Medical Writing for Clinical Trials
Get Your Story Submission-Ready
Our medical writing for clinical trials consistently reduces rework and strengthens regulatory alignment across clinical development phases, so you can move at the speed of science.
Your New Medical Writing Team
For most CROs, medical writing groups are order takers and document producers with no stake in your success. We do things differently.
With an average of 20 years of experience, our medical writers become part of your team, adapting to your templates with ownership-driven, proactive guidance. We integrate cross-functionally to:
Standardize Document Consistency at Scale
With a single lead author per deliverable, scalable contributor support to meet timelines, and integrated QC, we reduce variability and strengthen alignment across all outputs.
Strengthen Quality With Independent Review
Our embedded quality process includes peer review, draft QC for accuracy, and final QC prior to approval to promote consistency, compliance, and precision.
Accelerate Delivery with Defined Timelines
Our structured workflows and clear targets create predictability, enabling faster cycles without compromising quality or regulatory rigor.
Enhance Efficiency with Smart Automation
We apply automation where it adds value, using regulatory-appropriate tools to improve consistency, reduce manual effort, and accelerate delivery.
Our Services for Medical Writing in Clinical Trials
Our ownership mindset means we’re committed to your success from the moment our partnership begins, bringing our knowledge to consult and guide your approach and support with delivery across:
- Study-related documents:Protocol outline (study design), CSP (gap analysis, full CSP development, protocol modifications), core ICF, IB (initial and updates), CSR and CSR narratives, device documents (CIP, CIR), and e-publishing of regulatory documents where applicable
- Public disclosure and publications:Public disclosure versions (CSP, CSR, SAP), lay language summaries, and peer-reviewed publications
- Submissions and development plans:IND support, eCTD/CTD writing, including M2.5, M2.7, and ISE/ISS
How Does Caidya Optimize Your Clinical Trial’s Medical Writing?
Our experienced medical and regulatory writers combine scientific insight, language skills, writing techniques, table and figure design, and pharmaceutical regulatory knowledge to deliver the highest-quality documents from draft to finished product.
In the last ten years, across the globe we’ve supported:
- 310+ clinical study reports
- 330+ clinical study protocols (CSP) and protocol amendments
- 270+ informed consent forms
- 120+ investigator’s brochures
- 60+ clinical summary documents for eCTD submissions
Frequently Asked Questions About
Medical Writing in Clinical Trials
Which document types does Caidya’s medical writing team support (study, disclosure, submissions)?
Study–related documents: Protocol Outline (Study Design) development, full Clinical Study Protocol (CSP) development or finalization after a protocol gap analysis by senior medical writer, CSP Amendments (Modifications); Core Informed Consent Form (ICF); Investigator’s Brochure (IB); Clinical Study Report (CSR) & CSR Narratives; Devices: CIP, CIR
Public disclosure documents of CSP, CSR, Statistical Analysis Plans (SAPs); Lay language Summaries; Peer-reviewed publications;
Submission and development plans: IND Support; Orphan Drug Designation (ODD); Briefing Book (BB); FIH Development Drug Management Plan (DRMP); eCTD M2.5, M2.7, Integrated Summaries of Efficacy (ISE) and Safety (ISS)
Can Caidya work in our templates and style guide, or use Caidya SOPs?
We deliver truly personalized experiences that mold to your needs, operating with our own Standard Operating Procedures (SOPs) or drafting in line with your templates and style guides.
How do you ensure consistency across protocols, CSRs, narratives, and submission modules?
Ensuring total consistency is essential when drafting your most crucial documentation. We assign one leading author per document while ensuring multiple contributors are on hand to deliver against your timelines.
What quality checks are built into your writing process (review + QC)?
All medical writing deliverables will undergo an independent senior medical writer review to ensure adherence to applicable guidelines and coherence to key messages. The final drafts are QC‘d again before approval. Our approach helps us achieve the highest quality across every piece.
What are typical timelines for protocol and CSR drafting and revision cycles?
We are committed to creating project-specific timelines that both meet client expectations and set realistic parameters for deliverables for each project. Timelines depend on document complexity as well as the number and length of review cycles. On average, the first draft of the clinical study protocol requires 15 to 20 working days, and following a 5-day client review, another 5 to 10 working days for the second draft. The final draft requires up to 6 working days after another 5-day client review.
After the database lock and the final TFLs, the first draft of a full CSR requires 20 to 25 working days —depending on outcome complexity — followed by 10 additional days for the second draft, with 5 days of client reviews between drafts. The final CSR requires up to 7 working days.
Do you support public disclosure deliverables (e.g., disclosure versions, lay summaries)?
Yes, we create public disclosure documents of CSP, CSR, Statistical Analysis Plans (SAPs) and support peer-reviewed publications and lay language summaries.
What automation tools or accelerators do you use for narratives/formatting?
We apply automation where it adds value, using an AI-powered narrative tool for narrative generation and a CSP semi-auto library for CSP generation. It is worth mentioning that CSR automation is in development.