Monday, September 5, 2016

Managing Mutual Expectations – Persistent Challenges in a Mature Industry

Since the emergence of the first contract research organizations (CROs) 35 years ago, outsourcing has become an integral and indispensible aspect of clinical development. The contract research industry is considered mature. Best practices for cooperation have been developed on both sides of the Sponsor–CRO interface. Many Sponsor companies have dedicated CRO management departments, and most CROs have dedicated client relationship managers. Against this background, you would not expect too many surprises at the interface during a Sponsor-CRO collaboration. 

Nevertheless, when I ask Sponsor representatives to rate their experience of working with CROs as positive or challenging, the most frequent reply is “it depends”. The factors underlying this perception vary widely. “It depends on the CRO company” may not sound unreasonable. However, even when working with the same CRO, and despite the considerable efforts towards harmonization and standardization over the last 35 years, the level of Sponsor satisfaction still appears to depend on factors such as individual CRO project team members, the location of the CRO affiliate office, or the nature of the services outsourced. Many Sponsor employees have come to accept outsourcing as an inevitable fact of their working lives, while their enthusiasm for working with CROs remains muted. Most likely, on the other side of the interface, CRO employees have similar thoughts.

But why, in a mature industry, has the collaboration between the companies discovering innovative medications, and the expert organizations essential for their development, not become a routine, if not enjoyable process?

Frustrated expectations are among the top causes for mutual dissatisfaction in a collaboration. On both sides of the interface, you will find individuals at work, often harbouring highly individualistic expectations. Over and above the deliverables specified in a contract, Sponsor expectations include a range of less well defined elements, such as flexibility, transparency, client-oriented behaviour, solutions to emerging challenges, accountability and ownership, after-hours availability, competitive pricing, and access to experts across the globe at short notice.

CROs, even though they are service providers, also have expectations. These include Sponsor trust, responsiveness, precise instructions, team work, reliability, realistic planning horizons, patience and understanding when performance is not perfect, respectful communication, restraint from micromanagement or recognition for work well done. 

We can safely assume that neither CROs nor Sponsor companies deliberately set out to disappoint each other, and there are two main reasons why expectations are still not met: First, the expectation was not communicated, at least not specifically, unambiguously and in sufficient time. Second, the expectation was simply not realistic.

Clearly, Sponsors are entitled to expect client-oriented behaviour, solutions to emerging challenges, or accountability and ownership. But exactly how do you define “flexibility” or “transparency”, and how realistic is the availability of experienced staff “at short notice”, and at a “competitive” price?
From the CRO point of view, expecting the Sponsor to be responsive, and to provide precise instructions and reliable information, is entirely reasonable. Trust and recognition, however, need to be earned, while patience and understanding is possibly too much to expect from a Client paying a substantial amount for an agreed service.

In practice, the key question is whether both Sponsor companies and CROs invest sufficient time and thought, from the outset, to precisely and unambiguously define, discuss and agree their mutual expectations.

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CROs and their employees, often working at the limit of their capacity for a multitude of Clients, still need to remain aware that, for every Sponsor, their trial is of central importance, with a critical impact on the success, or even survival, of the company. They need to listen closely, and understand, each Sponsor´s expectations, regardless of whether these are standard or not. At the same time, they should be encouraged, both by their own management and by their Clients, to address any expectations which they clearly regard as unrealistic. 

At the same time, Sponsor employees need to fully accept that their CRO colleagues also have legitimate and well-founded expectations regarding the cooperation. Sponsor Companies have different and distinctive personalities, and CRO teams require and deserve guidance in order to understand these. As in any successful relationship, mutual expectations need to be clear, and mutually respected. Both sides must be open and honest as to what is, and is not, possible.

Precisely defining, openly discussing and honestly agreeing expectations, not only at the bid defense and kick-off meetings, but throughout a project, is the foundation for any successful collaboration. There will continue to be many surprises during the course of clinical trials. With professional expectation management in place, the Sponsor-CRO interface should not be the primary source. 

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