Bringing data to life
Acumen provides unsurpassed writing and clinical development services to the biopharmaceutical industry.
Science is hard. Building documents should be easy.
Acumen’s Smart Document Solution allows your team to write, review, and submit pristine regulatory documents faster and more efficiently.
About Acumen
Acumen integrates a wealth of clinical development and medical writing experience with innovative and strategic thinking to provide unsurpassed documentation services to the biopharmaceutical industry.
What Our Customers Are Saying
- NDA DEVELOPMENT -
“Acumen has always delivered high quality documents against tight budgets and timelines. Acumen’s guidance on the interpretation and presentation of key data have helped make our submissions successful. They integrated seamlessly with our internal teams, provided options to increase efficiency, and were always quick to respond to our requests.”
John McCartney PhD,
Vice President of Medical Writing
- MEDICAL CONSULTING -
“The Acumen team brought deep scientific, clinical, and regulatory expertise that proved critical, far more than a typical CRO. When a last-minute toxicology finding arose, the Acumen team worked to keep the submission on track. Alongside the writers, Dr. Virginia Kelly brought her oncology expertise to the protocol, development of the risk-benefit profile, and database construction.”
Yu Liu, MD, PhD, MBA
Chief Medical Officer
- SUBMISSION MANAGEMENT -
“Working with a small biotech company, we chose Acumen to help us with all aspects of IND preparation and submission. It was their attention to detail, from coordinating the resources and milestones, to the writing of the IND modules and ensuring the IND was suitable for regulatory submission, that enabled for a successful submission.”
- PUBLICATIONS -
“My company has utilized the services of Acumen for writing clinical, regulatory, and manuscript documents since 2018. The Acumen team is great to work with, as they exhibit diligence and attention to detail while adhering to and driving timelines with great follow-up on deliverables. I am extremely satisfied with the services provided by Acumen and will continue to use them in the future.”
John Soglia, PhD
Vice President, Translational Development
Celeste DiJohnson
Vice President, Clinical Operations
- CLINICAL SCIENCE -
“Acumen has consistently provided high-quality work and seamlessly integrated with our internal teams to quickly understand and meet our needs. Across the board, Acumen provides experts with the highest level of ethics and experience. For support of these critical clinical development functions, I highly recommend Acumen.”
- NARRATIVES -
“I have been impressed with the quality of the safety narratives that Acumen has delivered, as well as Acumen’s proactive communication and efficient project management, often per aggressive timelines. Acumen has demonstrated excellent writing, QC, and clinical expertise, and has taken the time to ensure that all of the relevant stakeholders are happy with the end product.”
Patricia Harris
Vice President, Clinical Sciences
Denise Chun, PhD
Head of Global Medical Writing
