All modules — detailed view
What you get
Interactive guidelines directory with canonical references, methodology summaries, and regulatory guidance for any RWE question.
What you get
Comprehensive data source inventory, literature gap analysis, competitor study mapping, and regulatory precedent review — structured as a 5–10 page landscape brief.
What you get
A 3–7 page HARPER-aligned study concept sheet covering objectives, PICOTS framework, study design rationale, preliminary data source selection, and regulatory context.
What you get
A 5–30 page feasibility report with patient count estimates, ICD code coverage analysis, database scoring against study parameters, risk evaluation, and a clear Go/No-Go recommendation — plus a database landscaping spreadsheet.
What you get
A 40–70 page HARPER + EMA GVP VIII-compliant study protocol covering background, objectives, methodology, statistical considerations, ethical provisions, and two HARPER tables justifying every design choice.
What you get
A 30–50 page statistical analysis plan with estimand framework, sample size, analysis populations, exposure/outcome/confounder evaluation, subgroup and sensitivity analyses — plus 10–12 study-tailored TFL shells in Excel.
What you get
A complete statistical code package in R, SAS, Python, or Stata — annotated, production-ready, aligned to your SAP and data model (OMOP, FHIR, claims). Delivered as a ZIP archive with macro libraries and execution scripts.
What you get
Data preparation, cleaning, and structuring for RWE analysis across OMOP, FHIR, claims, EHR, and registry sources.
What you get
Run primary and sensitivity analyses with output-ready tables, figures, and listings aligned to your SAP.
What you get
A 100–200 page clinical study report structured per ICH E3, RECORD, or GVP Module VIII, integrating protocol, results tables, and narrative sections.
What you get
A polished first draft manuscript structured for your target journal and reporting guideline (STROBE, RECORD-PE, CONSORT, PRISMA), with inline citations and discussion section.
What you get
A structured regulatory and HTA dossier acceptability report — probability of success, stakeholder context, major and minor comments, and a prioritised action plan — from the perspective of your selected body.
What you get
A structured critical appraisal of any manuscript, protocol, SAP, or report — identifying methodological strengths, limitations, reporting gaps, and quality scores against CASP, STROBE, CONSORT, PRISMA, or GRADE frameworks.