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Sponsor Oversight

Gertrud Koefoed Rasmussen, Director Clinical Operations, Zealand Pharma

Zealand Pharma A/S

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Disclaimer:

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The presentation reflects the presenter’s own opinions and is not necessarily the opinion of Zealand Pharma.

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Agenda

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Oversight Definition Multidisciplinary discipline Selection and qualification Contracting Risk assessment Vendor oversight Trial oversight

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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

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Oversight – an ongoing activity

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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

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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

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Oversight – contractual obligations/responsibility split

Contractual set-up- Letter of intent

- Tasks performed under LOI- Responsibility split

- MSA + work order- Standalone contracts

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Challenges:- Evolvement of

responsibility split- Specificity of

responsibility split

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Oversight – risk assessment management

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- Vendor oversight- Trial oversight

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Oversight – vendor oversight /review

Vendor oversight plan- One vendor – one plan- Across activities / trials- Focused on risk assessment- Performance rating

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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

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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

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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

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Documentation of Oversight

- Review and approval of documents- Meeting minutes, ADI (actions, decisions, issues) logs, Risk management- Review logs- Correspondence- Oversight reports

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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)

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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

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Questions?

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