Structured drafts from page one.
A library of templates across clinical, academic, and grant work, built on frameworks like ICH E3, ICH M11, and FDA guidance. Each one lays out the sections for you, with per-section instructions and grounding so the draft stays anchored to your reference library.
Templates
The full library.
Browse by domain, every template grounded in its source framework, ready to open and fill.
Clinical
31 templates
Clinical Study Report (CSR)An ICH E3-aligned template for documenting study conduct, efficacy, safety, and statistical results.Use template →Clinical Study Protocol (CSP)An ICH M11-compliant template for designing and documenting clinical trial objectives, methodology, endpoints, and operational procedures.Use template →Investigator's Brochure (IB)An ICH E6(R3)-aligned template for compiling nonclinical, clinical, and safety information about an investigational product.Use template →IND ApplicationA structured template for assembling clinical, nonclinical, and CMC information required for an Investigational New Drug submission.Use template →NDA Submission SummaryA template for organizing key scientific, clinical, and regulatory information supporting a New Drug Application.Use template →BLA Submission SummaryA template for compiling regulatory information required to support a Biologics License Application.Use template →Orphan Drug Designation RequestA template aligned with FDA requirements for seeking orphan designation for rare disease products.Use template →Fast Track Designation RequestA template for preparing FDA Fast Track designation submissions.Use template →CMC Development PlanA template for documenting manufacturing, analytical, and quality strategies throughout product development.Use template →Serious Adverse Event NarrativeA template for preparing regulatory-compliant narratives describing serious adverse events.Use template →Informed Consent Form (ICF)An ICH E6(R3)-compliant template for preparing participant consent documents for clinical studies.Use template →Statistical Analysis Plan (SAP)A template for defining statistical methodologies and analyses before database lock and study unblinding.Use template →Clinical Development Plan (CDP)A template for defining the overall clinical strategy, development milestones, and evidence-generation plan for a therapeutic program.Use template →Target Product Profile (TPP)A structured template for defining the intended clinical, regulatory, and commercial characteristics of a future product.Use template →Data Monitoring Committee CharterA template for documenting the roles, responsibilities, and operating procedures of an independent monitoring committee.Use template →Clinical Trial Master File (TMF) IndexA template for organizing essential study documents in accordance with GCP requirements.Use template →Investigator-Sponsored Trial AgreementA framework for documenting responsibilities, funding, and operational arrangements for investigator-led studies.Use template →Pre-IND Meeting Briefing PackageAn FDA-focused template for preparing briefing materials and questions for a Pre-IND meeting.Use template →FDA Meeting Request PackageA template for requesting and preparing Type A, B, or C meetings with the FDA.Use template →End-of-Phase 2 Briefing PackageA template for presenting Phase 2 results and obtaining FDA feedback on Phase 3 development plans.Use template →Breakthrough Therapy Designation RequestA template for documenting preliminary clinical evidence supporting Breakthrough Therapy designation.Use template →RMAT Designation RequestA template for regenerative medicine products seeking Regenerative Medicine Advanced Therapy designation.Use template →Regulatory Strategy DocumentA template for defining regulatory pathways, submission milestones, agency interactions, and risk mitigation plans.Use template →Risk Management Plan (RMP)A template for identifying, evaluating, and mitigating product safety risks throughout development.Use template →Development Safety Update Report (DSUR)An ICH E2F-aligned template for annual safety reporting during clinical development.Use template →Pharmacovigilance PlanA framework for defining safety monitoring activities and post-authorization surveillance strategies.Use template →Benefit-Risk Assessment ReportA structured template for evaluating the overall benefit-risk profile of an investigational product.Use template →Quality Target Product Profile (QTPP)An ICH Q8-aligned template for defining desired quality characteristics of a pharmaceutical product.Use template →Comparability Assessment ReportA template for evaluating the impact of manufacturing changes on product quality, safety, and efficacy.Use template →Technology Transfer PlanA framework for transferring manufacturing processes between development and commercial facilities.Use template →Validation Master PlanA template for planning qualification and validation activities across manufacturing and quality systems.Use template →
Academic
20 templates
Research PaperA structured template for drafting scholarly articles using the standard IMRaD (Introduction, Methods, Results, and Discussion) format.Use template →Systematic ReviewA template aligned with PRISMA 2020 guidelines for conducting and reporting systematic reviews.Use template →Grant ProposalA template for preparing competitive research funding applications in accordance with common sponsor requirements.Use template →Literature ReviewA framework for organizing, analyzing, and synthesizing existing research on a specific topic.Use template →Scoping ReviewA template aligned with PRISMA-ScR for mapping evidence and identifying research gaps.Use template →Research ProposalA structured template for developing study objectives, methodology, timelines, and funding justifications.Use template →Meta-AnalysisA PRISMA-compliant template for synthesizing and statistically analyzing findings from multiple studies.Use template →Master's ThesisA university-style template for organizing thesis research, methodology, findings, and conclusions.Use template →Doctoral DissertationA comprehensive template for preparing a PhD dissertation following academic and institutional standards.Use template →Conference PaperA template designed for submitting research findings to academic conferences and proceedings.Use template →Conference PosterA structured layout for presenting research findings in a concise, visual academic format.Use template →Case Study ReportA template for documenting and analyzing individual cases using established academic reporting practices.Use template →Qualitative Research ReportA template aligned with COREQ reporting guidelines for qualitative studies.Use template →Observational Study ManuscriptA manuscript template aligned with STROBE reporting guidelines for observational research.Use template →Randomized Controlled Trial ManuscriptA manuscript template aligned with CONSORT 2025 guidelines for reporting randomized trials.Use template →Diagnostic Accuracy StudyA reporting template aligned with STARD guidelines for diagnostic accuracy research.Use template →Economic Evaluation StudyA template aligned with CHEERS 2022 guidelines for health economic evaluations.Use template →Clinical Practice GuidelineA template following GRADE methodology for developing evidence-based recommendations.Use template →Data Management PlanA template for documenting data collection, storage, sharing, and preservation practices.Use template →Ethics ApplicationA structured template for preparing submissions to Institutional Review Boards (IRBs) or Ethics Committees.Use template →
Grants
12 templates
NIH R01 Grant ApplicationA template aligned with NIH R01 requirements for preparing investigator-initiated biomedical research grant proposals.Use template →NIH R21 Exploratory Grant ApplicationA template for developing early-stage, high-risk/high-reward research proposals in accordance with NIH R21 guidelines.Use template →NIH SBIR Phase I ApplicationA structured template for preparing NIH SBIR Phase I applications focused on feasibility and proof-of-concept studies.Use template →NIH SBIR Phase II ApplicationA template for developing NIH SBIR Phase II proposals that support further technology development and commercialization.Use template →NIH STTR ApplicationA template aligned with NIH STTR requirements for collaborative research projects between small businesses and research institutions.Use template →NIH Fast-Track SBIR/STTR ApplicationA template for preparing combined Phase I and Phase II applications for accelerated technology development.Use template →Investigator-Initiated Clinical Trial GrantA template for preparing NIH and federal clinical research funding applications, including study design, endpoints, and feasibility plans.Use template →Translational Research Grant ApplicationA framework for seeking funding to advance preclinical discoveries toward clinical development and commercialization.Use template →Rare Diseases Research GrantA template for preparing proposals focused on therapies, diagnostics, or biomarkers for rare and orphan diseases.Use template →Cancer Research Grant ApplicationA structured template for oncology-focused funding proposals covering scientific rationale, study design, and translational impact.Use template →Biomedical Innovation Grant ApplicationA template for presenting novel therapeutic, diagnostic, or platform technologies to U.S. funding agencies.Use template →Small Business Commercialization PlanA template aligned with NIH SBIR/STTR requirements for documenting market opportunity, regulatory strategy, and commercialization plans.Use template →
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Template builder · Clinical Study Protocol
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87% less drafting and review time per CSR section.
A biopharma team developing CAR-T cell therapy for AML compared ProWriter with its in-house workflows, manual drafting and a generic AI tool, across five ICH E3 CSR sections. Each section was timed from reference gathering to hand-off for CMO sign-off, human review included.
- Median reduction in time per section vs. manual drafting
- 87%
- Median reduction in time per section vs. manual drafting
- Median time per section with ProWriter, vs. 4.25 hours manually
- 27 min
- Median time per section with ProWriter, vs. 4.25 hours manually
- Approximate reduction vs. a generic AI tool (about 1.5 hours per section)
- ~70%
- Approximate reduction vs. a generic AI tool (about 1.5 hours per section)
- Redaction needed. The generic AI tool workflow took 15 minutes to 5 hours per document.
- 0
- Redaction needed. The generic AI tool workflow took 15 minutes to 5 hours per document.
One company, five CSR sections, March 2026; four participants (the client's CMO, senior and associate medical writers, plus a ProWriter medical writer, who drafted the ProWriter versions). The client's senior medical writer ran QA/QC and the CMO signed off every version. Not a controlled trial. Redaction time is excluded, and generic AI tool times are approximate, as reported by the client's team. Customer name withheld on request.
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