The 7 Biomedical Writing Domains
Biopharmaceutical companies, global CROs, and MedComms agencies structure documentation across seven core functional domains. IMRAD Academy covers each domain with audit-ready rigor aligned to international authorities. Start with the six foundation courses (ICH-GCP in Practice applies to the regulatory, safety, medical information, market access and device pathways), then add the domain-specific professional courses for your target role.
All courses are included in one subscription — choose your primary domain or cross-train across regulatory, safety, publications, and commercial medical documentation.
Domain 1
Publications & Manuscripts
Original manuscripts, PRISMA 2020 systematic reviews, congress abstracts, posters, and rebuttal letters.
- Foundations (6 courses)
- Writing the Manuscript
- Congress Materials
- Med Comms & Publication Standards
- Systematic Reviews
Domain 2
Regulatory Medical Writing
ICH E3 CSRs, 1,500-word patient narratives, Investigator's Brochures (IB), protocols, eCTD Module 2 summaries, and CRL responses.
- Foundations (6 courses)
- Regulatory Medical Writing
Domain 3
PV & Safety Writing
ICSR narratives, MedDRA coding, PBRER/PSUR (ICH E2C R2), DSUR (ICH E2F), EU RMP / US REMS, and signal detection reports.
- Foundations (6 courses)
- PV & Safety Writing
Domain 4
Medical Information (MedInfo)
Standard Response Documents (SRDs), reactive HCP inquiries, off-label safe harbors, and AE/complaint intake triage.
- Foundations (6 courses)
- Medical Information Writing
Prepares for: MWC
Domain 5
Medical Affairs & Field Medical
MSL scientific exchange decks, advisory board briefing packs, scientific platforms, insight capture, and KOL engagement.
- Foundations (6 courses)
- Field Medical Materials
- Congress Materials
- Med Comms & Publication Standards
Domain 6
HEOR & Market Access
Global Value Dossiers (GVDs), AMCP formulary submissions, HTA dossiers (NICE/PBAC), and cost-effectiveness (QALY/ICER) write-ups.
- Foundations (6 courses)
- Systematic Reviews
- HEOR & Market Access Writing
- Med Comms & Publication Standards
Domain 7
Medical Device Writing (EU MDR)
Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER per MEDDEV 2.7/1 Rev 4 & EU MDR 2017/745), PMCF, and SSCP summaries.
- Foundations (6 courses)
- Systematic Reviews
- Regulatory Medical Writing
- Medical Device Writing
Prepares for: RAC-Devices, MWC
Not sure where to begin? The survey course below is free and outlines the entire biopharma writing landscape —
the shortest route to identify your target domain. Every modular course opens with a 24-question diagnostic to identify your exact gaps.
Start here
The survey course
The whole of medical writing in outline, from what the industry is to how a document gets
made. Free. Everything below goes deeper into one part of it.“What is this field, and where do I fit?”
Shared across all pathways
Foundations
The skills every document assumes: clear scientific English, statistics, source-document navigation, critical appraisal, the regulatory landscape, and ICH-GCP. Complete these before specialising.“Can I read the evidence and navigate the environment?”
Domain-specific courses
Professional
One course per deliverable or domain, taught to the standard a reviewer or client actually applies. Each maps to global certification exam domains. Take the ones that match your target pathway.“Can I produce the document and earn the IMRAD certificate?”
How progress tracking works
Your progress is stored in this browser only and is never sent anywhere. It appears here automatically once you start a course, provided all the course files are served from the same website. Clearing your browser data will reset it, and progress does not follow you to another device.