Quality Systems That Work; Contracts

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Quality Systems That WorkContracts

• Dominic Hickman, David Powell, Lisa Giles

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Agenda

• Purpose of the Workshop
• Setting the Scenario
• Role of the Trust
• Legal Perspective
• Implementation of the Contract
• Key Learning's

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RD Guidance on Commercial Management

• RD Offices should be involved at the earliest
  opportunity
• Central liaison with support departments is
  recommended
• RD/Finance will cost the trial
• All trials should have a single agreement signed
  by the Trust (no separate departmental
  agreements)
• Investigator can acknowledge responsibilities but
  is not a party to the agreement
• VAT???

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Philibust

• Sponsor
• Haematology Antibody Technologies (HAT)
• Global CRO to run study
• Study
• Phase III pivotal study
• 300 newly diagnosed CML patients
• 100 EU sites
• 10 UK sites

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Philibust

• Timelines
• Protocol finalised Jan-2005
• Submissions Jan-2005
• Local submissions Feb-2005
• Initiations Mar-2005
• First patient in Apr-2005
• Last patient in Apr-2006
• Driver
• NDA submission

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So Far.

• Dr Smith contacted by CRO feasibility group
• Dr Smith has experience and was contacted by CRA
• A Pre-Study Visit has been conducted
• Dr Smith has confirmed his interest
• CRA has forwarded all the documents to Dr Smith
• Dr Smith has forwarded the contract to the Trust
  RD

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Site Contracts
Challenge Unpredictable Timeline

• What can be done?
• Up-front negotiations
• Agreed issue escalation plan
• Investigator grants finalised
• Contract support group
• Specialists in contract negotiations
• Centralised repository for negotiated templates
• Local contacts database
• Guidance to Sponsor legal representatives
• Quick turn around

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COSTING ISSUES

• Identify procedures that are additional to normal
  clinical practice or charge for everything?
• Setup fees
• Base clinic costs on staff time overhead or
  cost individual procedures
• Charge private patient rates for investigations
  or charge actual cost overhead.
• Profit

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Problematic Contract Issues (1)

• Parties

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Problematic Contract Issues (2)

• Indemnities

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Problematic Contract Issues (3)

• Publication Rights
• Intellectual Property

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Problematic Contract Issues (4)

• Governing Law
• Dispute Resolution

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Implementation of the Contract

• Maintain Indemnification
• Set-up payment schedule and triggers
• Monitor Contract
• Changes in legislation
• Changes in roles and responsibilities
• Changes in timelines
• Changes in enrolment
• Changes in scope

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Legally Binding Document
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Key Learning's

• Local perspective in a global environment
• Up-front planning
• Process implementation
• Monitoring and maintenance