The clinical trial protocol governs all aspects of trial execution at the clinical site. A well-designed and clearly written protocol is crucial to ensuring that the critical elements of the trial are communicated to investigators and study staff, the IRB/EC, and regulatory authorities.
Protocol development requires an expert, cross-functional, collaborative team. PROMETRIKA’s medical writers, biostatisticians, and clinical operation staff form highly expert, innovative, and nimble protocol development teams that help sponsors attain scientific and logistical excellence in the design of their phase 1 to phase 4 protocols.
PROMETRIKA’s biostatistical staff includes 5 PhD statisticians, with an average of 25 years’ experience in the biopharmaceutical industry, along with an experienced team of 10 Masters level statisticians. Our statisticians provide sample size estimation, study design consultation and simulations, and robust statistical sections of protocols. In addition to traditional clinical trial designs, our statisticians provide the highly specialized consultation required to guide sponsors through the development of protocols for trials with adaptive designs.
Concise background information and clear procedural instructions help ensure that accurate and consistent patient data are collected by clinical site staff and clinical research associates (CRAs). PROMETRIKA’s medical writing team has an average of 25 years of biopharmaceutical regulatory writing experience in phase 1 through phase 4 protocol development. Our medical writers leverage the requisite sponsor-provided background information to develop comprehensive protocols in compliance with ICH and regulatory authority requirements.
PROMETRIKA’s experienced clinical operations and data management professionals review and contribute to protocol design. Leadership in clinical operations have more than 20 years’ experience and manage a team of specialized regional CRAs with an average of 16 years’ experience. PROMETRIKA’s robust data management department consists of leadership with more than 25 years of experience, 11 data managers with an average of 15 years’ experience and 3 database programmers with an average of 13 years’ experience.
A rigorous protocol that will result in high-quality data for the sponsor’s clinical program requires scientific, medical, and regulatory contributions. PROMETRIKA’s leading professionals work with sponsors’ experts, or with principal consultants with whom we have long-standing relationships, to assure a protocol that is clinically feasible and collects meaningful data that address protocol objectives.