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Guiding Your Trials to Success

Expert led solutions

Statistical Design & Development

Strategic, Data-Driven Trial Design from Day One. Well-designed clinical trials are the foundation of successful clinical development. At Bioforum, we help sponsors create robust, efficient trial strategies that drive smarter Go/No-Go decisions and reduce risk. Our Services Include:

Trial, Program & Portfolio Design

Custom strategies aligned with your development goals

Protocol Development

From synopsis creation to full protocol drafting

Sample Size Calculations

For traditional, adaptive, and Bayesian designs

Regulatory Biostatistics Support

Strategic input for FDA/EMA meetings and submissions

Data / Project Oversight

Total Visibility, Seamless Execution, Trusted Governance
Successful trials rely on real-time data oversight and streamlined project coordination. Bioforum ensures data integrity, regulatory compliance, and performance monitoring from start to finish.

Medical Monitoring

Protecting Patients, Ensuring Compliance, Enabling Success
Our medical monitoring team brings deep therapeutic knowledge and hands-on experience across drug, device, and combination studies. We partner closely with cross-functional teams to maintain scientific integrity and patient safety.

Risk-Based Quality Management (RBQM)

Smarter Oversight. Stronger Data. Higher Efficiency.
Bioforum integrates RBQM principles to focus on Critical to Quality (CtQ) factors, elevate trial oversight, and safeguard data integrity.

Focus on Critical to Quality (CTQ) Factors

Identify essential data elements and allocate resources to what matters most (e.g., primary endpoints, safety data).

Risk Assessment & Mitigation

Systematically assess potential risks before and during the trial, prioritize, implement proactive mitigation strategies to prevent or reduce risks.

Adaptive Oversight

Use data analytics for real-time risk detection, strategies evolve as the trial progresses, based on emerging risks.

Why Choose Bioforum?

Integrated Services
Seamless collaboration across biostatistics, data management, medical monitoring, and quality oversight
Experienced Teams
Senior experts with decades of hands-on experience and regulatory-facing success
Data-Driven Approach
Advanced analytics and strategic insights that drive faster, smarter decision-making
Learn more about our services