Partnerships 2010: Site Management Contracting: How to Best Define Responsibilities between Sponsors and CROs to Avoid Accountability Disputes

Panelists: Christina DiArcangelo, Associate Director, Clinical Contracts and Outsourcing, FIBROGEN
Lauren Goldsmith, Senior Manager, Strategic Outsourcing, MANNKIND CORPORATION
Eric Strait, Senior Manager, US Site Contracts, Pharma Development Operations, GENENTECH, INC

A number of key elements were discussed when defining the roles and responsibilities of the CRO and the sponsor. The key to this interaction is the upfront work (face to face meetings, kick off meetings) that addresses the specifics of each group’s roles in the development process.

Accountabilities for each partner have to be clearly defined at the outset and if there is a shift in the responsibilities, further meetings are needed.

Sponsors should have a clear fallback position with stated parameters in the Clinical Trial Agreement (CTA). In addition, they should have a concise negotiation plan which stipulates the CRO’s expectations. Mutual expectations are paramount to a good working relationship. The use of CTA templates makes the process much easier should changes need to be made.

CROs should have a clear plan of action that includes how they will complete the project within the agreed upon study timelines.

Both groups will need to be united when dealing with sites so as to not cause any confusion for site staff.

In addition to the defined roles of each party, there should be standard process document that needs to be ratified with the CRO for each study. This document should state clearly which party is responsible for the involved contracts/budgets and that these amounts are final as written. In the event there is a problem/snag on the CRO side, flexibility is needed to respond quickly to the situation.

There should be a clear escalation plan that sets the guidance as to scope of the decision making authority and to know who the decision makers are.

With respect to budgets and payments, there were some Do’s and Don’ts provided.

Do’s

Write down the payment terms

Include expectations for one-off payments
Create payment contact lists for each site
Ensure proper reporting occurs with respect to escrow accounts for investigator payments and to have a 30% trigger
Agree on reconciliation plan
Always know where payments are during the study.

Don’ts

Keep sites in the dark about where and how payments will be generated
Adjust budgets during negotiations
Pay late

Other recommended considerations were:
Have specific metrics in the contract for turnaround times concerning CTA generation/execution
Do include your legal department in the development of a study specific template
Create workflow and escalation paths
Be aware of what was negotiated previously with repeat sites
Do understand the difference between business and legal issues. There have been instances in the past where the CRO has sent business questions to legal and legal questions to business people.

Use Master Service Agreements (MSAs) from sponsors when utilizing academic sites or SMOs. The sponsor will need to communicate to the CRO what sites on the study have a MSA in place so that the CRO can plan accordingly.

There was discussion concerning payment triggers and the managing of the payment expectations. The details of the arrangement should be clearly outlined in writing that include all payment terms. Escrow accounts should have a 30% draw down trigger, account reconciliation should occur during the study rather than at the end of the study, milestone payments should be clearly defined based upon agreed performance standards and to use a CTMS system where possible.