Bioforum is an international Biometrics focused CRO assisting companies to undertake clinical studies and collect, clean, integrate, and statistically analyse and report all data for submission to the US and European regulators, FDA and EMA, in compliance with regulatory data conventions (CDISC).
We assist Sponsors engaging with the FDA for study design, project Optimus, data integration and study pooling strategies so that Bioforum's biostatisticians can prepare the mandatory Integrated Summaries of Safety and Efficacy (ISS/ISE).
We prepare IBs, Protocols, EDC Databases, Tables/Listings/ Figures, Statistical Analyses, and Clinical Study Reports in close collaboration with the Sponsor’s representatives.
We often act as the central data centre for pivotal phase 2 and 3 international studies so that the Sponsor can gain efficiencies in time and money through reuse of database components and analysis programs across studies while in parallel Bioforum prepares the integrated cross-study data repository required for preparing the ISS/ISE for submission to the FDA.
We offer realtime project status access and clinical study data dashboards and analytics for Project Managers, Medical Monitors, Data Managers, Statisticians, DMCs, DMSBs, and other stakeholders via BioGRID.
Why work with us
As a long-time international specialist in biostatistics, statistical programming, clinical data management, and medical writing, Bioforum's technical and (FDA/EMA) regulatory expertise ensure a first-time right approach to clinical study design, DB design and data capture, statistical analysis and reporting at (1) study level (CSR/TFLS), and at (2) NDA/BLA level (ISS/ISE & Data Submission packages).
Bioforum deploys software tools that automate processes (speed) and provide Sponsors with real-time analytical insights into the study data (transparency).
Please also download the recent white paper by Frost & Sullivan entitled “Faster Time to Market: Approaches to Biometrics for Emerging Biopharma Companies”. The paper addresses outsourcing strategies and trends such as:
🔹 The evolving role of biometrics in modern clinical trials
🔹 Key challenges faced by emergent biopharma companies, including decentralized trials and adaptive trial designs
🔹 Why companies are opting for biometrics-focused CROs instead of full-service providers
🔹 Best practices for ensuring regulatory compliance and optimizing data workflows
