Clinical Trial Protocol
Protocol Development: Our staff has experience with all aspects of protocol preparation, from developing the initial study design to writing the protocol from a study outline provided by the client. Our experience includes protocol writing for Phase I-IV clinical studies, adult and pediatric indications, orphan indications, and other indications for which there is very little prior knowledge or experience in terms of study design. We have also experienced in Registry and Natural History Protocol Development.
Medical Consulting: Our physicians have extensive experience in drug development and provide medical input on protocols, review clinical study reports, SAE narratives, updating of Investigator’s Brochure, evaluation of Clinical Data, Medical Services for Regulatory Submission and interaction with a counterpart medical experts within regulatory agencies.
Medical Affairs: As your drug products advance in clinical testing, BBCR medical affairs group interfaces with the Clinical Research Unit and investigative sites, and collect and analyzes information on drug experience and safety, and distributes accurate medical information.
Other Services: Besides the services mentioned above, we also offer services in the following areas:
Medical Monitoring
Evaluation of Clinical Data
Clinical Study Report
Writing and Updating of Investigator’s Brochure
Medical Services for Regulatory Submission
Represent the Client at Regulatory Agency Meetings
BBCR role can begin in the pre-clinical stage or at any period in the drug development continuum.