Outsourcing

Increasing Transparency and Building Relationships between Sponsors and CROs

Outsourcing

09:37, June 7 2018

image

Jacqueline Mardell, VP Clinical Operations, Ascendis Pharma, examines ways in which sponsors and CROs can work together more seamlessly

“All CROs are the same,” my CMO said to me shortly after I joined a new pharma company. “They all say great things but you can’t count on them to deliver. I wish we still had our own study teams filled with CRAs and assistants and…” – his voice trailed off wistfully as he remembered the glory days of clinical operations departments well-stocked with fully trained staff delivering concierge site management services. I remember those days too and I sympathize, but as we all know, clinical trial management has left that era some time ago, and in its place most pharma and biotech companies have trimmed down our in-house resources to become increasingly dependent upon the services of external resource providers, such as full-service CROs, with varying degrees of success.

I have written in these pages several times before about the relationship between the sponsor and CRO, including suggestions for vendor qualification, how to repair broken relationships, and even some thoughts for rescuing or replacing a CRO mid-study. Now let’s identify the next step in the process, to establish true partnership relationships between sponsors and CROs in such a way that fosters trust between parties, a boundary-less team from both entities who are trained on common processes and work together transparently for the good of the study and the participants.

Expand our Thinking Beyond the Transactional

Typical sponsor-CRO relationships are a series of protracted transactions. After a lengthy request for proposal (RFP) and proposal review process, the sponsor selects two or more CROs to invite for a bid defense. During the defense, which may (or may not) include some of the actual proposed team members (subject to change), sponsors have a chance to ask questions and assess whether a relationship can be formed. After picking a winner, more time passes while a contract is hammered out in a back and forth exchange of track-change documents.

The study is finally conducted with the actual CRO team who may (or may not) have been introduced at the bid defense, and after a period of evaluation whose results may (or may not) be shared with the CRO for process improvement, the sponsor is already preparing the RFP letters to go out to a list of CROs for the next study. Lather, rinse, repeat. The cycle is exhausting and time-consuming, CRO team members struggle to understand the needs of the study or their role on the team, trust issues are left unaddressed, and everyone ends up dissatisfied with the entire enterprise.

Breaking this cycle requires a different way of looking at the problem and moving from a relationship defined by transactions to one characterized by a partnership agreement. The Business Dictionary defines partnership as an organization “in which two or more {parties} pool money, skills, and other resources, and share profit and loss” under the terms of an agreement, or where “the participants in an enterprise agree to share the associated risks and rewards proportionately.”

Characteristics of the Most Successful Partnerships

According to the Vantage Partners “Sponsor-CRO Collaboration Study” published in May 2013, more sponsors are venturing into the world of partnerships with one or more CROs, also including specialty services like data management or central labs. These relationships may be characterized by formal governance structures, strategic and operational integration of work forces, joint investment in common systems and training, and a long-term commitment to working together.

Surveys of organizations employing partnership models reveal that the characteristics of the most successful partnerships include:

  • Acknowledging and leveraging differences (priorities, business models, etc.) rather than working against them
  • Having a joint mentality of “we are all colleagues”
  • Sponsors providing a high degree of transparency into development plans allowing for earlier engagement in the lifecycle
  • Having a set of well-defined processes, policies procedures, and training applicable to all the individuals on the joint team, and
  • Having team and individual roles and responsibilities clearly defined

These attributes foster early detection of potential problems and provide an environment in which root cause analysis and problem solving are encouraged and rewarded.

Successful partnerships between sponsor and CROs are characterized by much more than language in a full service model master services agreement. They must also include soft factors such as attitudes, business philosophy and behavior of the individuals from each of the parties. In this way a partnership between sponsor and CRO often spring out of the relationship between the principals of the individual entities, because they will have already learned that they are “inside each other’s heads” and can reliably predict how the other will respond in various situations. The trust in this relationship is what the two principals want to further within the ranks of their respective organizations, because they see the value to their studies, and therefore to their balance sheets.

How to Evaluate the Partnership

The most successful of these partnerships use some or all of the following tools to manage the relationship and assess the efficiency of the joint study team:

  • Active and continuing management of the trial scope and budget, between the quarter closes
  • Aligned joint SOPs and training for the team
  • Robust, multi-level governance system up and down the organization
  • A two-way scorecard for both parties to evaluate the team’s performance with both hard and soft factors, such as performance to budget and timeline, level of trust, ability to problem-solve and innovate as a team
  • Investment in change management to foster a new way of seeing each other

Study management and performance problems such as high turnover, “blame and shame” behaviors, and missed deadlines can be related directly to sponsor/CRO relationship problems: either a dysfunctional one or none at all. Building a relationship that is strong enough to support a high-functioning and lasting team takes time and a lot of work by the principals of both parties. Further, it requires both similarities as well as complimentary differences, and the awareness that an investment in capital and team members can yield a built-for-purpose study team that works seamlessly as a unit. Sponsors and CROs who invest in a strategic partnership with the characteristics described here report fast, more cost-effectively run studies, and they attribute those successes to the partnership.

 

References and Further Reading:

Vantage Partners, “Sponsor-CRO Collaboration Study”, (May 2013), https://bit.ly/1ExYp9x

"Strategic Partnerships 2013, Transforming and Unlocking Value in Biopharmaceutical Development," based on third-party research released by Parexel, (April 2013), http://www.parexel.com/etc/strategic-partnerships-report-2013/

ISR Reports, "2013 Phase II/III CRO Quality Benchmarking Report," (April 2013), http://www.isrreports.com/product/2013-cro-quality-benchmarking-phase-iiiii-service-providers/

The Avoca Group, "Quality Consortium, Summit 2013, Optimizing Approaches and Establishing Best Practices in Quality Management of Outsourced Clinical Research, Executive Summary Report," (June 2013), http://www2.theavocagroup.com/content/documents/files/Summit_2013_Executive_Summary1.pdf

Comments

Post a comment

Comments may be moderated for spam, obscenities or defamation.