APCER's team of medical writers helps life sciences companies craft medical, clinical, and regulatory documents and stay in compliance throughout the product lifecycle.
Developing and marketing medical products requires a constant output of high quality scientific writing. APCER Life Sciences has an experienced team of writers with clinical, medical, and regulatory expertise to help companies document efficacy and safety and stay in compliance worldwide throughout the product lifecycle. With strengths in project governance and information technology, APCER develops and executes integrated processes that facilitate the transfer of data and knowledge. All content is either written by or written under the close supervision of a physician, always.
Scientific Communication
Medical Writing
Clinical Writing
Regulatory Writing
Benefit/Risk Reports
Web Synopses
APCER has extensive experience in signal detection and benefit-risk analysis. Our teams perform regular signal analyses and can create the complete report or sections of the Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Summary Bridging Reports (SBRs), PSUR Addendum Reports (ARs), and Development Safety Update Reports (DSURs).
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