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Turning Challenges into Success Stories

Rescue Studies

Why Bioforum for Rescue Studies?

At Bioforum, we specialize in rescue studies, providing sponsors with expert-driven solutions to recover and optimize struggling clinical trials.
Whether facing data quality issues, regulatory concerns, timeline delays, or vendor underperformance, our team steps in to assess challenges, implement corrective actions, and ensure seamless execution. Rescue studies address critical setbacks such as poor data integrity, compliance risks, and operational failures, helping trials realign with objectives, meet regulatory expectations, and stay on track for success.

Proven Track Record

Successfully rescued and optimized multiple clinical trials across various 
therapeutic areas.

Rapid Deployment

Immediate assessment and integration of corrective actions to minimize disruption.

Technology-Driven Approach

Seamless integration with existing platforms and various technologies

Cross-Functional Expertise

A multidisciplinary team of experts to address all aspects of study challenges.

Success in Action

We have partnered with sponsors to successfully recover and realign studies at various phases, preventing costly delays and ensuring regulatory approval readiness. Our approach prioritizes data-driven decision-making, proactive risk management, and sponsor collaboration to turn struggling trials into successful outcomes.

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.

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