Medical Writing
At WEP, our Medical Writing group provides sponsors with high-quality, regulatory-compliant, and scientifically accurate clinical trial documentation. Our expert medical writers ensure that all documents are clear, concise, and aligned with global regulatory requirements, supporting smooth clinical trial execution and regulatory approvals.
Key Medical Writing Services at WEP include the following:
Develop and Review Essential Clinical Trial Documents
- Clinical Study Protocols (CSPs): Ensure scientific clarity and regulatory alignment.
- Investigator’s Brochures (IBs): Provide comprehensive safety and efficacy data for investigators.
- Informed Consent Forms (ICFs): Ensure ethical compliance and patient comprehension.
- Clinical Study Reports (CSRs): Summarize trial results for regulatory submission.
- Common Technical Document (CTD/eCTD) Modules: Support NDA/BLA/MAA submissions.
- Risk Management Plans (RMPs): Outline risk mitigation strategies for regulatory bodies.
Regulatory Submissions & Compliance Support
- Draft and submits regulatory documents for INDs, CTAs, NDAs, BLAs, and MAAs.
- Ensure compliance with ICH-GCP, FDA, EMA, MHRA, and other regulatory agency guidelines.
- Provide support for regulatory meetings, queries, and responses.
Safety & Pharmacovigilance Writing
- Develop Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
- Prepare adverse event (AE) and serious adverse event (SAE) summaries.
- Support pharmacovigilance teams with signal detection and risk-benefit assessments.
Scientific & Medical Communications
- Create peer-reviewed publications, conference abstracts, and posters.
- Develop white papers, literature reviews, and medical education materials.
- Assist Sponsors in crafting layperson summaries for patient engagement.
Quality Control & Editorial Review
- Ensure documents are scientifically accurate, well-structured, and regulatory-compliant.
- Provide technical editing, consistency checks, and data verification.
- Conduct thorough quality control (QC) reviews before final submissions.
Why Choose WEP’s Medical Writing Team?
- Experienced Medical Writers: Experts with scientific, regulatory, and clinical backgrounds.
- Regulatory & Scientific Expertise: Deep understanding of global regulatory requirements (FDA, EMA, MHRA, PMDA, Health Canada).
- Clear & Concise Writing: Ensure accuracy, clarity, and compliance across all trial documents.
- Seamless CRO Integration: Work closely with WEP’s Regulatory Affairs, Medical Affairs, and Clinical Operations teams.
- Accelerated Submission Timelines: Efficient documentation processes that reduce delays and enhance approval speed.