Our recent survey of more than 100 global Contract Research Organizations (CROs) uncovered a number of revelations – some surprising, and some reflecting further validation of a market that is growing but with its challenges.
Over the past number of years, outsourcing various aspects of clinical trials has become a steady and ongoing practice for pharmaceutical organizations. In most cases, outsourcing activities such as site management, subject recruitment and data management has provided relief for pharmaceuticals whose time and efforts can be focused on treatments, drug design and delivery. However, the trade-off results in some serious considerations for both Sponsor and CRO in terms of study project management, cost and compliance.
The CRO market remains strong, as indicated by positive analyst ratings and the busy consolidation activity seen over the past year or two. One analyst firm called out the 2016 market at $74B, and estimates that the market will continue to grow about 5% from large pharmaceuticals and by about 9% from small-to-midmarket pharmas. In the survey, CROs confirmed some of the reasons for the growth pattern. 100% of survey respondents were involved in study project management (typically Phase II/III), and nearly 70% conduct 25 or more studies per year, involving 15 or more sponsors. As these CROs take on more business, they confirmed that they are developing a full-service model for their Sponsors, expanding into all operational areas but with a particular focus on managing data.
The effort of managing data is causing a couple of significant ripples. One, if CROs are using disparate systems to maintain operational trial data, integration and harmonization lag time can cause milestone delays and, potentially, safety risk issues. Two, if CRO teams depend on antiquated methods such as spreadsheet reconciliation of subject and site data, the process will not scale to support growth. 67% of respondents told us that while they use CTMS and/or EDC systems for their clinical data management, they are unable to draw real-time analyses from these systems—hindering timeline decisions and goals for expansion.
With ICH E6 (R2) calling for Sponsor responsibility over CRO risk and work, CROs are becoming more attentive to the demands of Sponsors and how to address them. 100% of CRO respondents claimed that Sponsors’ evolving priorities was their top challenge in the relationship. Changing priorities are likely a reflection of activity from adaptive trials, increasing data complexities and issues surrounding risk and compliance. In most cases, these issues can be addressed in Quality Agreements and Vendor Oversight Plans, agreed upon between Sponsor and CRO in advance of study startup.
When asked about the process of sharing data with their Sponsors, CROs had some interesting responses. CROs unanimously claimed that addressing real-time analysis to support milestones was a top consideration. However, only 18% of them actually share analytics daily or in real-time with their Sponsors. Instead, they produce reports on a static schedule, updating reports as their various transactional systems update. When information lags to the Sponsor, it’s not hard to understand how Sponsors are causing the “evolving priorities” that plague CROs.
CROs called out a number of areas where improvement could be made in the Sponsor-CRO relationship. More than 90% claimed underestimating study duration and resources as key.
“What are the underlying barriers to a successful relationship?”
A Roadmap to Success
The three key findings in the Survey report call out where CROs can focus to improve their relationships with Sponsors, decrease complexity and scale to grow their business.
- Reduce gaps in operational processes
Eliminate the data integration lag time and employ real-time data access and reporting for Sponsors.
- Improve your code of responsibility with Sponsors
Be willing to jointly work from Quality Agreements and Oversight Plans to reduce conflicts, empower better work plans and establish metrics you can both live with.
- Automate wherever you can
Reduce cycle time, increase accuracy, improve compliance and enable scalability. This alone will provide tremendous returns for the amount spent.
For more information about the survey, download your free copy of our Infographic on the CRO Benchmark Survey, or contact us at firstname.lastname@example.org.
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