Description
Clinical Study Synopsis | ICH-Compliant Summaries for Regulatory Submissions
A clinical study synopsis condenses a study into the brief, structured summary that regulators, ethics committees and registries read first: its design, population, endpoints, statistical methods and, for a completed study, its results. Our medical writers prepare protocol synopses and clinical study report (CSR) synopses that follow the ICH structure and stay consistent with your source documents.
Service Details
| Service type | Regulatory medical writing |
| Best for | Protocol synopses at study start-up; CSR synopses at study close; study summaries for regulatory submissions |
| Standard | ICH structure (ICH E3 synopsis for completed studies) |
| Timeline | Agreed with you at scoping, based on study size and data readiness |
What a CSR Synopsis Covers
- Study title, investigators, study centres and study period
- Phase of development and study objectives
- Methodology and number of patients planned and analysed
- Diagnosis and main inclusion criteria
- Test product, dose, mode of administration and duration of treatment
- Reference therapy
- Criteria for evaluation of efficacy and safety
- Statistical methods
- Summary of results and conclusions
How It Works
- Send us the protocol or clinical study report, plus the statistical outputs for a results synopsis
- We draft the synopsis against the ICH structure
- You review the draft and we revise based on your feedback
- You receive the final synopsis, ready for your submission package
Which Service Do You Need?
Need the full report rather than its summary? See Clinical Study Report (CSR) – ICH E3 Compliant. Writing the protocol itself? See Clinical Protocol Development. Need a patient-friendly version of your results? See Plain Language Summary (EU CTR/Journal).
Frequently Asked Questions
What is the difference between a protocol synopsis and a CSR synopsis?
A protocol synopsis summarises the planned study before it starts. A CSR synopsis summarises the completed study, including its results and conclusions.
What do you need from me?
The protocol or clinical study report, and for a results synopsis the final statistical outputs.
Is the synopsis suitable for regulatory submissions?
Yes. It follows the ICH structure used in regulatory submissions.
Get started: add this service to your cart, or email co*****@*******se.com with your protocol or clinical study report to agree scope and timeline.
