Premium Medical Writing Services

Clinical Study Writing

Accurate, well-structured clinical study documents are essential for regulatory approval and successful study execution.
Our expert writers ensure your protocols and reports are clear, compliant, and tailored to meet regulatory requirements.

Study Protocols & Reports

Submission-ready, ICH-compliant protocols and reports for all study phases. Ensure your study documents meet regulatory expectations with our expert guidance.

Patient Narratives

Clear and concise summaries tailored to regulatory requirements. We help you communicate patient data effectively and compliantly.

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Regulatory & Development Documents

Navigating regulatory requirements can be complex, but with Bioforum’s expertise, your documentation will be meticulously prepared to meet FDA, EMA, and ICH standards, ensuring smooth submission and approval.

Briefing Packages

Expertly crafted documents for regulatory meetings. Make a strong impression with well-structured, compelling content.

Investigator’s Brochures

Comprehensive study and product information. Keep investigators informed with high-quality, detailed brochures.

Data Safety Update Reports (DSURs)

Ensure compliance and safety monitoring. Maintain regulatory compliance and demonstrate patient safety effectively.

Common Technical Document (CTD) Summaries

Structured summaries for regulatory submissions. Get your data submission-ready with precise, high-quality documentation.

Integrated Summaries (ISS/ISE)

Clear and concise safety and efficacy reports. Strengthen your regulatory submissions with expertly written summaries.

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Medical Communication

Effective communication is key to scientific success.

Our medical writing team helps you present your findings clearly and professionally, whether for journal publication, conferences, or stakeholder engagement.

Journal Articles

Writing and editing support, from de novo drafting to final submission. Share your research effectively with expertly crafted articles.

Medical Presentations & Posters

Professional slide decks, abstracts, and poster content. Deliver impactful presentations with clear,  concise materials

Publication Strategy

Assistance with journal selection and submission planning. Maximize your publication success with  strategic guidance.

Quality Control

Precision and compliance are non-negotiable in regulatory submissions. Bioforum provides rigorous quality control to ensure your documents meet the highest industry standards.

QC for Regulatory Documents

Thorough quality checks to ensure accuracy and compliance. Avoid costly errors with our rigorous quality control processes.

Training Services

Empower your team with the knowledge and skills to excel in medical writing and regulatory documentation. Our tailored training programs provide hands-on experience and best practices to enhance expertise.

Regulatory & Clinical Writing Training

Tailored workshops for researchers and industry professionals. Build your team’s expertise with customized training.

Protocol Development Courses

Hands-on guidance on writing study protocols. Strengthen your protocol development process with expert-led training.

Why Choose Bioforum?

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Doctorate-Level Experts

Highly experienced writers across diverse therapeutic areas. Work with professionals who understand your industry’s unique challenges.

End-to-End Support

From study protocols to final regulatory submissions. Simplify your clinical trial documentation with our full-spectrum support.

Regulatory Excellence

Proven success in FDA and EMA submissions. Trust a team with a track record of regulatory approval success.

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Discover how Bioforum can enhance your medical writing needs.

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Frequently Asked Questions

In what therapeutic areas does your medical writing team have experience?

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.

What is your typical turnover time for a clinical study report/clinical study protocol/journal article?

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.

What is the average price for writing a clinical study protocol/report/journal article?

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.