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["PHARMASEAL eTMF RFI / RFP Template"]
[]
["Purpose","Use this workbook as the downloadable companion to the guidance article. It is structured to mirror the narrative flow of the article: why structure matters, how RFIs differ from RFPs, what regulators care about, and how to evaluate vendors consistently."]
["How to use","Start with the RFI Lite sheet to shortlist vendors. Move to the Full RFP sheet for detailed evaluation. Use the Scoring Matrix to compare up to three vendors. The Biotech vs CRO sheet helps tailor weighting and questions to your operating model."]
["Narrative alignment","The section order in this workbook matches the article: Vendor & Company Information; Platform Overview; Compliance, Validation & Inspection Readiness; Security, Privacy & Infrastructure; Functional eTMF Capabilities; Implementation & Migration; Service Model & Support; Commercial & Contractual Considerations."]
["RFI vs RFP","RFI = early-stage qualification and shortlisting. RFP = deeper evaluation of functionality, implementation, support, commercials and long-term fit. Not every organization needs every question; adapt the template to your study model, risk profile and internal governance process."]
["Inspection readiness","Keep completed versions of the template, your scoring outputs and vendor notes as evidence of documented due diligence. This helps demonstrate that vendor selection was structured, risk-based and aligned to regulatory expectations."]
["Persona note","Biotech sponsors often prioritise simplicity, oversight of outsourced work and cost predictability. CROs tend to emphasise scalability, sponsor flexibility and operational consistency across multiple studies."]
[]
[]
["Template map"]
["Article section","Workbook sheet","Audience","Primary purpose","Output","Owner"]
["Intro + why structure matters","Start Here","All","Set context and explain why the template exists","Shared understanding","Marketing / Product Marketing"]
["RFI vs RFP","Start Here","All","Clarify when to use each format","Selection pathway","Clinical Ops / Procurement"]
["Core evaluation framework","RFI Lite; Full RFP","All","Shortlist and evaluate vendors consistently","Completed vendor responses","Clinical Ops / QA / IT"]
["How to compare vendors","Scoring Matrix","All","Turn responses into a structured comparison","Weighted scores","Selection committee"]
["Biotech vs CRO considerations","Biotech vs CRO","Persona specific","Tailor questions and weights to the operating model","Persona-specific emphasis","Commercial / Clinical Ops"]

{"sheet":"RFI Lite","index":1,"n_rows":26,"n_cols":8,"rows_kept":26,"cut":false,"hidden":false,"merged":[[0,0,0,7],[1,0,1,7]]}
["RFI Lite"]
["Use this sheet to shortlist vendors using a lighter set of questions before moving to a full RFP."]
["Section","Question ID","Question","Why it matters","Response type","Vendor response","Internal notes","Priority"]
["Vendor & Company Information","V1","Describe your company, ownership structure and focus within regulated life sciences.","Helps establish credibility, stability and fit for regulated clinical trial environments.","Narrative","","","Important"]
["Vendor & Company Information","V2","Summarise your experience supporting sponsors, CROs and hybrid operating models for eTMF.","Shows whether the vendor understands real-world operating models and shared oversight.","Narrative","","","Important"]
["Vendor & Company Information","V3","Provide examples of organisations similar to ours that use your eTMF platform.","Supports relevance and referenceability.","Narrative","","","Important"]
["Platform Overview","P1","Describe your platform architecture, hosting model and release approach.","Explains core system design and how it is maintained over time.","Narrative","","","Important"]
["Platform Overview","P2","Explain how your platform aligns with the TMF Reference Model and common study structures.","Shows fit with accepted TMF organisation practices.","Narrative","","","Important"]
["Platform Overview","P3","Describe how the platform supports sponsor-led, CRO-led and co-managed TMF models.","Tests flexibility for different oversight arrangements.","Narrative","","","Important"]
["Compliance, Validation & Inspection Readiness","C1","Describe your GxP compliance framework for the eTMF platform.","Compliance foundations should be explicit, not implied.","Narrative","","","Must-have"]
["Compliance, Validation & Inspection Readiness","C2","Explain your validation approach, including qualification of releases and change control.","Critical to defensible system use in regulated studies.","Narrative","","","Must-have"]
["Compliance, Validation & Inspection Readiness","C3","Describe audit trail, metadata and document version controls.","These are core controls for traceability and data integrity.","Narrative","","","Must-have"]
["Compliance, Validation & Inspection Readiness","C4","Explain how the platform supports completeness review, quality control and inspection preparation.","Links system use directly to inspection readiness.","Narrative","","","Must-have"]
["Security, Privacy & Infrastructure","S1","Provide details on data hosting, regional availability and infrastructure resilience.","Helps assess operational robustness and hosting fit.","Narrative","","","Must-have"]
["Security, Privacy & Infrastructure","S2","List current information security certifications and assurance reports.","Supports objective review of security controls.","Document","","","Must-have"]
["Security, Privacy & Infrastructure","S3","Explain encryption, authentication and role-based access controls.","Core controls for privacy and controlled access.","Narrative","","","Must-have"]
["Functional eTMF Capabilities","F1","Describe document ingestion options, including bulk upload and metadata capture.","Indicates day-to-day operational efficiency.","Narrative","","","Important"]
["Functional eTMF Capabilities","F2","Explain how users manage QC workflows, reconciliation and completeness tracking.","Core to maintaining an inspection-ready TMF.","Narrative","","","Important"]
["Functional eTMF Capabilities","F3","Describe milestone-based management, dashboards and reporting.","Shows how oversight is operationalised.","Demo","","","Important"]
["Functional eTMF Capabilities","F4","Explain how the platform supports cross-study visibility and portfolio oversight.","Important for scaling across studies.","Narrative","","","Important"]
["Implementation & Migration","I1","Describe your implementation methodology and governance model.","Implementation discipline affects time, risk and adoption.","Narrative","","","Important"]
["Implementation & Migration","I2","Provide indicative timelines for a new study deployment.","Sets realistic expectations for delivery.","Narrative","","","Important"]
["Implementation & Migration","I3","Explain your approach to legacy TMF migration, including validation of migrated content.","Migration is a common source of project complexity.","Narrative","","","Important"]
["Service Model & Ongoing Support","O1","Describe your support model, service hours and escalation paths.","Shows how issues are managed post go-live.","Narrative","","","Important"]
["Service Model & Ongoing Support","O2","Explain how customers receive regulatory updates, release notes and roadmap visibility.","Indicates long-term partnership quality.","Narrative","","","Important"]
["Service Model & Ongoing Support","O3","Describe the roles of customer success, technical support and implementation teams.","Clarifies who owns what across the relationship.","Narrative","","","Important"]

{"sheet":"Full RFP","index":2,"n_rows":38,"n_cols":8,"rows_kept":38,"cut":false,"hidden":false,"merged":[[0,0,0,7],[1,0,1,7]]}
["Full RFP"]
["Use this sheet to collect detailed RFP responses and internal assessment notes."]
["Section","Question ID","Question","Why it matters","Response type","Vendor response","Internal notes","Priority"]
["Vendor & Company Information","V1","Describe your company, ownership structure and focus within regulated life sciences.","Helps establish credibility, stability and fit for regulated clinical trial environments.","Narrative","","","Important"]
["Vendor & Company Information","V2","Summarise your experience supporting sponsors, CROs and hybrid operating models for eTMF.","Shows whether the vendor understands real-world operating models and shared oversight.","Narrative","","","Important"]
["Vendor & Company Information","V3","Provide examples of organisations similar to ours that use your eTMF platform.","Supports relevance and referenceability.","Narrative","","","Important"]
["Vendor & Company Information","V4","Outline your experience supporting inspections involving your eTMF platform.","Indicates inspection maturity and ability to support audit readiness.","Narrative","","","Important"]
["Platform Overview","P1","Describe your platform architecture, hosting model and release approach.","Explains core system design and how it is maintained over time.","Narrative","","","Important"]
["Platform Overview","P2","Explain how your platform aligns with the TMF Reference Model and common study structures.","Shows fit with accepted TMF organisation practices.","Narrative","","","Important"]
["Platform Overview","P3","Describe how the platform supports sponsor-led, CRO-led and co-managed TMF models.","Tests flexibility for different oversight arrangements.","Narrative","","","Important"]
["Platform Overview","P4","Explain your approach to configuration versus standardisation.","Helps assess implementation effort and long-term maintainability.","Narrative","","","Important"]
["Compliance, Validation & Inspection Readiness","C1","Describe your GxP compliance framework for the eTMF platform.","Compliance foundations should be explicit, not implied.","Narrative","","","Must-have"]
["Compliance, Validation & Inspection Readiness","C2","Explain your validation approach, including qualification of releases and change control.","Critical to defensible system use in regulated studies.","Narrative","","","Must-have"]
["Compliance, Validation & Inspection Readiness","C3","Describe audit trail, metadata and document version controls.","These are core controls for traceability and data integrity.","Narrative","","","Must-have"]
["Compliance, Validation & Inspection Readiness","C4","Explain how the platform supports completeness review, quality control and inspection preparation.","Links system use directly to inspection readiness.","Narrative","","","Must-have"]
["Compliance, Validation & Inspection Readiness","C5","Describe your archival, retention and long-term access strategy for TMF records.","Important for regulatory retention obligations beyond study close-out.","Narrative","","","Must-have"]
["Security, Privacy & Infrastructure","S1","Provide details on data hosting, regional availability and infrastructure resilience.","Helps assess operational robustness and hosting fit.","Narrative","","","Must-have"]
["Security, Privacy & Infrastructure","S2","List current information security certifications and assurance reports.","Supports objective review of security controls.","Document","","","Must-have"]
["Security, Privacy & Infrastructure","S3","Explain encryption, authentication and role-based access controls.","Core controls for privacy and controlled access.","Narrative","","","Must-have"]
["Security, Privacy & Infrastructure","S4","Describe disaster recovery, backup and business continuity arrangements.","Tests preparedness for operational disruption.","Narrative","","","Must-have"]
["Security, Privacy & Infrastructure","S5","Outline your approach to GDPR and applicable privacy requirements.","Supports privacy and cross-border data governance.","Narrative","","","Must-have"]
["Functional eTMF Capabilities","F1","Describe document ingestion options, including bulk upload and metadata capture.","Indicates day-to-day operational efficiency.","Narrative","","","Important"]
["Functional eTMF Capabilities","F2","Explain how users manage QC workflows, reconciliation and completeness tracking.","Core to maintaining an inspection-ready TMF.","Narrative","","","Important"]
["Functional eTMF Capabilities","F3","Describe milestone-based management, dashboards and reporting.","Shows how oversight is operationalised.","Demo","","","Important"]
["Functional eTMF Capabilities","F4","Explain how the platform supports cross-study visibility and portfolio oversight.","Important for scaling across studies.","Narrative","","","Important"]
["Functional eTMF Capabilities","F5","Describe standard integrations or APIs for CTMS, eClinical or QMS systems.","Assesses ecosystem fit and data flow.","Narrative","","","Important"]
["Implementation & Migration","I1","Describe your implementation methodology and governance model.","Implementation discipline affects time, risk and adoption.","Narrative","","","Important"]
["Implementation & Migration","I2","Provide indicative timelines for a new study deployment.","Sets realistic expectations for delivery.","Narrative","","","Important"]
["Implementation & Migration","I3","Explain your approach to legacy TMF migration, including validation of migrated content.","Migration is a common source of project complexity.","Narrative","","","Important"]
["Implementation & Migration","I4","Clarify vendor and customer responsibilities during implementation and onboarding.","Prevents ambiguity and resource gaps.","Narrative","","","Important"]
["Implementation & Migration","I5","Describe training and change management support.","Adoption depends on more than configuration.","Narrative","","","Important"]
["Service Model & Ongoing Support","O1","Describe your support model, service hours and escalation paths.","Shows how issues are managed post go-live.","Narrative","","","Important"]
["Service Model & Ongoing Support","O2","Explain how customers receive regulatory updates, release notes and roadmap visibility.","Indicates long-term partnership quality.","Narrative","","","Important"]
["Service Model & Ongoing Support","O3","Describe the roles of customer success, technical support and implementation teams.","Clarifies who owns what across the relationship.","Narrative","","","Important"]
["Commercial & Contractual Considerations","K1","Describe your pricing model, including how cost scales by study, user or portfolio.","Clarifies long-term commercial fit and scalability.","Narrative","","","Must-have"]
["Commercial & Contractual Considerations","K2","Outline implementation, migration and optional service costs.","Prevents under-scoping of total cost.","Narrative","","","Must-have"]
["Commercial & Contractual Considerations","K3","Describe standard contract terms, data ownership and exit provisions.","Important for governance and long-term control.","Narrative","","","Must-have"]
["Commercial & Contractual Considerations","K4","Explain how customers access and export their data at contract end.","Supports portability and business continuity.","Narrative","","","Must-have"]

{"sheet":"Scoring Matrix","index":3,"n_rows":15,"n_cols":9,"rows_kept":15,"cut":false,"hidden":false,"merged":[[0,0,0,8],[1,0,1,8],[13,0,13,8],[14,0,16,8]]}
["Scoring Matrix"]
["Use this sheet to compare up to three vendors. Enter a score from 1 (poor) to 5 (excellent) for each category. Weighted scores calculate automatically."]
["Category","Suggested weighting","Evaluation guidance","Vendor A score","Vendor A weighted","Vendor B score","Vendor B weighted","Vendor C score","Vendor C weighted"]
["Vendor & Company Information",0.1,"Credibility, relevant experience and inspection maturity.",null,{"$f":"B4*D4","v":0},null,{"$f":"B4*F4","v":0},null,{"$f":"B4*H4","v":0}]
["Platform Overview",0.1,"Architectural fit, TMF model alignment and configurability.",null,0,null,0,null,0]
["Compliance, Validation & Inspection Readiness",0.2,"The most critical area for defensible use.",null,0,null,0,null,0]
["Security, Privacy & Infrastructure",0.15,"Security posture, resilience and privacy governance.",null,0,null,0,null,0]
["Functional eTMF Capabilities",0.2,"Operational fit for document management and oversight.",null,0,null,0,null,0]
["Implementation & Migration",0.1,"Delivery realism, migration risk and onboarding support.",null,0,null,0,null,0]
["Service Model & Ongoing Support",0.1,"Quality of long-term support and partnership.",null,0,null,0,null,0]
["Commercial & Contractual Considerations",0.05,"Scalability, ownership and contractual fit.",null,0,null,0,null,0]
["Total weighted score",1.0,null,null,{"$f":"SUM(E4:E11)","v":0},null,{"$f":"SUM(G4:G11)","v":0},null,{"$f":"SUM(I4:I11)","v":0}]
[]
["Selection note"]
["Use this space to capture the rationale for shortlisting or selection, any material risks, and actions required before contract signature."]

{"sheet":"Biotech vs CRO","index":4,"n_rows":8,"n_cols":5,"rows_kept":8,"cut":false,"hidden":false,"merged":[[0,0,0,4],[1,0,1,4]]}
["Biotech vs CRO Considerations"]
["Use this sheet to tailor the template to the operating model. The guidance mirrors the article's persona section and can be adapted as a cover page or internal alignment tool."]
["Theme","Biotech sponsor emphasis","CRO emphasis","Suggested sections to weight up","Practical note"]
["Adoption model","Ease of use, speed of deployment and low admin burden.","Consistency across multiple sponsors and studies.","Platform Overview; Implementation & Migration","Biotech teams often need faster time-to-value with lean internal resources."]
["Oversight","Visibility into outsourced activities and sponsor/CRO roles.","Role clarity across sponsor teams with standard operating models.","Functional eTMF Capabilities; Service Model & Support","Both models need oversight, but the point of control differs."]
["Inspection readiness","Practical, built-in support for completeness and QC from day one.","Repeatable inspection readiness at scale across a portfolio.","Compliance, Validation & Inspection Readiness","Use this to adjust scoring guidance and demos."]
["Commercial fit","Predictable cost as the pipeline grows.","Scalable commercials across multiple studies and sponsor requirements.","Commercial & Contractual Considerations","Commercial models should match expected portfolio growth."]
["Operational efficiency","Simple workflows that do not require specialist resources.","High-volume ingestion, standardisation and efficient reconciliation.","Functional eTMF Capabilities","Operational priorities should be reflected in the demo script."]