Janet Boyle
Co-founder and Compliance Officer
BA Biology/Health & Human Development; Lehigh University
MS Clinical Research Organization & Management; Drexel University College of Medicine
3 years experience in Merck Manufacturing Division: Biological Quality Control Inspector and Supervisor, Environmental Compliance
10 years experience with BCH and 18 years experience at Merck in Phase I-III Clinical Research including all aspects of study conduct, regulatory document writing (protocols, IBs, CSRs), data review/management, and regulatory filing activities including Integrated Summaries of Safety & Efficacy. Contributed to multiple drug development programs in several therapeutic areas.
Personnel and program management resource allocation for Early Clinical Research portfolio (200+ studies), program-wide CSR and WMA planning and tracking. Initiative leader and contributor for large pharma merger roles and operations and process harmonization teams.
Michele Hyman
Co-founder and Operations Officer
BS Pharmacy/University of the Sciences Philadelphia
9 years experience in GMP, marketed and research material; manufacturing, packaging, and global clinical supplies coordination
2 years experience in clinical research process, training, and personnel development as a clinical learning development specialist
10 years experience with BCH and 14 years experience at Merck in Early Phase Clinical Research including:
Protocol authoring and all aspects of study conduct and site coordination, regulatory document writing, data management, report writing, and filing activities -contributing to multiple drug development programs in several therapeutic areas.
Personnel and program management, resource allocation for large early clinical research portfolio.
Initiative leader and contributor to departmental company merger teams and leader for the departmental Training, Development, and Curriculum Team, as well as, multiple process and system development teams.