Medical Writing

Core Clinical & Regulatory Documents

• Protocols & Amendments: Objectives, endpoints, estimands, design, statistical framework, and operational details aligned to ICH E6/E8.
• Investigator’s Brochure (IB): Benefit–risk summaries, nonclinical/clinical updates, safety profile, and version control.
• Clinical Study Reports (CSRs): ICH E3-compliant with integrated TLFs, deviations, analysis populations, and sensitivity outcomes.
• Informed Consent Forms (ICFs): Clear patient-centric language and localization support.
• Lay Summaries: Plain-language summaries for trial participants and public disclosure portals.

Analysis-Aligned Deliverables

• SAP & Shells: Partnering with biostatistics on SAPs, shells, and derivations to ensure narrative consistency with results.
• Clinical Summaries (CTD 2.5/2.7): Integrated summaries of efficacy (ISE) and safety (ISS) aligned to Module 5 outputs.
• Narratives: Automated templates for AEs/SAEs/deaths/dropouts; targeted medical review for complex cases.
• Responses to Authorities: Clear, evidence-based replies with tracked changes and document histories.

Governance, QC, and Disclosure

• Style Guides & Templates: Sponsor-branded templates with section-level guidance and boilerplates.
• Quality Control: Editorial, scientific, and compliance QC; cross-checks against SAP, TLFs, and source data.
• Document Management: Version control, references, TMF filing, and redaction for public disclosure.
• Timeline Management: Content plans, review cycles, comment reconciliations, and sign-off matrices.

Therapeutic Experience

Oncology, immunology, neuromuscular and rare diseases, infectious disease, cardiometabolic, and more — with document strategies tailored to indication-specific endpoints and regulatory expectations.