GCP-MB
Global Consulting Partners in Medical Biometrics
GCP-MB Principals
Mark H. Bradshaw, Ph.D.
After earning his Ph.D. in Biometrics and Psychometrics from the Johns Hopkins University in 1979, Dr. Bradshaw began his pharmaceutical development career at Glaxo managing statisticians, SAS programmers and data managers in clinical drug development. He subsequently managed the same functional areas for Syntex (acquired by Roche), adding IT responsibilities as well, and later with Fidia Pharmaceuticals. Dr. Bradshaw also managed the first successful global EDC company with offices in Europe and US.
For the past 15+ years Dr. Bradshaw has consulted extensively with small pharma and biotech companies in statistical and data management areas, assisted in develop planning and protocol design, and personally represented sponsors at FDA and EMEA meetings. During that period he held clinical trial executive roles in three of the largest global CROs (PPD, ICON and Covance), leading Clinical Operations groups in 15 countries, providing clinical development services along with IT support and clinical trial software. He has worked and lived for extended periods in UK, Europe and Asia, and has developed data management and clinical monitoring partnerships with clinical trial service companies in US, Europe, India, Singapore and Australia.
Dr. Bradshaw is now working through Global Consulting Partners in Medical Biometrics, LLC supporting clinical development involving local and global clinical trials. GCP-MB collaborates with small pharma and biotech companies and investment groups, providing strategic consulting and managing statistical and clinical data projects. GCP-MB employs data management and statistical analysis teams in the US, Europe and India.
David Shepherd
As a founder member of Efficacy.ch (Basel, Switzerland), David can look back on more than 20 years in software applications development and global systems management. He has specialized in the area of Clinical Data Management since 1998 and has led development efforts for various companies, including CCS Hamburg, ICR GmbH, SIS-SEAC Konstanz, Vermillion Technologies. He has provided custom clinical software solutions to leading companies, such as Covance, Rhône-Poulenc and Astra-Zeneca.
David has extensive experience implementing and managing systems for EDC, RDE, CDISC-Mapping, Global CRF Entry and Document Management, automatic forms processing and workflow. He currently hosts a number of global database systems used in early phase clinical studies.
The TrialDriver Data Management system was developed by David’s group in close cooperation with leading pharma companies and global CROs, ensuring that the system is closely aligned with the demands of clients and the industry in general.
GCP-MB is based in New York City with offices in Konstanz (Germany) and Chandigarh (India)