Pentha Research Capabilities
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Pentha Research is a full-service CRO covering South America and Mexico. In addition to standard CRO services like clinical trial management, regulatory affairs, and quality assurance, Pentha also has an R&D department developing new medical technologies and an early phase development division for Phase I/II trials. The company was founded in 2003 in Buenos Aires, Argentina and assists pharmaceutical, biotech, and medical device companies through all stages of product development.
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Ivy McClinton has over 20 years of experience working in various patient service and medical records roles. She currently works as a Patient Service Representative at Penn Medicine, where her responsibilities include scheduling appointments, processing medical billing, updating patient registration information, triaging phone calls, and assisting patients. Previously, she held similar roles at other medical practices, demonstrating a long career supporting physicians and providing customer service to patients.
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Liudmyla Kovalenko has over 5 years of experience as a certified pharmacy technician in retail, long-term care, and outpatient pharmacy settings. She has strong skills in filling prescriptions, data entry, insurance billing, customer service, medication compounding, and IV mixing procedures. Kovalenko is licensed as a Pharmacy Technician A in Washington state and has worked as a pharmacy technician at Fred Meyer in Bothell, as an on-call technician at Providence Outpatient Pharmacy in Everett, and as a triage pharmacy technician at Omnicare of Seattle. She holds an Associate of Science degree in Pre-Nursing from Edmonds Community College and an Associate
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Savy Sangha has over 12 years of experience as a certified pharmacy technician, with expertise in compounding. She possesses a certificate in pharmacy technology from Foothill College as well as pharmacy technician certification. Her skills include medication compounding, patient care, inventory management, and software systems used in pharmacy. Currently she works as a compounding pharmacy technician at Haller's Pharmacy, where her duties include entering prescriptions, providing customer service, dispensing medications accurately, and maintaining compliance and inventory.
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Susan Jackson has over 10 years of experience as an executive administrative assistant. She has held roles providing support to senior executives and collecting consumer data for nationwide companies. Her experience also includes working as a patient services lead and representative, where she assisted with medical imaging and provided customer service. She is seeking new opportunities as an executive assistant.
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Melinda Ross has 18 years of experience as a lead medical coder specializing in outpatient surgery coding. She is certified in ICD-9 and ICD-10 coding and has experience with both commercial and private insurance carriers. Ross has an Associate's degree in Health Information and is a member of AHIMA. Her skills include coding for ambulatory surgery, observations, clinics, and interventional radiology using various software programs.
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This document contains the resume of Raylynn Huck. It lists her contact information, skills which include billing, collections, customer service and medical terminology. Her work experience spans from 1998 to present and includes positions as a receptionist, registration specialist, assembly line worker, insurance verification specialist, and scheduling coordinator for both pediatric specialties and gastroenterology. Her roles involved insurance verification, coding, obtaining authorizations, data entry, and coordinating patient appointments, tests and equipment. She has over 20 years of experience in medical offices.
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South Cone Alliance is a multinational clinical research organization founded in 2011 by Clinical Trials Support in Chile and Pentha Research in Argentina. It provides full clinical research services across Latin America through local offices and affiliates in 8 countries. South Cone Alliance offers feasibility studies, regulatory support, site start up, project management, clinical trial management, pharmacovigilance, quality assurance, early phase facilities, and GCP training to pharmaceutical clients.
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Ivy McClinton has over 20 years of experience working in various patient service and medical records roles. She currently works as a Patient Service Representative at Penn Medicine, where her responsibilities include scheduling appointments, processing medical billing, updating patient registration information, triaging phone calls, and assisting patients. Previously, she held similar roles at other medical practices, demonstrating a long career supporting physicians and providing customer service to patients.
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Jared Alexi has over 25 years of experience as a Medical Records Clerk Tech and Receptionist. He has extensive skills in customer service, problem solving, communication, and conflict resolution. As a Medical Records Clerk Tech at Island Hospital since 1995, his responsibilities include chart assembly, deficiency procedures, filing birth certificates, abstracting, coding, reception duties, and release of information in compliance with HIPAA rules. He has participated in several hospital teams and earned certificates in medical terminology, anatomy, and coding systems.
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Liudmyla Kovalenko has over 5 years of experience as a certified pharmacy technician in retail, long-term care, and outpatient pharmacy settings. She has strong skills in filling prescriptions, data entry, insurance billing, customer service, medication compounding, and IV mixing procedures. Kovalenko is licensed as a Pharmacy Technician A in Washington state and has worked as a pharmacy technician at Fred Meyer in Bothell, as an on-call technician at Providence Outpatient Pharmacy in Everett, and as a triage pharmacy technician at Omnicare of Seattle. She holds an Associate of Science degree in Pre-Nursing from Edmonds Community College and an Associate
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Savy Sangha has over 12 years of experience as a certified pharmacy technician, with expertise in compounding. She possesses a certificate in pharmacy technology from Foothill College as well as pharmacy technician certification. Her skills include medication compounding, patient care, inventory management, and software systems used in pharmacy. Currently she works as a compounding pharmacy technician at Haller's Pharmacy, where her duties include entering prescriptions, providing customer service, dispensing medications accurately, and maintaining compliance and inventory.
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Susan Jackson has over 10 years of experience as an executive administrative assistant. She has held roles providing support to senior executives and collecting consumer data for nationwide companies. Her experience also includes working as a patient services lead and representative, where she assisted with medical imaging and provided customer service. She is seeking new opportunities as an executive assistant.
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Melinda Ross has 18 years of experience as a lead medical coder specializing in outpatient surgery coding. She is certified in ICD-9 and ICD-10 coding and has experience with both commercial and private insurance carriers. Ross has an Associate's degree in Health Information and is a member of AHIMA. Her skills include coding for ambulatory surgery, observations, clinics, and interventional radiology using various software programs.
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This document contains the resume of Raylynn Huck. It lists her contact information, skills which include billing, collections, customer service and medical terminology. Her work experience spans from 1998 to present and includes positions as a receptionist, registration specialist, assembly line worker, insurance verification specialist, and scheduling coordinator for both pediatric specialties and gastroenterology. Her roles involved insurance verification, coding, obtaining authorizations, data entry, and coordinating patient appointments, tests and equipment. She has over 20 years of experience in medical offices.
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Bilal J. Albtoush is a licensed pharmacist seeking a position in pharmacy. He holds a Bachelor's degree in pharmacy from the University of Damascus and has passed the FPGEE and PTCB exams. Bilal has over 8 years of experience working in pharmacies in Jordan and as a medical representative in addition to his current role as a pharmacy technician at Walgreens. He is proficient in English and computers and has received various academic and athletic awards.
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Froedtert Hospital is inviting recent pharmacy program acceptances to apply for their pharmacy internship program. The internship provides opportunities for professional development and skills training to become a well-rounded clinical pharmacist. Interns gain experience in central pharmacy duties, clinical services like medication histories and counseling, and networking with healthcare professionals. The program offers part-time hours during the academic year with potential for more hours in the summer. Application is due by August 5th and materials should be emailed to the program director.
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Patricia Haiby seeks an outpatient or inpatient coding specialist position. She has advanced knowledge of medical coding guidelines and experience coding for outpatient, inpatient, medical surgical, obstetrics, swing bed, wound care and ambulance services. As a current coding specialist, she reviews medical records to ensure coding compliance and assigns accurate diagnosis, procedure and evaluation and management codes. Previously, she held human resources and executive assistant roles managing schedules, employee relations, and compliance. She has an associate degree in health information technology and is a registered health information technician and certified ambulance coder.
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This document is a resume for Deneen M. Kelly. It summarizes her objective of utilizing her billing office experience to resolve insurance claims issues. It also outlines her education, including current study in health information management, and certifications. Finally, it details her extensive work history in medical administrative and coordinator roles, scheduling, billing, and coding for various medical practices and hospitals over the past 20 years.
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Hellen A. Owuor is a licensed pharmacist with over 10 years of experience in retail, clinical, and pharmaceutical research settings. She has a Doctor of Pharmacy degree from Purdue University and is skilled in all aspects of pharmacy management including prescriptions, inventory, regulatory compliance, and customer service. Currently she works as a pharmacy manager for CVS Health where she oversees operations and meets sales targets. Her experience also includes internships in hospital and retail pharmacy settings.
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Joe Saad is an Electrical Engineer and business management consultant who has lived in Canada since 1989. He has over 30 years of experience working for multinational companies like AT&T and IBM. In 2007, Joe embarked on a new career in counseling and received certification in Christian life coaching. He now leads the Holy Family Ministry in Toronto, providing counseling services to individuals, couples, and families.
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Mahin Amouzadeh is seeking a position as a pharmacy technician and has over 15 years of experience in pharmacy, medical administration, and banking. She is bilingual in Farsi and English and holds a B.S. in Management Information Systems as well as several medical and pharmacy certifications. Her resume highlights credentials in areas such as medical terminology, anatomy, and software programs used in pharmacies. She has worked as a pharmacy technician at CVS Pharmacy for over 3 years and has previous internship and work experience in medical administration and radiology assistance.
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Tracy Quella has over 10 years of experience in stockroom and purchasing roles. She currently works as a Stockroom Technician/Purchasing Agent for Adtech Medical Instruments, where her responsibilities include managing raw materials inventory, creating purchase orders, and ensuring production needs are met in a timely manner. Previously, she was a Certified Nursing Assistant and Cardiac Care Technician at Wheaton Franciscan Hospital for over 10 years.
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Melinda Ross has over 18 years of experience as a lead medical coder specializing in outpatient coding. She has certifications in ICD-9 and ICD-10 and experience coding for ambulatory surgery, observations, clinics, and ER charts. She has worked remotely and at hospitals in California and Illinois coding outpatient records and training other coders. Her skills include proficiency with various coding software programs and encoders as well as knowledge of private and commercial insurance carriers.
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Cheri Cavilear has over 15 years of experience in customer service, administration, and healthcare roles. She has worked as a warranty administrator, home healthcare assistant, assistant manager, substitute teacher, phlebotomist, and laboratory technician. Cavilear has strong communication, organization, and time management skills developed through managing teams and daily operations across multiple industries. She has extensive experience with data entry, claims processing, scheduling, and administrative duties. Cavilear has an Associate's degree in Marketing and Management and is proficient in Microsoft Office.
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Patricia Haiby seeks an outpatient or inpatient coding specialist position. She has advanced knowledge of medical coding guidelines and experience coding for outpatient, inpatient, medical surgical, obstetrics, swing bed, wound care and ambulance services. As a current coding specialist, she reviews medical records to ensure coding compliance and assigns accurate diagnosis, procedure and evaluation and management codes. Previously, she held human resources and executive assistant roles managing schedules, employee relations, and compliance. She has an associate degree in health information technology and is a registered health information technician and certified ambulance coder.
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Romona Dillard is seeking a position that allows for growth and advancement. She has over 20 years of experience coordinating patient registration and insurance verification processes. Her skills include proficiency with various hospital systems like RIS, ORMIS, EPIC, and experience with tasks like scheduling, financial collection, and ensuring patient access to clinical services.
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Brooks Binkley is a Certified Pharmacy Technician in Tennessee with over 14 years of experience in compounding and insurance billing. She currently works as a Lab Supervisor and Certified Pharmacy Technician at Professional Arts Pharmacy in Hermitage, TN. Binkley has a high school diploma and is working towards a Liberal Studies BS degree from Middle Tennessee State University. She is proficient in pharmacy terminology and software like Microsoft Office.
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The document is a resume for Deborah Hegedus seeking a position in the medical field utilizing her experience with medical terminology, coding, software, billing and collections. She has qualifications including knowledge of the medical field, communication and computer skills. Her education includes degrees in medical insurance billing and coding from Heald College and De Anza College. Prior experience includes medical billing, data entry and reception work at various medical organizations.
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This document is a resume for Deneen M. Kelly. It summarizes her objective of utilizing her billing office experience to resolve insurance claims issues. It also outlines her education, including current study in health information management, and certifications. Finally, it details her extensive work history in medical administrative and coordinator roles, scheduling, billing, and coding for various medical practices and hospitals over the past 20 years.
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Hellen A. Owuor is a licensed pharmacist with over 10 years of experience in retail, clinical, and pharmaceutical research settings. She has a Doctor of Pharmacy degree from Purdue University and is skilled in all aspects of pharmacy management including prescriptions, inventory, regulatory compliance, and customer service. Currently she works as a pharmacy manager for CVS Health where she oversees operations and meets sales targets. Her experience also includes internships in hospital and retail pharmacy settings.
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Retour d’expérience de la présentation de ce jeudi 04 février 2016 à 'Icam Bretagne dans le cadre du séminaire sur le thème de la communication;
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RAPPEL CONCOURS
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On participe au concours "La Fabrique Aviva" où l'on peut gagner au minimum 2000€ si l'on finit dans les 14 premiers projets de notre catégorie : "Protéger l'environnement"
Merci à tous
Lien : https://lafabrique-france.aviva.com/voting/projet/vue/640
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This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
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Lisa Forbes has over 30 years of experience in clinical research coordination and administration. She has worked extensively on clinical trials and research studies in oncology, hematology, and HIV medicine. Her roles have included coordinating trials, maintaining regulatory compliance, collecting and managing clinical data, and assisting principal investigators. She is proficient in Microsoft Word and has strong communication, organizational, and public relations skills.
BMA Presentation 2011_Handout
B. McLaughlin Associates, Inc. (BMA) has been a provider of customized, cost-effective clinical research support for over 18 years. Our services for drug, biologics, and device studies include Study Management, Regulatory and Financial Document Collection and Review, Regulatory Document Audits, Clinical Study Contract/Patient Budget Negotiation, Informed Consent Creation, Review and Change Management, Drug and Biologics Temperature Monitoring (Cold Chain), Data Management, and Clinical Scientist Support.
We recognize the importance of a successfully run clinical trial and have the industry experienced staff to enhance your study team and create positive results. Our Study Analysts, Data Analysts, and Study Managers will professionally run your projects to ensure timely completion of all contracted tasks, while keeping quality, accountability, and compliance paramount. Whether your outsourcing requirements are for the full life cycle of a clinical trial or just for a specific need, BMA is here to provide a flexible solution.
Our goal is to provide world class support services that keep your projects on time, within budget, and compliant to all regulatory authorities.
Clinical Trial Management
Novum manages clinical endpoint studies that require large patient populations in multiple disease states, treated in an outpatient setting. With a nationwide network of more than 2,000 investigator sites, we ensure that all selected sites meet the requirements of each study and Novum’s high standards.
legal cv
Martha Schmidt has over 20 years of experience in clinical research, drug development, and the medical field. She has worked for several large pharmaceutical companies, managing clinical trials and ensuring regulatory compliance. She is knowledgeable about all phases of drug development and has experience in clinical oncology. Schmidt has extensive expertise in clinical data review and analysis. She is passionate about assisting with product liability and medical malpractice litigation through case review and serving as an expert witness.
Resume_SHF_Nov2016
Stacy H. Flannery has over 15 years of experience in clinical research as an expert study coordinator, clinical trials associate, and clinical research coordinator. She has managed clinical trials through all phases of development across multiple therapeutic areas. She is proficient in various clinical trials databases and systems and ensures compliance with ICH GCP guidelines and regulations.
ROLES AND RESPONSIBILITIES OF sponsor and CRO.pptx
The document discusses the roles and responsibilities of clinical trial sponsors and contract research organizations (CROs). It outlines that sponsors are responsible for initiating, managing, and financing clinical trials in accordance with good clinical practice guidelines. They must select investigators, monitor trials, ensure regulatory approval is obtained, and address safety issues. CROs assist sponsors by providing outsourced clinical research services like monitoring, data management, and regulatory support. Sponsors and CROs have legal contracts defining their responsibilities for conducting research properly and protecting participant safety.
Investigator Initated Trials (IIT)
The Industry funded IIT from the CRO perspective: Optimizing the interface between the industry and the Sponsor- Investigator.
Presented by Ran Frenkel, CEO, Pharma Focus Israel at the First European Investigator Initiated Trials Conference in Barcelona, Spain.
Clinical Research Office Newsletter volume 1 Issue 1
The Clinical Research Office was created as a centralized operations office to assist the faculty investigators at Ponce Research Institute.
Role and Responsiblities of Sponsor as per ICH GCP.pptx
The sponsor is responsible for the overall conduct of the clinical trial according to GCP guidelines. This includes proper trial design, monitoring, data handling, record keeping, reporting safety issues and audit. The sponsor designates appropriate medical and scientific experts to oversee the trial. It also selects and monitors investigators and ensures ethics committee approval and participant consent are obtained. The sponsor manufactures, supplies and handles the investigational product and maintains its quality. It is responsible for reporting adverse events and trial results to regulatory authorities.
Indegene ci capability csl behring
Indegene provides competitive intelligence and analytics solutions for life sciences, payers, and providers to improve health outcomes and business performance. It offers solutions across various areas like risk and quality management, clinical effectiveness, medical solutions, marketing solutions, and population health management. Indegene leverages proprietary medical analytics frameworks, a suite of platforms, global operational expertise, and medical expertise to drive insights. It has over 3,000 employees globally with delivery centers in several countries. Indegene receives recognition from industry analysts for its capabilities in life sciences sales, marketing, and strategic consulting.
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Global Clinical Trials: Best Practices & Common Pitfalls
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Designing of clinical study protocol rumana hameed
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ROLES AND RESPONSIBILITIES OF sponsor and CRO.pptx
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Pentha Research Capabilities
- 1. CompanyProfile PenthaResearchA South Cone Alliance Member
- 2. Full Service CRO Born on the basis of a SMO based in Buenos Aires, Argentina in 2003, PENTHA RESEARCH became later a regional full-service Contract Research Organization (CRO)covering, throughout South Cone Alliance, an operational field in South America and Mexico assisting the biotechnology, pharmaceutical and medical device industries in every activities of preclinical, clinical development (Phase I-IV Clinical Trials) and registration process.
- 3. WhatmakesPenthaResearchdifferent Directly linked with CRO services our R&D department proudly works in on a pipeline of new medical technology offered to investors and sponsors as a plus of opportunities to be developed according to their interests, and needs to explore new scientific horizons.
- 8. ContactInformation: Gerardo M.Uviedo, MD- CEO E-mail: gerardo.uviedo@pentharesearch.com
- 9. PenthaResearchCapabilities Regulatory affairs Study Feasibility Study Start-Up Local Project Coordination Clinical Trial Management Regional Pharmacovigilance QualityAsuranceServices Research & Development
- 10. Study Feasibility Pentha Research process includes: I-Analysis on protocol in order to determine - Best country, PI, site to conduct the trial -Enrolment Projections - Overall costs II- Check up/comparison with historical database of like trial information III- Develop, distribute and assess site feasibility survey IV- Provide patient/site/month recruitment estimates
- 11. Regulatory Affairs Advice on Regulatory procedures in countries of operation Ethicscommitteesubmissions Site Regulatory Files management Management of IRB documents and operations Local and Regional Regulatory Agency approvals Import /Export licenses Custom consultancy and management
- 12. Study Start-Up Study Design, Protocol/CRF development Clinical Development Plans (PM, Monitoring, Quality, Communication, etc) Certified Translation of applicable documents Investigator/site selection & patient recruitment strategies Investigator Meeting Planning and execution Local regulatory documents collection & Management Preparation of country specific product labels Custom consultancy and management
- 13. Local Project Coordination This service provides sponsors/clients with legal representation in Latin America for the conduction of a clinical trial enabling Pentha research to: Execute contracts with PIs, sites & vendors on behalf of the client Administrate PI and vendor grants Represent sponsor at a local/ central EC´s and IRB´s Represent sponsor for importation purposes
- 14. Clinical Trial Management Activities involving Ongoing trial Management: Regulatory package preparation in accordance with country specific requirements Patient screening and randomization Site monitoring Project tracking via e-system Management of Drug supply, laboratories and local couriers Local and central safety management Communication with sites, sponsor and vendor /TLC, FtoF, internal project meetings)
- 16. QualityAsuranceServices Conduct of quality GCP audits Conduct of contract vendor/SUPPLIER AUDITS Conduct internal (staff) and external (sites) GCP training Development of Quality Plans, Quality Manuals, SOPs and SQPs
- 17. EARLY PHASE DEVELOPMENT DIVISION Itconsists of a exclusive 4 bedsuitlocated in one of ourbranches (Argentina) speciallyequipedtodevelopeearlyphasetrials (First in Human/IIa), combinedwith a highcomplexityfacility (Denton CooleySanatorium-BsAs) meetingalltherequirementsneededforsuccessfulexecution of thesestudies.
- 18. Research & Development Design of new medicaltechnology Set Up of preclinicalstudies Data Processing and Statistics