages including discovery, product characterization, formulation and delivery testing, preclinical toxicology testing and clinical trials. Pacific BioLabs' experienced staff can perform the necessary tests and studies to help drugs progress through these stages and gain FDA approval.
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
regulatory requirements for drug approval ( IP-2 / UNIT -3 )JAYACHANDRA AKUTHOTA
The document discusses regulatory requirements for drug approval. It covers the drug development process including non-clinical and clinical development teams. The non-clinical team conducts pre-clinical studies in animals to evaluate efficacy, safety, and viability of manufacturing. Clinical trials have multiple phases to test drugs on humans. A New Drug Application is submitted to regulatory authorities for marketing approval and includes preclinical and clinical data. The drug development process takes 10-12 years and involves interactions between scientific disciplines.
This document appears to be a thesis submitted by Mr. Lahare Nikhil Ashok in partial fulfillment of the requirements for a Master of Science degree in Clinical Research. The thesis involves a randomized clinical study assessing the safety and efficacy of topical dexketoprofen gel in treating knee osteoarthritis. The study was conducted at Hardikar Hospital in Pune under the guidance of Dr. Madan Hardikar. The thesis contains sections on the introduction, aim and objectives, materials and methods, project management, statistical analysis, results and conclusions, discussion, and references.
Real World Late Phase The right approach for the right questionSatish Kumar
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2. “ProRelix offer several professional, educational and informative services and
resources for drug development and analysis on the industry to support clinical
research. We specialize in a wide range of tools and resources to aid patient
and investigator recruitment, remain current with industry trends and business
practices, and strengthen organizational procedures. Our strong database and
a fine assortment of industry resources make us an adept organization. In a
highly fragmented industry, we are one of a group of organizations with the
capability and expertise to conduct clinical research, on either a local or global
scale. We have the operational flexibility to provide drug development services
on a stand-alone basis or as part of an integrated full service solution.”
“In a highly fragmented industry, we are one of a group of organizations with
the capability and expertise to provide drug development services.”
Relix | Lifesciences Pvt.
Ltd.
3. Mission
To provide world class services to improve the quality of health care and
reduce the efforts of our client in order to accelerate the overall process of
drug development. We provide customized and effective solutions as per
the needs and objectives of each task, all while complying with the highest
international quality standards and practices.
Vision
As we move towards our goal of becoming a world class organization, our
vision is to scale the great heights of innovation and outstanding services in
order to maximize the returns to our partners and to allocate capital
profitability toward growth initiatives of the company.
MISSION & VISION
4.
5.
6. What is Clinical Study?
“Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or
other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption, distribution metabolism, and excretion of an investigational
product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
synonymous. - ICH GCP”
Phase 0
or Micro
Dosing
Phase 1
1st in humans,
evaluates
safety,
determine a
safe dose, and
identify side
effects
Phase2
Evaluate safety
and efficacy on a
comparatively
large group
Phase 3
Tested on large
group of people
to confirm
safety, efficacy,
comparison
over existing
drug, quality of
life
Phase 4
Conducted after
marketing of drug
also called as
post marketing
surveillance
Clinical Trials Post Marketing Study
Discovery Phase
7.
8. • B.Sc./ M.Sc. in Life Sciences/ Microbiology/
Biotechnology/ Zoology/ Biochemistry/
Chemistry/ Nursing
• B.Pharm/ M.Pharm
• BAMS/ BHMS/ BDS/ MBBS/ Physiotherapy
Who Can Participate in a CLINICAL
RESEARCH course?
9. • 6 Months Duration
• Comprehensive Syllabus of Clinical
Research, Pharmacovigilance and
Clinical Data Management Subjects
• Internship Opportunity
• Guest Lectures by Industry People
• Workshop on Interview Techniques
• CV Development
• Placement support Program
• Classroom Lectures
• Presentations & Discussions
• Assignments/ Projects
• Written Exam Based Evaluation
Highlights
Teaching
Methodology
10. Job Positions in Clinical
Research
•Clinical Trial Associate •Medical Coder
•Clinical Research
Coordinator
•Medical Writer
•Clinical Research
Associate
•Business Development
Executive
•Data Safety Associate •Quality Assurance
Associate
•Regulatory Associate •Trainer
•Investigator •Clinical Data Associate
11. CR Industry is in search
of…
- Qualified &
Competent People
- Relevant Education
in Clinical Research
- Good
Communication Skill
12. 202 B, Park Plaza,
Karve Nagar, Pune,
India-52
+91 20 6560 1030
info@prorelix.com
Lifesciences Pvt. Ltd.
USA Partner:
Atlantis Clinical Trials
West Palm Beach, Florida, USA
+1 (561) 855 0645
atlantisclinicaltrials@gmail.com
UK Partner:
Cellomatics Biosciences
Biocity, Nottingham, UK
+44 (115) 787 0081
info@cellomaticsbio.com
“Interdependence is superior than dependence and
Independence’’
www.prorelix.com