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RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from the article “Integrated CRO alliances growing but poorly executed” by Karyn Korieth, which appears in The CenterWatch Monthly September 2011 issue.
Results from a new CenterWatch survey show CROs believe that while the prevalence of integrated alliances with sponsors will grow in the next three to five years, many sponsors fall short when managing these more sophisticated relationships.
In the survey, the first to measure how well sponsors are handling these newer forms of outsourcing, CROs generally gave those companies with more strategic, integrated relationships higher “good/excellent” ratings than those in traditional transactional and functional service provider (FSP) relationships. Yet CROs said sponsors are not meeting their expectations in several important areas, including clearly outlining roles and responsibilities, maintaining open communications and creating collaborative team environments.
While many sponsors want to form integrated alliances, which can offer better performance and efficiency along with cost reductions, many are struggling with how to manage them and leverage the benefits CROs can offer. The survey suggests a gap by sponsors between adopting these outsourcing strategies and implementing them at the team level. Sponsors must not only establish the in-house mechanisms to succeed, but also focus on strategy execution and prepare teams for moving into these new types of relationships.
“To be successful, partnerships must have well-developed governance constructs, open collaboration, a deep level of information exchange and an outcomes-based approach, focused on sharing risks and rewards,” said Josef von Rickenbach, chairman and CEO of Parexel International.
Until now, sponsors’ success in managing these newer alliances had never been formally measured.
The survey, conducted online between March and June, measured the success of CRO-sponsor relationships, focusing on how CROs rate sponsors in transactional, FSP and integrated alliance relationships.
The results were based on responses from 134 CRO project managers, directors and associate directors with an average of 14 years of clinical research experience. Nearly 70% were employed by large CROs; one-third were from the U.S., followed by the Netherlands, Canada, France and Hungary.
CRO professionals evaluated 52 sponsors, with the majority top biopharmaceutical companies, rating sponsors they had worked with during the past three years on a range of relationship attributes—including the work award process, personnel and work-style issues, general trial management, project oversight and financial issues—and rating their importance.
Gaps identified
In integrated alliances, the parties must be able to work autonomously and communication must be fluid. The survey found CROs generally see alliance relationships as the most successful model for effective collaboration; CROs gave alliance sponsors higher “good/excellent” ratings than those in transactional relationships in five out of seven categories, including the work-awarded process and project initiation activities. Sponsors in alliance and FSP relationships also received fewer “fair/poor” ratings for personnel and work-style issues (7%) than transactional relationships (18%); in program management, only 17% of sponsors in FSP and alliance relationships received “fair/poor” ratings compared to 32% in transactional relationships.
Significantly, the FSP and integrated relationships received a higher “fair/poor” rating (11%) than those in transactional relationships (5%) in the oversight project category, which includes clearly defining governance team roles and establishing an efficient issue resolution process.
The survey also identified significant gaps between attributes CROs rated most important and the performance of sponsors in integrated alliances. 72% of CROs rated having clearly defined roles and responsibilities as “very important,” yet only 18% rated the average sponsor in integrated alliances as “excellent” in this area. Similarly, 68% identified maintaining open communications as a top concern, but only 30% rated sponsors with integrated alliances as “excellent.”
There was a 26% gap between importance and performance in creating a collaborative team environment. Significantly, 63% of CROs said having expectations clearly defined in documents was “very important,” yet only 8% gave sponsors in integrated alliances high marks.
CROs also suggested the ability to work autonomously is important for an effective collaboration. More than 70% said it was more efficient to allow CROs to use their own SOPs after sponsor review, and more than half found it ineffective to use the sponsor’s performance metrics.
Establishing strong alliances
If sponsors seek to gain greater efficiency and more effective collaboration from integrated alliances, they need to improve partnership skills, including establishing more open communication and creating collaborative environments.
At Eli Lilly, which was among the first sponsors to form long-term strategic alliances and received among the highest marks from CROs, there are three levels of governance for strategic partnerships: executive, operational and team.
Clearly defining roles, responsibilities and core competencies also helps sponsors and CROs learn how they can work as a team and take full advantage of the expertise each partner brings to the table. Another important element for a successful alliance is working with partners to establish a robust quality management system.
The gap between CRO expectations and sponsor performance in key relationship attributes suggests execution of the new approach often falls short.
Many companies face a challenge, from an operational team perspective, in getting everyone on the same page and working consistently with their alliance partners. Implementation of the strategy breaks down when sponsors fail to create mechanisms and structures that will engage everyone involved. Local teams often are not given the tools and support needed to be successful and sometimes are left to figure out how to make an alliance work on their own. Some sponsors have begun experimenting with a cross-functional role called a relationship manager, an internal function with the task of making sure all of the disparate team members understand and comply with the new strategy.
Early measures of the impact from Pfizer and Eli Lilly, which were among the first sponsors to pursue aggressive alliance strategies, show their alliances have resulted in significant cost savings, cycle time improvements and fewer contract delays. Eli Lilly has reported 20% cost savings on data management and monitoring FSP relationships, while Pfizer has saved $20 million by consolidating its vendors from 150 to 17. Pfizer has improved enrollment cycle time by 26%; Eli Lilly reports a 93% improvement in monthly patient enrollment volume. Pfizer’s alliance strategies have resulted in an 80% reduction in the number of contracts delayed by more than 120 days.
From the site perspective, how are these new integrated alliances faring, and are they having a positive or negative effect on site operations?