March 12, 2012
International Real World Post-marketing Studies that Involve Patient Intervention

International Real World Post-marketing Studies that Involve Patient Intervention

There is an increasing demand for real world information from pharmaceutical payers and international regulatory agencies.

Generally these studies only collect data available as part of routine clinical practice. However, the sponsors of these studies can gain substantial additional information on their patients in a real world setting by collecting additional data from patients including quality of life, patient satisfaction and other patient reported outcomes. In addition, with the increasing advance of gene testing in therapy choice, sponsors may also benefit from collection and storage of biological material from patients.

What you will learn:

Setting up and running international real-world observational studies with:
    - Direct to patient data collection
    - Collection of blood/tissue/other body fluids – use in study and storage for future use

Medical directors, medical affairs, drug safety, epidemiologists, individuals involved in the commercialisation and/or marketing of new drugs

Dr. Carl de Moor, Vice President Epidemiology, North America, REGISTRAT-MAPI  

Dr. de Moor brings a wealth of Medical Research and clinical research organization (CRO) experience in the areas of epidemiology, biostatistics, & health outcomes. He collectively has 24 year of experience in consulting and research in epidemiology, biostatistics, and health outcomes including retrospective and prospective observational studies, secondary database analyses, clinical and patient reported outcomes studies, economic analysis, and design of registries. He also has extensive experience in the design of Phase I-IV clinical trials.

Beginning his career as a Research Assistant Professor at the University of Texas Health Science Center, Carl has served as Chief, Behavioral Statistics & Associate Professor of Biostatistics at the University of Texas M. D. Anderson Cancer Center; Associate Director of Design & Analysis and Associate Professor, Division of Biostatistics at the University of Texas Health Science Center at Houston, School of Public Health; Director, Data Management Core, Clinical Research Program, Children's Hospital Boston and Associate Professor, Department of Psychiatry, Harvard Medical School.

Most recently, he served as Executive Director, Epidemiology & Health Outcomes at PPD where he was responsible for pharmacoepidemiology, safety registries, health outcomes, and pharmacoeconomic consulting and studies in the late stage research. Prior to this position he was Vice President Health Outcomes and Pharmacoeconomics for Supportive Oncology Services, Inc. in Memphis, responsible for direction of all health outcomes, pharmacoeconomic, and pharmacoepidemiology post marketing observational studies.

Dr. de Moor has been published in more than 95 peer-reviewed publications in clinical, epidemiological and health outcomes studies, has served as biostatistician co-investigator and co-principal investigator on 40 funded grants and contracts, and performed article reviews for 12 industry publications. He has performed grant review committee service for the NIH, Lance Armstrong Foundation, California Tobacco Control Initiative, CDC, and American Cancer Society. He received his PhD and MS in Biostatistics from the University of Washington and a BS in Biology from San Diego State University.

Sarah Rosen, Global Project Director,  REGISTRAT-MAPI 

Sarah joined MAPI in April 2006 where she worked as an International Project Manager for observational studies managing several studies implemented in 1 to 11 countries in various disease areas including endocrinology, respiratory, oncology and sexual health.

Sarah then became Project Director in January 2008. Since then, she has supervised a number of international studies and has also been significantly involved in proposal development and strategy building for potential clients. Studies managed as a Project Director have included studies in depression, oncology, vaccines, genetic diseases and endocrinology.

After two years of Human Genetics at the University of Nottingham (UK), Sarah continued her genetic studies at the University of Lyon before reading a European Diploma in Pharmaceutical Medicine (masters degree in clinical research).

Sarah then went on to work with the French National Comprehensive Centres Guidelines Department in the European team. As well as organising the 3rd Guidelines International Network conference in Lyon which gathered more than 300 International experts, Sarah worked on a French-Canadian project on the adaptation of guidelines and then on a European FP6 Coordination Action Project whose aim was to coordinate the elaboration of cancer guidelines throughout Europe.

REGISTRAT-MAPI provides strategic and operational solutions for our clients in the design and implementation of Late Phase studies. We are the pharmaceutical industry’s largest global CRO dedicated exclusively to real world clinical research. With more than 250 experienced professionals, we have served the biopharmaceutical and medical device industries for more than 20 years.

REGISTRAT-MAPI is an established leader in navigating the complex and evolving landscape of global Late Phase research. With offices in Europe, North America, and Asia, we guide our clients through strategic and practical issues from project conceptualization and design, to global execution in the real world.

REGISTRAT-MAPI experts are your direct link to the latest views and solutions associated with Late Phase research. Most importantly, our expertise is honed from hands-on involvement in the practical challenges of designing and managing Late Phase research.