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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
Frequently Asked Questions

Our medical writers have experience in a wide variety of therapeutic areas including Neurology, Oncology, Infectious Diseases, Immunology, Genetics, Computational Biology/Bioinformatics, Pharmacology, Hematology, Drug Development, (AI-based) Medical Devices and Molecular Diagnostics.

The amount of time to complete a writing project varies significantly between projects. The complexity of the studies and the development program are the primary factors in determining the time to completion of a writing project. A few additional factors are the amount of literature searching that is required (i.e., if the Sponsor can provide a literature collection, this would be a good way to accelerate the writing process), the clarity of messaging (i.e., the clearer we are on expectations at the outset, the faster we can write) and availability of reviewers to provide input on the delivered drafts. We discuss the timeline in the kickoff meeting and assign two writers per project, to increase writer availability and allow for concurrent work, where applicable.

We prepare a unique proposal for each project. Our unit of pricing is hour of work and our basic process comprises a shell document, three full drafts, quality checking and publishing. The effort estimation includes internal review and oversight by a team leader. We also offer a timed contract model, in which a writer is fully dedicated to a client and can work on multiple projects. This model is offered on a full- or half-time employee (FTE) basis, for 3-, 6- or 12-month contracts. This model also includes support from MW team leaders.

Our core Services
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