Question 1

What documents does IDDCR produce as part of medical writing services?

Accepted Answer

IDDCR medical writers produce the full spectrum of regulatory and clinical documents: Clinical Study Reports (CSRs) to ICH E3 format, study protocols and amendments, Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overview and Clinical Summary sections for CTD Module 2, IND/CTA/NDA/MAA submission documents, DSURs, PSURs, and scientific publications. We also produce patient-facing materials and lay summaries.

Question 2

How long does it take to write a Clinical Study Report (CSR)?

Accepted Answer

CSR timelines depend on study complexity, the volume of TLFs, and the number of review cycles. For a straightforward Phase II study, IDDCR typically delivers a first draft within 8–12 weeks of receiving a clean, locked database and final TLFs. Complex Phase III pivotal studies with multiple endpoints and large patient populations may require 16–20 weeks. We provide detailed project timelines at study initiation and track milestones against agreed delivery dates.

Question 3

Does IDDCR write documents to ICH CTD format?

Accepted Answer

Yes. All IDDCR regulatory documents are structured to the ICH Common Technical Document (CTD) format, which is accepted by the FDA, EMA, PMDA, Health Canada, and most other major regulatory agencies. Our medical writers are trained in CTD Module 2 (Clinical Overview, Clinical Summary) and Module 5 (Clinical Study Reports) requirements, and work closely with regulatory affairs specialists to ensure documents meet agency-specific guidance.

Question 4

Can IDDCR support scientific publications and congress abstracts?

Accepted Answer

Yes. IDDCR provides publication planning and writing support for peer-reviewed journal manuscripts, congress abstracts, and poster presentations. We follow ICMJE authorship guidelines and Good Publication Practice (GPP3) standards. Our medical writers work with the study team to develop the publication strategy, draft manuscripts, manage author review cycles, and prepare journal submissions.

Question 5

How does IDDCR ensure quality and consistency across large document sets?

Accepted Answer

IDDCR uses a structured quality management process for medical writing: a lead writer develops a document template and style guide at project initiation; all writers follow the same conventions; a senior medical writer or QC specialist reviews every document before client delivery; and a final editorial check ensures cross-document consistency. We use tracked-changes workflows and version-controlled document management to maintain a clear audit trail.

Medical Writing

Our Approach to Medical Writing

Core Capabilities

Clinical Study Reports

Regulatory Submissions

Study Protocols & Amendments

Informed Consent Forms

Scientific Publications

Investigator Brochures

Therapeutic Areas

Development Phases

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Clinical Trial Management

Clinical Data Management

Biostatistics

Statistical Programming

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