Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
Medical Writing
We provide expert medical writing assistance for protocols, CSRs, regulatory documents, and publications—for clear, compliant, scientifically accurate documentation.
Comprehensive Medical Writing Support
We support your organization across medical writing deliverables—from protocol development through CSR completion and publication preparation. Our experienced medical writers integrate with your team to deliver high-quality documentation prepared to regulatory requirements.
As your medical writing support partner, we bring scientific expertise, regulatory knowledge, and meticulous attention to detail, supporting clear and compliant clinical documents.
Our approach
How We Support Your Medical Writing
- 01
Document Planning
We review requirements, develop outlines, and establish timelines for your writing deliverables aligned with project needs.
- 02
Drafting & Development
We prepare initial drafts following regulatory standards, therapeutic area norms, and your organization’s templates and style guides.
- 03
Review & Revision
We incorporate feedback from reviewers, address queries and comments, and refine documents through iterative review cycles.
- 04
Finalization & QC
We perform final quality checks, format documents per specifications, and deliver publication-ready materials with full documentation.
Deliverables
What You Receive
Clinical Protocols
Scientifically sound protocols written to ICH and therapeutic-area guidelines.
ICFs
Clear, patient-friendly informed consent documents prepared to ethical and regulatory requirements.
CSRs
Comprehensive clinical study reports per ICH E3 guidelines ready for regulatory submission.
Investigator’s Brochures
Well-structured IB updates with current safety and efficacy information.
Regulatory Documents
Query responses, briefing documents, and regulatory correspondence properly formatted.
Publications
Journal-ready manuscripts, abstracts, and posters prepared to each journal’s requirements.
Why Prequel
The Prequel Advantage
Regulatory Expertise
Working knowledge of ICH guidelines and of CDSCO (NDCT Rules, 2019), US FDA and EMA requirements for clinical and regulatory documents.
Efficient Document Cycles
Templates, style guides and parallel review keep document cycles efficient without trading away quality.
Therapeutic Knowledge
Writers with scientific backgrounds, and experience in oncology, rare disease, devices and post-marketing safety.
Quality Review
Independent editorial QC built into our deliverables, supporting accuracy and consistency.
When you need us
Common Scenarios
CSR Deadline
Database locked and you need experienced medical writers to complete the CSR against regulatory timelines.
Protocol Development
New study requires protocol drafting expertise with regulatory knowledge and therapeutic area understanding.
Resource Constraints
Medical writing team at capacity with multiple simultaneous deliverables across different trials and documents.
Publication Support
Trial results ready for publication but lack medical writing resources or journal submission expertise.
Related support services
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Ready to Enhance Your Documentation Quality?
Let’s discuss how our medical writing support can strengthen your documentation, from protocol through to CSR and publication.