Clinical and Regulatory Medical Writing
End-to-End Medical Writing Services for Clinical Trials and Regulatory Submissions
Shen Clinical Services turns complex trial data into clear, compliant documents for regulators, ethics committees, investigators and patients. Our physician-led medical writing team covers the whole development lifecycle, from investigator brochures and protocols to clinical study reports and CTD modules, written to ICH guidelines and India’s New Drugs and Clinical Trials Rules, 2019.
ICH E3, E6(R3), M4Global document standards
NDCT Rules, 2019CDSCO and ethics committee needs
Physician-Led ReviewClinical sense-check on every document
Patient-FriendlyPlain-language consent and summaries
On this page
Document Types
Clinical and Regulatory Writing Across the Development Lifecycle
One team writes every document your programme needs, so the science and the messages stay consistent from the first protocol to the final submission.
| Stage | Documents we write | Written to |
|---|---|---|
| Early development | Investigator’s brochure, nonclinical summaries, clinical trial application documents, briefing documents | ICH E6(R3), ICH M4; NDCT Rules, 2019 |
| Trial start-up | Protocol and amendments, protocol synopsis, informed consent forms and patient information, ethics committee and CTRI submissions | ICH E6(R3), SPIRIT; Third Schedule, Table 3 |
| Trial conduct | SAE narratives, development safety update reports, interim reports | ICH E2F; Third Schedule, Table 5 |
| Results | Clinical study reports, synopses, patient narratives, lay summaries | ICH E3; EU Regulation 536/2014 |
| Submission | CTD Module 2 clinical overview and summaries, Module 5 reports, responses to regulator queries | ICH M4E |
| Post-approval and publication | PSURs and PBRERs, manuscripts, abstracts, posters, systematic reviews | ICH E2C(R2), GPP 2022, CONSORT |
India Expertise
Medical Writing for Clinical Trials in India
Indian trials need documents that satisfy CDSCO, ethics committees and CTRI as well as global sponsors. These are the rules our writers work to:
| Requirement | Rule / timeline |
|---|---|
| Clinical trial application to CDSCO | Form CT-04 (Rule 21, NDCT Rules, 2019) |
| Permission to conduct the trial | Form CT-06; decision within 90 working days (Rule 22) |
| Drugs discovered or developed in India | Deemed approved if CDSCO raises no query within 30 days (Rule 23) |
| Informed consent form | Content set by the Third Schedule, Table 3, in a language the participant understands |
| Serious adverse event reports | Format set by the Third Schedule, Table 5 |
| Trial registration | Registered on the Clinical Trials Registry of India (CTRI) before the first participant is enrolled |
Results Writing
Clinical Trial Results Writing: CSRs, Narratives and Lay Summaries
When the database locks, our regulatory writing specialists turn the tables, listings and figures into the reports regulators, investigators and participants read.
Clinical Study Reports (ICH E3)
Full and abbreviated clinical study reports written to the ICH E3 structure, from synopsis to appendices, with every number checked against the final outputs.
Patient Narratives
Narratives for deaths, serious adverse events and discontinuations, written consistently from source data so reviewers find the same facts in the same place.
Lay Summaries
Plain-language summaries of trial results for participants and the public, as required in the European Union under Regulation 536/2014.
Our Process
How Our Clinical Writing Process Works
STEP 01
Kick-off and Document Plan
We agree scope, templates, style guide, review rounds and dates with your team before writing starts.
STEP 02
Drafting by a Specialist
A writer with experience in your therapeutic area drafts the document from the protocol, data and source reports.
STEP 03
Scientific and Quality Review
A second reviewer checks every number against the source, and a physician reviews the clinical interpretation.
STEP 04
Sign-Off and Submission-Ready Files
We resolve your comments, finalise formatting and hand over documents ready for CDSCO, ethics committees or global regulators.
Why Shen
Why Biopharma Sponsors Choose Our Clinical Medical Writing Experts
- Physician-led: clinicians review the interpretation, not just the grammar
- Writers with M.D., Ph.D. and Pharm.D. backgrounds and therapeutic depth in oncology, cardiovascular, dermatology and biosimilars
- India and global standards in one team, so Indian sites and global submissions use the same core documents
- Flexible engagement: a single document, a full study, or an embedded FSP team
- A dedicated programme manager as your single point of contact
What We Write
Our Clinical Writing Services
Clinical trial protocols and amendments
Informed consent forms
Investigator’s brochures
Clinical study reports (CSR)
Patient narratives
Lay summaries
Safety reports (DSUR, PSUR)
CTD clinical modules
Regulatory query responses
Ethics committee submissions
Manuscripts and abstracts
Systematic reviews
FAQs
Medical Writing Services: Frequently Asked Questions
What do medical writing services include?
Medical writing services cover the documents a drug, biologic or device programme needs from first-in-human to post-approval: investigator brochures, protocols, informed consent forms, clinical study reports, patient narratives, safety reports, CTD modules, regulatory responses and publications. Shen writes each one to the relevant ICH guideline and local rules.
What is the difference between clinical and regulatory medical writing?
Clinical writing produces the documents that run a trial, such as the protocol, informed consent form and investigator brochure. Regulatory writing produces the documents regulators review, such as clinical study reports, CTD summaries and responses to queries. Many documents sit in both, so one team handling both keeps the story consistent from protocol to submission.
Do you write documents for clinical trials in India?
Yes. We prepare the documents for a CDSCO clinical trial application in Form CT-04 under the New Drugs and Clinical Trials Rules, 2019, informed consent forms that follow the Third Schedule, ethics committee submissions and CTRI registration text, alongside global documents written to ICH standards.
How do you keep a clinical study report accurate?
Every number in a clinical study report is checked against the final tables, listings and figures by a second reviewer, and the report follows the ICH E3 structure. A physician reviews the clinical interpretation before the report goes to your team for sign-off.
Can you write patient-friendly lay summaries?
Yes. We write plain-language summaries of trial results and patient information that avoid jargon and explain risks clearly. Lay summaries are mandatory in the European Union under Regulation (EU) No 536/2014, and many sponsors now publish them for every trial.
What engagement models do you offer?
You can hire us for a single document, a full study, or as a functional service provider (FSP) team embedded in your programme. Each engagement has a dedicated programme manager as your single point of contact.
Resource Spotlight
Planning a new study? Our study design and protocol development team shapes the protocol before writing starts. We also run clinical trials in India, handle pharmacovigilance and drug safety, and provide regulatory guidance for CDSCO submissions.
Clear, Compliant Documents, Delivered on Time
One document or a whole programme? Tell us what you need and your deadline, and we will send a scope and quote.
Need writers in your team? Ask about our FSP model.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: ICH E3, Structure and Content of Clinical Study Reports; ICH efficacy guidelines, including E6(R3); ICH M4 Common Technical Document; New Drugs and Clinical Trials Rules, 2019 (CDSCO). General regulatory information, not legal advice.