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December 2, 2020

Together for
Documenting Results

Medical Writing

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

  • 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

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).

Medical Writing Services Brochure

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Testimonials

  • Medical Director
    APCER’s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
    Medical Director
    US-based specialty pharmaceutical company
  • QPPV and Pharmacovigilance Head
    The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
    QPPV and Pharmacovigilance Head
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company
  • Head, Clinical Trial Transparency
    APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
    Head, Clinical Trial Transparency
    Top 10 pharmaceutical company with operations in the EU and US
  • AVP, Pharmacovigilance
    We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
    AVP, Pharmacovigilance
    US-based pharmaceutical company
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company

How can we work together for better health?

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    APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory and technology resources to ensure that patients receive the safest, most effective therapies possible.

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