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Inspection Readiness at a Start-up: Case Study
Donna W. Dorozinsky President & CEO Just in Time GCP
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Situation - December Team Small Start up 3 Studies
1 Regulatory 4 Clinical 1 Medical Officer 3 Studies NDA planned for March Get us Inspection Ready Situation - December
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Protocol #1 Pivotal trial with DBL planned for end of January
Change in CRO with migration of database (CRO A) Subsequently 2 CROs due to delayed enrollment CRO B – US sites and RoW, biometrics CRO C – US sites TMF TMF from original CRO with sponsor on CDs Both add on CROs holding their TMF Content in eTMF 1200 documents between the 2 TMFs Sponsor held some TMF content on shared drives, s, etc Vendor content held by vendors ePRO used for primary endpoint Issue with configuration for eligibility requiring manual calculation of eligibility for a period of time
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Protocol #2 Pivotal trial with database locked in October of that year
2 CRO CRO B – US sites and RoW, biometrics CRO C – US sites TMF Both CROs holding their TMF Content in eTMF 1800 documents between the 2 TMFs Sponsor held some TMF content on shared drives, s, etc Vendor content held by vendors
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Protocol #3 Open Label Extension
Not all subjects rolled from #1 & #2 protocols Study was active and would be active at time of NDA filing Only CRO C for this study, added biometrics responsibilities Sponsor held some TMF content on shared drives, s, etc TMF CRO holding their TMF Content in eTMF 600 documents between the 2 TMFs Vendor content held by vendors
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Identifying Risks 3 studies with large gaps in TMF Content
Change in CRO & subsequent database transfer General CRO oversight – TMF oversight gaps Sponsor Content Identifying Risks
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Overall Strategy Focus on anticipated BIMO Activities
Understand the Story Make sure the TMF tells the Story Engage CRO as partners in remediation Continue to have CROs hold TMF for inspection
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Prioritization Remediate TMFs Storyboards Change in CROs
Database Transfer CRO Oversight Sight Selection ePRO issues TMF Oversight
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TMF Remediation Completeness of CRO TMFs
Data Integrity of Transferred TMF Content Completeness and security of sponsor content TMF Remediation
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CRO Completeness Met with each CRO to discuss TMF Gaps
Developed Inspection Readiness Plan for each CRO Weekly meetings with CRO to track progress Identified high level gaps – essential documents Protocol training CoV document for both protocol #1 & #2 Monitoring Visit documents CROs had 60 days to clean up TMF As CROs reported a site’s file as complete, sponsor performed completeness review and issued queries – immediately identified trend in gaps Continued weekly meetings until fully remediated Established TMF Map to identify content location
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Sponsor Content – CD from CRO & Sponsor Generated
Implemented sponsor eTMF Met with 2 vendors Implemented selected vendors standard configuration with minor changes Developed Change Management SOP to govern implementation Implementation took 12 weeks Upload all sponsor content to eTMF High number of documents related to the changes in CRO and transfer of database Sponsor Content – CD from CRO & Sponsor Generated
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Storyboards During period of time that CROs were collecting gap content, worked to establish storyboards to help identify sponsor content Searched s of 4 team members and one individual who had left during the study Reconstructed key events with documentation we found Utilized pseudo “risk tracker” that study lead had maintained.
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Outcome Inspection in September with over 40,000 documents between the 3 TMFs Inspector wanted paper Full remediation following inspection
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Thank you! Donna Dorozinsky ddorozinsky@justintimegcp.com
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