KCRI-employed and KCRI-affiliated physicians are both experienced practitioners and seasoned clinical researchers. Thus they combine current clinical knowledge, good understanding of clinical research methodologies as well as regulatory requirements and guidelines. They are specialists in internal medicine, cardiology, pulmonology, radiology, obstetrics & gynecology, clinical biochemistry etc.
Our Physicians provide overall guidance on clinical strategy, particularly for early programs, and design the specific clinical studies geared toward client milestones. Once the study is underway, they provide medical review of critical trial documents (protocol, Investigator Brochure, Case Report Forms), assist sites with protocol related issues and safety reporting, and perform medical monitoring.
They also participate in CECs and DSMBs, provide critical review of trial data and the Clinical Study Reports, generate manuscripts if agreed by the client, and loan their experitse and perspective as Key Opinion Leaders for business development (due diligence) and interactions with regulatory authorities.