Learn about Medpace's real world evidence and late phase research capabilities.

Therapeutically specialized clinical development REAL WORLD EVIDENCE AND LATE PHASE RESEARCH Discover the POWER OF X ® Experts. Experience. Execution.
Therapeutically specialized clinical development  REAL WORLD EVIDENCE AND LATE PHASE RESEARCH  Discover the POWER OF X    ...
A DEEPER DIVE INTO REAL WORLD EVIDENCE AND LATE PHASE RESEARCH Experts, Experience, and Execution in real world and late phase research combine into a powerful advantage for our Sponsors. Medpace supports our sponsors who are trying to bridge the gap from development to commercialization by providing specialized expertise in the design and conduct of real world and late phase research studies. We have assembled a team of medical, operational, eClinical, epidemiologic, and regulatory experts with extensive experience designing and conducting real world evidence and late phase research studies. Our global operational reach and full-service capabilities for clinical and observational research can help you achieve your scientific and commercial objectives. As a scientifically-driven, global, full-service clinical contract research organization (CRO), Medpace helps accelerate the global development of safe and effective medical therapeutics through its physician-led, high-science, and disciplined operating approach that leverages local regulatory and deep therapeutic expertise. Plan Early for Late Phase As the market access landscape continues to evolve, the timing of real world and late phase research is becoming increasingly important. Drawing upon our experience and expertise, Medpace can help you determine the best timing for initiating earlier analyses and planning for later phase, post-marketing analysis. Whether it be earlier or later in the development cycle, Medpace can generate real world evidence through the design and execution of prospective and retrospective observational studies, registries, safety studies, and expanded access programs. In addition, Medpace has the capability to conduct standalone or piggyback economic analyses, including cost-minimization analysis, cost-effectiveness/cost-utility analysis, and budget impact modeling. 2
A DEEPER DIVE INTO REAL WORLD EVIDENCE AND LATE PHASE RESEARCH Experts, Experience, and Execution in real world and late p...
The Power of EXPERTS MEDICAL OPERATIONAL eCLINICAL EPIDEMIOLOGY A highly qualified team of executives and specialists lead our real world evidence and late phase research efforts. With over 100 years of combined clinical research experience, including 50 years dedicated exclusively to real world and late phase research, this team is recognized for its expertise and leadership. MEDICAL Scientific and Medical Leadership Jon Isaacsohn, MD Executive Vice President, Senior Advisor to Real World Evidence and Late Phase Research Dr. Jon Isaacsohn is a board-certified cardiologist with more than 25 years of experience in clinical medicine and drug development of multiple product candidates, including oversight of the design and execution of dozens of post marketing studies. Experience Summary • Extensive experience in protocol design and execution of multi-center, global clinical trials through to submissions of marketing applications to different regulatory authorities • Former Chief Medical Officer at a large pharmaceutical company where he provided medical perspective and input on business development efforts, pharmacovigilance, global health initiatives, and new therapeutic entity development Education Summary • Doctor of Medicine, University of Cape Town Medical School • Research Fellow, Cardiology, Brockton/West Roxbury Veterans Administration Medical Center • Residency in Pediatrics, University of Tel Aviv, Sackler School of Medicine • Residency in Internal Medicine, Brigham and Women’s Hospital, Harvard Medical School • Research Fellow, Department of Nuclear Medicine, Massachusetts General Hospital Glynis Neagle, MD Vice President, Medical Affairs Dr. Glynis Neagle is a physician with over 20 years of experience working on Phase I-IV clinical trials as well as observational late phase studies. Experience Summary • Has held senior positions including Chief Medical Officer in medical affairs and clinical development for both pharmaceutical companies and CROs • Extensive therapeutic expertise in Oncology, Metabolic/Endocrine and Immunotherapy • Has participated in a variety of scientific advisory boards, presented at international meetings, and provided crucial expert opinion on global drug development strategy Education Summary • Bachelor of Science, Biochemistry and Immunology, University of Glasgow • Doctor of Medicine, University of Glasgow 3
The Power of EXPERTS MEDICAL  OPERATIONAL  eCLINICAL  EPIDEMIOLOGY  A highly qualified team of executives and specialists ...
OPERATIONAL Operational Leadership Derenda Nichols, BS Director, Real World Evidence and Late Phase Clinical Operations Derenda Nichols has more than 24 years of experience in the CRO industry, including 13 years in post-marketing and periapproval research Experience Summary • Extensive experience in monitoring and site management, direct-to-patient studies, regulatory affairs, medical writing, global project management, operations, and executive management • Has participated in the successful planning and execution of large, multi-country projects, leading both domestic and global teams in a variety of therapeutics • Previously Head of Global Operations for a niche, late-phase CRO Education Summary • Bachelor of Science, Business Administration, Elmhurst College eCLINICAL eClinical/Technology Leadership Lee Walke, MS, MIS Vice President, eClinical and Real World Evidence and Late Phase Research Lee Walke has over 25 years of experience in clinical research and has been involved in late phase research for nearly 10 years. He has been a leader in applying technology and common-sense solutions to complex problems in clinical research, with a focus on data collection, analysis, and reporting as well as developing and deploying technologies to facilitate real world and late phase research. Experience Summary • Currently serving as the co-chair of the Cost Benefit Committee for the US Food & Drug Administration/ Clinical Data Interchange Standards Consortium eSource Stakeholders Group • Early adopter and thought leader in Data Science for clinical research, emphasizing data standards and data integration practices for new drug applications • Head of US biometrics for a top 10 CRO • Led enterprise software development and implementation projects, including eTMF systems, EDC, Regulatory Publishing, and CTMS Education Summary • Bachelor of Arts, Psychology, University of Virginia • Master of Science, Management Information Systems, University of Virginia • Master of Science, Management Information Systems, University of Virginia 4
OPERATIONAL  Operational Leadership  Derenda Nichols, BS  Director, Real World Evidence and Late Phase Clinical Operations...

 

EPIDEMIOLOGY Observational Epidemiology and Health Economics Leadership Matthew J. Page, PhD, MPP Epidemiologist and Health Economist, Real World Evidence and Late Phase Research Dr. Matt Page has over 12 years of experience working with companies to implement numerous observational epidemiologic and pharmacoeconomic methodologies. Experience Summary • Experienced health economics researcher, having developed multiple cost-effectiveness and budget impact models • Previous Assistant Professor of Public Health at the College of Charleston, focusing on epidemiology and biostatistics • Work in asthma, cardiovascular disease, community-acquired pneumonia, deep vein thrombosis/pulmonary embolism, diabetes and diabetic foot ulcer, HIV, influenza, invasive pnemococcal diease, metabolic syndrome, migraine and severe headache, and oncology Education Summary • Bachelor of Arts, History, University of Michigan • Master of Public Policy, College of William & Mary • Doctor of Philosophy, Epidemiology, Emory University 5
EPIDEMIOLOGY  Observational Epidemiology and Health Economics Leadership  Matthew J. Page, PhD, MPP  Epidemiologist and He...
The Power of EXPERIENCE Medpace has conducted over 130 real world and late phase studies, involving 40,000 patients at 2,000 sites globally. Medpace has conducted both interventional and non-interventional real world evidence and late phase research studies. These studies included late phase randomized trials (IIIb and IV)), postauthorization safety studies, registries, observational epidemiologic studies, expanded access programs, health economics and outcomes research, and competitive marketing claims studies. 40 , 00 0 CASE STUDIES Medpace and the Real World Evidence and Late Phase Research team brings a broad range of experience to your trials. Click on any of the icons below for case studies that highlight relevant experience and expertise.   6 1 30 HEMATOLOGY/ ONCOLOGY HEMATOLOGY/ ONCOLOGY WOMEN’S HEALTH AUTOIMMUNE AND EPIDEMIOLOGY 2, 00 0
The Power of EXPERIENCE Medpace has conducted over 130 real world and late phase studies, involving 40,000 patients at 2,0...
The Power of EXECUTION Medpace demonstrates a commitment to conducting full-service studies in an exacting manner to produce the highest quality results. Well-defined processes are critical for the successful execution of real world and late phase research. Medpace’s processes demonstrate clearly, and with appropriate detail, the differences between late phase and early phase research, including: • Observational study design and protocol development • Developing formal risk assessments • Executing risk based monitoring • eCRF development for observational research • Collecting patient reported outcomes and patient-sourced data • Long-term data governance • Analysis considerations • Programming best practices for real world and late phase research Technology A critical component to the success of real world and late phase research is the underlying technology. Medpace has enhanced its time-tested, proprietary ClinTrak® Electronic Data Collection (EDC) system to address the challenges specific to real world and late phase research. ClinTrak rwEDC enables electronic data collection, data cleaning, and delivery of data and reports to stakeholders. The ePRO/eDiary component of ClinTrak rwEDC —Research VIA Me®—makes it simple for patients to enter data and helps keep them engaged over long study durations. The enhanced platform: • Reduces the burden of participation by clinical sites • Enables patients to contribute data to the system • Interfaces with multiple sources of external data • Provides value-added data and reports to Sponsors • Operates over long periods of time with high volumes of data and numbers of users Learn more about: About Medpace Medpace is a scientifically-driven, global, full-service clinical CRO providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its physician-led, high-science, and disciplined operating approach that leverages local regulatory analytic, operational, and therapeutic expertise. RWE and Late Phase Research – Medpace provides comprehensive services to support your post-approval strategies and to conduct pre-and-post-approval real world and late phase studies in biotech, pharma, and device areas. Our specialized teams provide strategic leadership and operational excellence to help you achieve your scientific and commercial objectives. 7
The Power of EXECUTION Medpace demonstrates a commitment to conducting full-service studies in an exacting manner to produ...