Document gap analysis
$750
I review a draft protocol or CSR against ICH standards and give you a marked-up list of what will generate review comments, and why. Includes a call to walk through the findings.
Vaccines & infectious disease
LOVELYN CHARLES
Regulatory documents that survive review.
Protocols, Investigator's Brochures, Clinical Study Reports and briefing packages — written by the clinical science lead who ran the studies behind them.
10+ years vaccine development
Phase 1–3 and post-approval
ICH E3 · E6(R3) FDA · Health Canada · EMA
What I write
Nine document types, start to QC-ready.
- 01Clinical study reportsICH E3, draft through to QC-ready
- 02Clinical study protocols and amendmentsfull protocol and synopsis, ICH E6(R3)
- 03Investigator's Brochuresnew documents and annual updates
- 04Regulatory briefing packagespre-IND and Type B/Type C meeting packages, with Q&A strategy
- 05Development Safety Update ReportsDSURs and aggregate safety narratives
- 06Informed consent forms and patient-facing documentsincluding plain-language summaries
- 07ClinicalTrials.gov registrations and results postingsstatutory disclosure under FDAAA 801
- 08Clinical sections of grant and funding submissionsCEPI, BARDA, Gates, Wellcome
- 09Document gap analysis and QC reviewdraft documents assessed against ICH standards
Most regulatory writers have written these documents.
Fewer have had to execute against them.
I was clinical science lead on the post-approval programme for a licensed monoclonal antibody for Ebola, where I owned the FDA post-marketing requirements. I led clinical science on a Phase 1 vaccine study for a disease with no approved vaccine, and authored the CSR and the adaptive trial design synopses for Phase 2 and Phase 3. Earlier in my career I managed investigational product on Phase 2 trials in West Africa for GSK and Johnson & Johnson.
That means I know why these documents are written the way they are, because I have also been the person who had to run a study against them. In practice it shows up as fewer review cycles: fewer questions about what a deviation actually meant, fewer conclusions that outrun the design, fewer synopses that contradict the body.
Selected evidence
- Clinical science lead, post-approval programme for a licensed monoclonal antibody for Ebola. Owned the FDA post-marketing requirements and commitments, from study design through delivery.
- Clinical science lead, Phase 1 Lassa fever vaccine trial. Executed the full Phase 1 study, and authored the CSR and the adaptive trial design synopses underpinning Phase 2 and Phase 3 planning.
- Co-author of two books. Clinical Trials: Design, Execution and Analysis and Post-Marketing Surveillance: Identifying Outcomes in the Community, Apteryx Media, 2026.
- Published on Lassa vaccine safety. A Brighton Collaboration BRAVATO benefit/risk template for a VSV-vectored Lassa fever vaccine (Vaccine, 2025), and a CEPI SPEAC report on sensorineural hearing loss in Lassa virus disease.
- Unblinded pharmacist on two Phase 2 vaccine trials. The first Ebola vaccine trial conducted in Nigeria, for GSK, and a prime-boost regimen for Johnson & Johnson whose product is now authorised in the EU.
- Site and study manager, UBC Vaccine Evaluation Center, Vancouver. Managed a Phase 3 meningococcal vaccine trial, coordinated the MOSAIC Canada study during the COVID-19 pandemic, and was unblinded pharmacist on an infant Phase 2/3 study.
- ClinicalTrials.gov PRS Administrator, Emergent BioSolutions. Trial registration and results disclosure across the portfolio.
- Enrolment target exceeded. 531 participants against a target of 500, ahead of schedule, with no delays attributable to investigational product supply or cold chain.
- Funding submissions. Authored an executive summary report to support governance review, stage-gate assessment and strategic decision-making for a clinical development programme.
How engagements work
Fixed fee per document. You approve a scope and a number, not an hourly estimate that drifts. Full documents are quoted on scope — a Clinical Study Report or Investigator's Brochure is a multi-week engagement. Day rate available where a programme needs ongoing support rather than a deliverable.
Start anywhere. From a blank page, from a messy internal draft, or from a document that has already been through three rounds of review and needs someone to break the loop.
Inside your systems. Comfortable working in sponsor and CRO templates, style guides and document management systems rather than imposing my own.
Remote, Pacific Time. Overlapping hours with both European and North American teams.
Available from August 2026.
Start smaller
Three ways to start small. Each one is real work you can judge me on.
Half-day regulatory review call
$900
You bring the problem, I bring the opinion. No deliverable to negotiate.
Protocol synopsis
$1,500
Built from your existing draft protocol or concept documents. A complete, bounded piece of writing you can circulate. Two rounds of consolidated review comments included.
Credentials
- MSc Pharmaceutical Sciences, University of British Columbia
- MSc Pharmaceutics & Drug Delivery and B.Pharm, University of Nigeria
- ACRP-CP · PEBC International Pharmacy Credential Assessment
- ICH-GCP · Health Canada Division 5 · TCPS 2
- Writing in the Sciences, Stanford University
- Policy Development and Advocacy for Global Health, University of Washington
- Member, American Medical Writers Association
- ORCID 0000-0003-2107-3295
How I work
Regulatory documents are slow for structural reasons, and some of that is unavoidable. Some of it isn't.
I use AI tooling inside a controlled workflow to compress the parts that are genuinely mechanical: first-pass structuring, consistency checking across a long document, and finding the mismatches between a synopsis and a body before a reviewer does. Judgment, interpretation and every regulatory conclusion stay human, because that is what a sponsor is actually paying for and what a reviewer will hold someone accountable for.
The practical effect is that documents come back faster without coming back thinner.