Templates

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.

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Templates

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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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