10 Tips for Enabling Better CRO-Sponsor Collaborations
By Craig Morgan, brand development director at goBalto Inc.
By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.
The reality is that the sponsor-CRO relationship is not always a win-win. While sponsors are clearly enticed by the efficiencies that can be gained through CRO use there is nonetheless a downside to the relationship. The fact is that a sponsor must entrust the study performance to a third party, and that same performance is ultimately the measure upon which the sponsor’s development organization is judged by its senior management. To date, sponsor and CRO interactions have been fraught with inefficiencies and needless duplication of task ownership. This lack of trust and inability to empower the partnerships leads to confusion and frustration for both parties. In addition, the need for multiple partnerships for both the Sponsor and CRO bring with it the complexity of different goals, processes, and culture. A sponsor’s need for multiple partners to manage large pipelines (or the need for specific therapeutic experience) inevitably results in a complex operating environment with multiple moving parts. With differing business models and financial incentive goals the partnerships need a clear plan for success.
To a great extent, the future success of the life science industry in bringing new products to market rests on the ability of sponsors and CROs to work together successfully, providing both parties a compelling incentive to strengthen their partnership with the help of the right structure, tools, and strategies.
Ten Tips for Successful Collaborations
- Take the time to learn each other’s “language” and culture with mutual due diligence
For major collaborations, sponsor study teams need to invest in learning the ways of working at the CRO.
- Establish a mutually agreed and practical communication plan with escalation parameters at all levels of the team (Executive, Management and Operations)
What event(s) trigger an escalation? What information is generally expected to be communicated throughout the course of the study and by whom?
- Develop and maintain study/site risk assessment plan: Ensure agreed risk mitigation actions in advance where possible
Performing on-going risk assessments at both the study and site level is a critical activity that drives quality of the data and ultimately successful study outcomes.
- Define business processes, including roles & responsibilities (these may go beyond the transfer of obligations agreement)
Make sure everyone on the team understands the overall process associated with key study activities and where they play a part.
- Establish Key Performance Indicators (KPIs) for partners and study deliverables
To be meaningful and effective, members must understand how the study progress is being measured and why.
- Agree on level of transparency and accessibility needed to ensure lagging KPIs and risk indicators are recognized in advance
What is the team going to do if there is a problem? Who is responsible and what communication channels are used? See 2 above.
- Establish common team goals to be aligned with partner business goals where possible
- Invest in software tools that enable communication, management, and automation of activities
Cloud-based platforms that enable immediate data sharing across partners are ideal for this purpose.
- Develop incentives to motivate team members to support short term study and long term partnership expectations
Treat study team members as “one.” Allow CRO partners to have a say in things like protocol design, monitoring plan, and data management practices.
- Create an atmosphere of positive collaboration
At its core, collaboration requires two-way communication and transparency. Mechanisms should be put in place to enable two-way communication and feedback between CROs and sponsors – promoting a culture of continuous improvement.
These practices are the first step in the journey to move from a tactical client/vendor relationship to a more strategic operating model, where teams operate on a united front with shared goals and aligned structures and processes. This translates to increased resource productivity, cost savings, and ultimately, more successful studies.
 Research and Markets: The New 2015 Trends of Global Clinical Development Outsourcing Market, January 20, 2015 http://www.businesswire.com/news/home/20150130005621/en/Research-Markets-2015-Trends-Global-Clinical-Development#.Vh50c-xVhHx
Craig Morgan is a technology and life sciences management professional with more than 15 years experience in the application of informatics and bioinformatics to drug discovery. He currently heads up the marketing and brand development functions at goBalto, working with sponsors, CROs and sites to reduce cycle times and improve collaboration and oversight in clinical trials.