Patient Narratives
Efficient, integrated, and patient-focused narrative development customized to Sponsor needs.
“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.”
THE ACUMEN INTEGRATED NARRATIVE PROCESS DIFFERENCE
We know that narratives are a complex and labor-intensive endeavor requiring a drain on internal resources across multiple functions. Frequently, narratives are outsourced to CROs that are relegated to ex-US writers who do not specialize in narrative writing.
We strongly believe that patients deserve to have their story told with integrity and medical accuracy. Our proprietary Acumen Integrated Narrative Process (INP) encompasses an end-to-end solution that delivers the best-in-class, submission-ready narratives utilizing the Acumen Smart Document Solution. Our US-based team is a cooperative enterprise of dedicated clinical statistical programmers, narrative writers, clinical MDs, and quality control experts with a combined clinical experience of over 40+ years.
Patients commit to clinical trials. We commit to telling their stories.
5000+ Narratives
20+ Sponsors
10+ Successful US and Global Submissions
People Writing about People
We engage. We collaborate. We deliver.
Acumen understands that safety narratives are a strategically important component of regulatory submissions and critical to supporting a product’s safety profile. Clear and accurate narratives are also key to addressing regulatory agency requests for information and may be highly valuable in business development interactions. We distinguish ourselves on the ability to consistently deliver the highest quality narratives based on the following key elements.
Our dedicated team of US-based narrative writers are specialized and trained for each project. We never outsource!
Our medical reviewers are performed by US-trained physicians with direct oversight by our CMO
Our dedicated team of QC and editorial specialists perform 100% QC to data sources following a narrative specific checklist and assure consistent formatting and style across the entire project
End-to-end project management ensures a dedicated point-of contact keeps our process on track and on time. YOUR timelines are OUR timelines
Technology Makes our INP Better
Acumen’s Smart Document Solution, a cloud-based software that seamlessly integrates with Microsoft Word, is designed to address the key challenges of preparing high-quality regulatory documents for the pharmaceutical industry.
Choose from one of our narrative templates, guaranteed to present all the critical narrative elements in an organized and readable format. Our team will work with you to adapt the templates based upon your data to meet your needs and our highest expectations
Our statistical programming step populates your clinical data directly into the narrative template, thereby minimizing transcription errors, ensuring consistent event presentation and flow across all narratives, and making data refreshes quick and easy.