{"title":"CRO Oversight \u0026 Governance","description":"\u003cp\u003eThe accountability is yours whether you look or not. These are the tools for looking: oversight plans, KPI\/KQI scorecards, transfer-of-responsibility checklists.\u003c\/p\u003e","products":[{"product_id":"ich-e6r3-kit-02-oversight-audit-capa","title":"E6(R3) Sponsor Kit 02 — Oversight, Audit \u0026 CAPA","description":"\u003cp\u003eKeeping oversight of work you have handed to someone else, and dealing with it properly when something goes wrong.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e3 procedures, 16 records.\u003c\/strong\u003e R3 makes quality assurance a risk-based strategy aimed at preventing serious noncompliance, not just a set of checks after the fact (3.11.1), and elevates avoiding, detecting and preventing recurrence to a Principle (6.3).\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eSponsor oversight and allocation of activities, with the escalation record\u003c\/li\u003e\n\u003cli\u003eQuality assurance and audit, including the audit response action log\u003c\/li\u003e\n\u003cli\u003eDeviations, noncompliance, root cause analysis and CAPA\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eTwo of the sixteen are new since E6(R2). Seven are scored Critical on the gap assessment, more than any kit except Data Governance.\u003c\/p\u003e\n\u003cp\u003eWord and Excel, editable, no macros. Individual Licence. These are templates, not an approved quality system.\u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47734517629099,"sku":"KA-TK-E6R3-K02","price":1245.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-kit-02-oversight-audit-capa.jpg?v=1788306756"},{"product_id":"ich-e6r3-kit-03-vendor-selection-oversight","title":"E6(R3) Sponsor Kit 03 — Vendor Selection \u0026 Oversight","description":"\u003cp\u003eChoosing a provider, writing down what they are actually responsible for, and proving you checked.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e3 procedures, 13 records.\u003c\/strong\u003e The kit with the most genuinely new ground: \u003cstrong\u003esix of its expectations have no counterpart in E6(R2) at all\u003c\/strong\u003e, and ten are scored Critical. R3 requires a provider's suitability to be assessed and documented \u003cem\u003ebefore\u003c\/em\u003e engagement (3.6.7).\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eVendor agreements and transfer of obligations\u003c\/li\u003e\n\u003cli\u003eTiered provider suitability assessment and the service provider register\u003c\/li\u003e\n\u003cli\u003eBusiness continuity and system outage fallback\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eIf you use a CRO and have never written down which duties moved and which stayed, start here.\u003c\/p\u003e\n\u003cp\u003eWord and Excel, editable, no macros. Individual Licence. \u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47734524674219,"sku":"KA-TK-E6R3-K03","price":1395.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/ich-e6r3-kit-03-vendor-selection-oversight.jpg?v=1788306867"},{"product_id":"rfp-template-cro-selection","title":"RFP Template — CRO Selection","description":"\u003cp\u003eThe request-for-proposal package we use to put CROs on a level playing field, so the bids you get back are actually comparable.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e23 pages, 12 tables, 19 service areas\u003c\/strong\u003e — priced line by line, from project management and regulatory affairs through to central lab, TMF and translations.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eScope of work and a services matrix each bidder completes the same way\u003c\/li\u003e\n\u003cli\u003ePast performance, financials and organisational structure\u003c\/li\u003e\n\u003cli\u003ePricing, contracts and the assumptions behind the number\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eMost RFPs come back impossible to compare, because every CRO answers a different question and prices a different scope. This one fixes the questions and fixes the line items, so the differences you see between two bids are real differences rather than formatting.\u003c\/p\u003e\n\u003cp\u003eMicrosoft Word (.docx), editable. Free, and yours to keep.\u003c\/p\u003e","brand":"KA Clinical","offers":[{"title":"Default Title","offer_id":47735496376491,"sku":"KA-FR-RFP-001","price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0790\/5243\/9723\/files\/rfp-template-cro-selection.jpg?v=1788314286"}],"url":"https:\/\/www.kaclinical.com\/collections\/cro-oversight-governance.oembed","provider":"KA Clinical","version":"1.0","type":"link"}