Sponsor Oversight · page 1 Sponsor Oversight. Gertrud Koefoed Rasmussen, Director Clinical...
-
Upload
nguyenlien -
Category
Documents
-
view
217 -
download
0
Transcript of Sponsor Oversight · page 1 Sponsor Oversight. Gertrud Koefoed Rasmussen, Director Clinical...
page 1
Sponsor Oversight
Gertrud Koefoed Rasmussen, Director Clinical Operations, Zealand Pharma
Zealand Pharma A/S
page 2page 2
Disclaimer:
Zealand Pharma A/S
The presentation reflects the presenter’s own opinions and is not necessarily the opinion of Zealand Pharma.
page 4page 4
Agenda
Zealand Pharma
Oversight Definition Multidisciplinary discipline Selection and qualification Contracting Risk assessment Vendor oversight Trial oversight
Zealand Pharma A/S
page 6page 6
Zealand Pharma – brief background
- Clinical Development - Medical Project Directors (4)- Statisticians (2)- Clinical Operation (10)
- Fully outsourced model- Protocol writing to Report- Clinical CRO- Safety (Pharmacoviglance CRO)- Speciality labs- Data Standards CRO
- Clinical Trial portfolio- Phase 1 – speciality CROs- Phase 2/3 – rare indications / smaller patient populations- Around 15 trials in preparation to reporting
Zealand Pharma A/S
page 8page 8
Oversight – a multidisciplinary activity
- From the beginning to the end - Relevant functions / available functions:
- Trial management- Medical / Safety- Statistic- Data Management- Clinical Trial Supplies- Bioanalysis
- Varying level of involvement
Zealand Pharma A/S
page 9page 9
Oversight - CRO Selection and Qualification
- Request for Information / Request for proposal- Who is invited:
- Previous experience?- Expertise
- Development of RFP material- Specific (multiple input)- Proposed responsibility split
- Review of proposals /bid defense meeting- Scoring / criteria for evaluation
- Assessment report /audit- AwardZealand Pharma A/S
Challenges:When working with new CROs• review of procedures /
SOPs upfront?• Defining specific
requirements• Timing of audit
page 10page 10
Oversight – contractual obligations/responsibility split
Contractual set-up- Letter of intent
- Tasks performed under LOI- Responsibility split
- MSA + work order- Standalone contracts
Zealand Pharma A/S
Challenges:- Evolvement of
responsibility split- Specificity of
responsibility split
page 11page 11
Oversight – risk assessment management
Zealand Pharma A/S
- Vendor oversight- Trial oversight
page 12page 12
Oversight – vendor oversight /review
Vendor oversight plan- One vendor – one plan- Across activities / trials- Focused on risk assessment- Performance rating
Zealand Pharma A/S
page 13page 13
Oversight - Trial Oversight Plan
Purpose:- To ensure that vendors meet their contractual obligations in terms of quality and timelines(and budget)
Trial focus – trial specific- Risk Assessment
- Joint risk assessment with the Clinical CRO- Internally performed risk assessment
Trial specific plan- Developed by the ‘clinical trial team’ – driven by the Clinical trial manager- Overview of all vendors involved/delegated in the trial
Zealand Pharma A/S
page 14page 14
Trial Oversight Plan - contentTrial risk management plan- Trial specific risks – not all generic
risks- Grading of risks – mitigation of risksOversight activities:
Review and approval of plans e.g.- Study plan/trial management
plan/communication plan- Monitoring plan - Protocol deviation categorization- TMF plan- SAPInvolvement in training- Review of CVs and approval - Trial specific training- Site visits
Zealand Pharma A/S
Ongoing review- Procedure / protocol deviations- TMF oversight- Monitoring reports / co-
monitoring- Regular team meetings with
CRO (Status, timelines, ADI, Risks)
- Review of data (CRFs/reports)- Safety reviews
Review and approval of key documents- Protocol- Coding, DBL etc.- CTR
page 15page 15
Documentation of Oversight
- Review and approval of documents- Meeting minutes, ADI (actions, decisions, issues) logs, Risk management- Review logs- Correspondence- Oversight reports
Zealand Pharma A/S
Challenges- finding a middle ground
where sponsor has sufficient data to be confident in the services being provided by the CRO and the conduct of the trial while not doing double work/ micromanagement
- Setting the bar – how to define the extent of review
- How to oversight 3rd
parties (CRO subcontractors)
page 16page 16
Conclusions – key messages
• ICH E6(R2) provides a platform for enhancing sponsor oversight. • The guideline invites sponsors to partner with the CROs early to proactively identify the
critical data and risks associated with the protocol• Cross-functional monitoring strategy, hand-in-hand with sponsor oversight – a
multidisciplinary activity• Sponsor need to feel confident via adequate oversight of the CROs. • Balance between confidence/security vs double work/micromanagement• Oversight activities right from the start to the final end
• Selection and qualification of the CRO to ensure that the CRO that has been selected meets the requirements of the sponsor
• Contractual agreements and responsibility splits• Ongoing oversight of the CRO to confirm throughout the study that the CRO continues to
meet the sponsor’s requirements
• A view from a small company –• a pragmatic approach with available internal competencies, • limited technical solutions• CRO partnership is key
Zealand Pharma A/S