• Clinical Research Organisation
• Contract Research Service

Bioforum – The Data Masters, is an international, tech driven, and data focused CRO, with a track record in Clinical Data Management, Biostatistics, Statistical Programming, and Medical Writing (Biometrics).

We provide Biometrics services at Clinical Study level (EDC DBs, TFLs, Statistical Analysis, CSRs, etc.), and at regulatory submission level (NDA/BLA/MAA). We offer real-time project status and data insights, that translate to business benefits for sponsors in terms of speed, costs, and superior quality of work.

We have extensive experience in preparing the Integrated Summaries of Safety and Efficacy (ISS/ISE) as part of NDAs/BLAs and interacting with the FDA. In addition, our Medical Writing team has extensive experience in creating the Clinical, Non-Clinical and CMC sections of eCTD submissions. Please visit our website for case studies, papers, and webinars, on accelerating FDA submissions, rescuing studies, automating SDTM, and more.

Finally, we can assist in organizing your entire study end-to-end with our clinical and regulatory partners in various parts of the world including USA, Europe and Australia.