Phase 2 · Weeks 13–26

Applied Portfolio

Write real documents from real source material. Four deliverables, each reviewed by a senior writer with iteration cycles modelled on industry practice.

Four deliverables

The documents on your portfolio.

01Weeks 13–17

Clinical Study Report section

Draft a complete ICH E3-compliant CSR section from a real protocol and statistical outputs. Integrate TLF data into a regulatory narrative, apply correct conventions, and iterate against marked-up feedback.

Skills

ICH E3 structure and section logic
Integrating TLF outputs into narrative
Efficacy or safety section drafting
Tracked-changes revision cycle

Resources

The brief

Using a real published protocol from ClinicalTrials.gov and the associated published results, draft Section 11.4 (overall efficacy results) or Section 12.1 (adverse events overview) to ICH E3 standard. Target 800–1200 words. Submit for senior writer review.

02Weeks 18–20

MHRA regulator query response

Assess a realistic MHRA query about a protocol design issue, construct a justified scientific response citing relevant guidelines, and defend it against a follow-up challenge.

Skills

Regulatory query interpretation
Scientific justification writing
Formal response format and tone
Agency dialogue simulation

Resources

The brief

You will be given a realistic MHRA query about a protocol design issue. Write a 400–600 word formal response: acknowledge the query, provide scientific justification, cite relevant guidelines, and conclude with your position. Then defend it against a follow-up challenge from your reviewer.

03Weeks 21–23

CTD module section

Draft a Module 2.5 Clinical Overview extract covering the benefit-risk assessment. This is critical appraisal, not data summary.

Skills

ICH M4E Clinical Overview requirements
Benefit-risk assessment writing
CTD formatting and cross-referencing
Self-QC against regulatory checklist

Resources

The brief

Using the same trial data as Deliverable 1, draft a 600–900 word extract from the Clinical Overview (Module 2.5) covering the overall benefit-risk assessment. This is a critical appraisal — not a data summary. Submit for senior writer review with tracked changes.

04Weeks 24–26

Advanced deliverable

Scoped to your career direction. Choose from an Investigator's Brochure update section, an RMP safety concern entry, or a health authority briefing document.

Skills

IB update, RMP section, or briefing document
Guideline-specific drafting (E2F or GVP Module V)
Two-cycle senior writer review
Interview-ready articulation of your decisions

Resources

The brief

Choose your advanced deliverable based on your target role. Draft to the applicable guideline standard. Full senior writer review with two iteration cycles.

The review cycle