Life Science Leader Magazine Supplements

CRO Guide 2016

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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SPONSOR-CRO collaboration LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 22 By L. Sundar OPERATIONALIZING COLLABORATION: HOW SPONSOR-CRO DISCONNECTS HOLD BACK CLINICAL TRIAL QUALITY Operationalizing Collaboration: How Sponsor-CRO Disconnects Hold Back Clinical Trial Quality L A K S H M I S U N D A R VP strategy and development, The Avoca Group n recent years, the pharmaceutical industry has been pulled in opposite directions by the historic approaches that have served it well in the past and the new thinking many claim it must adopt to thrive going forward. Advocates of the new approach argue pharma must "bust silos" and forge ever-closer ties with CROs and even rivals. Research conducted by The Avoca Group reveals clear boundaryless communication is a crucial aspect of driv- ing quality in clinical trials. With some silos essential to pharma and an industry built on protecting intellectual property, can we perform precision silo-busting? The argument in favor of eliminating the barriers both within and between organizations is now well into its third decade. Since 1990 when GE first envi- sioned building "a boundaryless company … where we knock down the walls that separate us from each other on the inside and from our key constituencies on the outside," many an article has espoused the monetary and nonmonetary value of breaking down silos for better collabora- tion. Yet businesses in multiple industries are still trying, with varying degrees of success, to achieve this goal. Part of the difficulty stems from the fact that rigid, demarcated structures can be advantageous. When such structures are in place, roles and reporting lines, which are valuable at large organizations, are clear and easily understood. The sprawl- ing global operations of the leading pharma companies and CROs make them prime candidates to benefit from internal silos. As well as contending with these pan-industry issues, large pharma com- panies face a set of challenges specific to drug development. Collaboration is dif- ficult, yet survey data suggests it is some- thing the industry must embrace if it is to eliminate current inefficiencies. DEMONSTRATING THE SPONSOR-CRO DISCONNECT The results of a 2015 Avoca survey of 226 people from sponsors and 202 from CROs illustrate the shortcomings of the current situation. While many sponsors have tried to form closer ties to a small pool of outsourcing partners in recent years, the survey suggests the relationships are yet to mature into the seamless collaborative alliances GE envisioned in 1990. "[Sponsors don't give us] ownership of decisions that we should have. This delays our deliverables which sponsors will hold us accountable for in the end." [CRO] "CROs don't like to problem solve and offer suggestions. They'd rather just do as they are told." [Sponsor] "One sponsor that I work with is new to fully outsourced trials, so at the beginning of our working relationship, they micromanaged us." [CRO] Such struggles are evident in sponsor and CRO perceptions of their own and each other's attempts to create integrated quality management systems (QMS). There is widespread acceptance that an integrated QMS, in which all of the processes and tools work together to ensure clinical trial quality, is of value. Yet when Avoca asked sponsors and CROs about the extent to which they and their partners have integrated QMS, neither group came close to strongly agreeing that such systems are in place. The shortcomings of existing attempts at integrated QMS were one of the few areas of agreement between CROs and sponsors. CROs consistently rated all other aspects of their own QMS highly. Yet when sponsors were asked to rate their CROs' QMS, they gave middling scores across the board. The disconnect in per- ceptions suggests there is a breakdown in communication. If the QMS are as good as CROs think they are, the benefits are not being made clear to sponsors. If the QMS are as flawed as sponsors think they are, the shortcomings are not being conveyed clearly to CROs. There is clear evidence that high levels of sponsor satisfaction are highly correlated to clear articulation of roles and responsibilities in forging strategic relationships between sponsor and CRO. LEARNING FROM OTHER INDUSTRIES In trying to successfully operationalize collaboration, sponsors and CROs can learn from experiments run by their peers and companies grappling with similar problems in other industries. Younger companies, uninhibited by the institutionalized thinking that can take hold over decades, are trying some of the bolder ideas. Facebook, for example, puts each new hire through a six-week boot camp before they join their special- ized teams so as to form bonds between people in different parts of the company. If sponsor and CRO staff went through intercompany bootcamps, would they retain the divergent perceptions that are evident in the survey data? Or would their shared backgrounds lead to a more coherent vision of the state of clinical tri- als and how they can be improved? Given the specialized skills and intercompany I

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