Exploring the Importance of Instilling a Sense of Ownership in the Vendor and Making Them Feel Involved and Motivated Through the Trial Cycle

Transcription

1 Exploring the Importance of Instilling a Sense of Ownership in the Vendor and Making Them Feel Involved and Motivated Through the Trial Cycle Natasha Sabljic November 14, 2012 Outsourcing in Clinical Trials 1

2 Overview Know What You Need Find the Right Match Build a Solid Foundation Grow and Nurture Relationship For Better or For Worse Q & A 2

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4 Know What You Need Understand your project needs and internal capabilities Establish realistic objectives and expectations Identify potential matching providers Create and deliver RFI/RFP to potential bidders, allow appropriate time for review, questions, and bidders response 4

5 Finding the Right Match Characteristics to look for in CRO: Expertise Capability Quality Record Competent Pricing Compatibility Customization Strategic fit 5

6 Finding the Right Match Bid defense meeting is an opportunity to assess if there is a match in characters and culture Does size of CRO matter? It might. The right fit will depend on the needs of the trial at hand and overall development plan. Engage executive management and get both agreement and commitment 6

7 Building a Solid Foundation Getting to Know each other: Promote collaborative environment Actively seek CRO s perspective on the study plan and protocol Going into the project with shared vision and sense of accountability is vital for CRO s commitment 7

8 Building a Solid Foundation Getting to Know each other: 8

9 Building a Solid Foundation Discuss and collaboratively define: Roles and responsibilities Communication plan Escalation pathways Decision-making strategy Reporting expectations Performance metrics Issue resolution process (contingency/risk management plan) Budget management Change order process 9

10 Building a Solid Foundation Whenever possible allow the CRO to take advantage of its processes Treat each relationship as if it has long-term potential Treat your CRO as an asset 10

11 Building a Solid Foundation Kick-Off meeting Aim for face-to face type meeting Include the third party staff and the support personnel who will be involved routinely Ensure all members from internal team get a chance to speak to their counterpart on the CRO team 11

12 Grow and Nurture Relationship Communicate, communicate, communicate! Provide your CRO with a contact list of all key internal and, if applicable, third party personnel up front Ensure that communication pathways are maintained between all parties at all times Share all important information with your CRO in a timely manner 12

13 Grow and Nurture Relationship Be consistent Be accessible Provide meaningful feedback Keep your commitments Listen to and acknowledge validity of concerns raised by CRO 13

14 Grow and Nurture Relationship Use technology whenever possible to monitor study status Find balance between hands off and hands on management approach Grow a strong unified project team by maintaining respectful environment and sense of trust, belonging and contribution 14

15 Grow and Nurture Relationship Stuff happens fix it and maintain flexibility and good faith. Do not point fingers. Instead, address any issues or concerns as soon as they arise in a spirit of a mutual responsibility and accountability. 15

16 Grow and Nurture Relationship Expect the best and show you care Recognize, thank, and otherwise motivate outstanding performers Set small goals and give verbal kudos or small, tangible rewards. Note: People are more committed to projects they do with people they like and respect. Source: Meeting the Challenges in Outsourcing Clinical Research to CROs, Kasper P., Monitor, June

17 For Better or For Worse Risk sharing Operational risk Bonus/Malus model Fixed-price model Compound risk Financial Risk 17

18 For Better or For Worse Operational Risk Sharing CRO compensation is performance driven according to the achievement of pre-defined milestones and deliverables Both parties are aware of expectations and have incentives to work more efficiently Bonus/Malus model: timely or early achievement of each milestone triggers a bonus payment, whereas late deliverables trigger a reduction in the payment, pro-rated on when the milestone was actually achieved Source: More than Money, Dietlin T., Samedan Ltd,

19 For Better or For Worse Operational Risk Sharing CRO is rewarded for over-performing and penalised for under performing Creation of a joint reward system by aligning internal team incentives with those of CRO Bonus might be cash or take other forms including stock options 19

20 For Better or For Worse Operational Risk Sharing Fixed-price model: the CRO and sponsor agree to a fixed price for a project, and no additional expenses are passed onto the sponsor unless the project specifications are changed The sponsor benefits from knowing how much a trial will cost from the start, while the CRO is motivated to move and complete the project quickly to maximise its own profit. Source: More than Money, Dietlin T., Samedan Ltd,

21 For Better or For Worse 21

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23 Questions and Answers 23

24 References Evolving Tactical Relationships Into Global Partnerships, Townshend A, & lauf I., Contract Parma, May 2012 Five Tips for Working Relationship Between a Sponsor and CRO, Habita C., January 2011 Meeting the Challenges in Outsourcing Clinical Research to CROs, Kasper P., Monitor, June 2012 More than Money, Dietlin T., Samedan Ltd, 2010 Sponsor-CRO Relationships: Managing Risk, Thompson B.M., EpstainBeckerGreen, February 2008 Success and Failure in the Sponsor-Vendor Partnership, Bassion S., Clinical Research 24