Scientific Communication

– Manuscripts
– Abstracts
– Conference slide kits
– Posters
– Review articles
– Drug monographs

Medical Writing

– CME slide kits
– Standard response letters and FAQs
– Customized response letters
– Reimbursement dossiers
– Medication guides and questionnaires
– Patient information leaflets

Clinical Writing

– Investigator brochures
– Clinical study protocols
– Informed consent documents
– Clinical study reports
– Patient safety narratives

Regulatory Writing

– Common Technical Documents
– Clinical and non-clinical overviews
– Summary of product characteristics
– Clinical expert statements
– Briefing documents
– IND/NDAs
– Labelling and core data sheets

Benefit/Risk Reports

– Annual updates
– Aggregate reports
– Risk management plans
– REMS
– Safety update reports

Web Synopses

– Clinicaltrials.gov
– EU clinical trials register
– Company-specific websites

We work together

“
I am completely satisfied with APCER, and that is why they keep getting more and more work. A previous vendor was not meeting the quality we required, so APCER took on a project in regulatory affairs at the last minute. Since then, they have continued to prove their value with respect to quality, efficiency, and cost. They are cost-competitive and very, very dependable. I am impressed by them.

- Regional Head, Global Medical Writing, Top 10 global pharmaceutical and consumer healthcare company

We selected APCER because they were an all-encompassing services provider in that they were able to help us with pharmacovigilance, both in the U.S. and in Europe, as well as Medical Information. They had QPPVs on staff and did not have to subcontract to fill that requirement. The most important attributes we look for are commitments to compliance, quality, and client relations, and we are completely satisfied with APCER in these areas. We have a wonderful relationship with them.

- Director, Pharmacovigilance, Biopharmaceutical company

When we entered the U.S. market with our product portfolio, we wanted one company to handle our US and European sectors. APCER had the global capabilities we were looking for, and they have proven to be efficient and accessible. We are completely satisfied.

- Head, Regulatory Affairs, global generics manufacturer

Together, to Exchange Information

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.

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Together, because events require analysis

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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