Clinical
Regulatory Writing

Acumen’s experience and unwavering commitment to scientific integrity distinguishes us as an industry leader in the preparation of highest quality clinical regulatory documents.  We provide industry-leading writing services, from protocols to clinical study reports, briefing documents to NDA/BLA submissions.

“Acumen writers became valued members of the team from day one; providing full service planning and writing support. Acumen always delivered in line with the agreed and often aggressive timelines, while demonstrating tremendous patience and agility when asked to pivot rapidly when strategic direction changed. They produced high-quality documents that contributed to a successful accelerated BLA and subsequent full approval.”
— Jenny Eaddy, Executive Director, Regulatory Affairs

PARTNER FOR SUCCESS

Consistent, dependable, best-in-class, timely document delivery which meet your goals.

Our team of clinical writers integrate their experience and application of best practices for document development with the goals and expectations of the team.

Acumen writers work to help unburden the Sponsor team and fill the gaps where internal support may be lacking. We embrace projects that challenge and engage our team and, by being selective with our partnerships, we maximize our commitment to high-quality document creation.

As strategic partners, we offer comprehensive writing support that goes a step beyond other CRO writing firms. Our goal is to seamlessly integrate with our client teams, helping drive their documents forward with clarity, precision, and efficiency. With Acumen, your projects are in capable hands, guided by a deep understanding of drug development and the regulatory landscape.

35+

Clinical Writers

2,000+

Clinical
Documents Written

80+

Sponsors for Clinical Writing

300+

Clinical
Documents Written per Year

We Stand Out From The Crowd

What sets Acumen apart from the rest?

Acumen offers unparalleled expertise in clinical regulatory writing, catering to biopharmaceutical companies of all sizes and programs in all stages of development. Our deeply experienced writers equipped with industry-leading processes and software solutions allow Acumen to meet the unique challenges of document development, ensuring our deliverables are on time and meet regulatory compliance.

We are committed to delivering comprehensive medical writing services, handling everything from outlines to pre-publishing, there is no step of the document development process we can’t assist with. Our writers are adept at coordinating content development, establishing timelines, managing review cycles and round tables, and integrating edits, and ensuring Quality Control review has been performed.

We swiftly scale up our team as demands evolve, utilizing additional writers or other specific skills and experience needed to meet timelines and get cost-effective results.

Supporting All Your Documents

  • NDA and BLA Submissions: all clinical summary modules (M2.5, M2.7 summaries, general investigational plan, M5, Safety Updates)

  • Clinical Study Reports (synoptic CSRs, abbreviated CSRs, full CSRs, addendums)

  • Patient Safety Narratives

  • Clinical Study Protocols (all phases)

  • Protocols Amendments

  • ICFs

  • De novo Investigator Brochures

  • Investigator Brochure Updates

  • Safety Reports (eg, DSURs, PBRERs)

  • Annual Reports

  • Briefing Books

  • Special Regulatory Designation Applications (FT, BTD, ODD)

  • Regulatory Responses

  • Summary of Changes

  • Pharmacy Manuals

It Takes a Village

Collaboration is at the heart of our approach to clinical regulatory writing. Our writers work seamlessly within a cohesive team that offers a spectrum of complementary services.

These experts include:

Efficiency Through Technology

We empower our clinical writing team with our proprietary medical writing software, Acumen’s Smart Document Solution, built specifically to provide the right tools for efficient and consistent document development.