Medical Writing New

Together for Documenting Results

Medical Writing

Medical Writing demands specialized skills. Compliance with stringent regulatory guidelines, addressing diverse audience needs, maintaining data integrity, and communicating complex research data accurately and timely require skilled medical writers.

APCER Life Sciences’ Medical Writing team helps you bring your research to physicians and healthcare providers (HCPs), patients, caregivers, regulators, and other stakeholders by effectively communicating scientific data in the right context through well-crafted documents across a product lifecycle.

Medical Writing Services

Protocols
Informed Consent Documents
Investigator’s Brochures
Patient Safety Narratives
Clinical Study Reports
Clinical Trial Disclosures

Protocol Registration Forms
Basic Results
Web Synopses
Layperson’s Summaries

Investigational New Drugs/New Drug Applications/Biologic Licensing Applications
Common Technical Document Modules (2.4, 2.5, 2.6, 2.7, 4, 5)
Briefing Documents for meetings with regulatory authorities
Paediatric Investigational Plans
Drug Designations
(Orphan Drug Designation, Accelerated Review Application, Priority Review Application, etc.)
Annual Reports
Company Core Data Sheets
Drug monographs
Labels : SmPCs/PIs; PILs/Medication Guides

Manuscripts/Review articles
Conference Support: Abstracts, Posters, and Slide Decks
Infographics, HTML e-mailers
Newsletters
Leave-Behind Leaflets
Continuing Medical Education Slide Decks
Web Content
Standard/Customized Response Letters

Clinical Evaluation Plans
Clinical Evaluation Reports
Post-Market Clinical Follow-Up Plans
Post-Market Clinical Follow-Up Reports
Summaries of Safety and Clinical Performance
Periodic Safety Update Report
Post-Market Surveillance Plans
Post-Market Surveillance Reports

Quality Control review of clinical, regulatory, and scientific documents

Support for Additional Risk Minimization Measures (aRMMs)

Preparing protocols, informed consent documents, and clinical study reports for:
- Registry/Observational Studies
- Real-World Evidence (RWE) Studies
- Post-Authorization Safety Studies (PASSs) and Post-Authorization Efficacy Studies (PAESs)
- Observational Pharmacoepidemiologic Studies
- Clinical trials with safety endpoint [Section 505(o)(3)]

Annual Update/Annual Reports

Updating clinical and nonclinical sections, as applicable
Preparing annual reports for registry/observational studies

Variation Filing

EU: Safety variation filings
SmPC/PIL Safety Update/Annual Review; Clinical Expert Statement (CES) preparation; Addendum to Clinical Overview (ADCO)

Reimbursement Dossiers
Review of advertising and promotional materials
Educational materials (brochures, handouts, e-learning modules, content for CMEs, physicians, patients, and salesforces)

Why Choose APCER’s Medical Writing Services?

Explore Our Medical Writing Case Studies

Learn how we updated a complex Investigator Brochure within demanding timelines.

Discover how our Medical Writers enabled CTD Modules preparation within stringent timelines.

Explore how we compiled real world data and created a complex observational study report.

Find out how we helped a medical device company establish a robust process for delivering high-volume reports.

How can we work together for better health?

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