3 Missing CRO Selection Criteria
December 16th, 2015
Why It’s so hard For a ClinOps Leader to Select the Right CRO
A mid-size biotech company was ready to start a phase 3 program in chronic kidney disease. Their phase 2 studies had been under the care of a well-known CRO, but they wanted to avoid doing too much work with a single service provider. They decided to competitively bid the project among their existing CRO and 2 other firms with global capabilities. The scope was “full service” and included ancillary services such as IXRS, Central Lab, central review of the primary endpoint and patient recruitment services.
The VP of Clinical Operations faced the challenging next step of choosing the right CRO. Despite the abundance of literature attempting to quantify and analyze outsourcing practices, the reality is that selecting a CRO is often a very subjective process.
The leaders at this biotech company historically categorized the following criteria for CRO selection:
- Experience in the desired therapeutic area or indication
- Assigned team members
- Infrastructure, processes and systems
- Access to sites and patients
- Value (not just the budget, but service you get for the price)
However, the historic selection criteria was insufficient. They needed a CRO that would provide them full transparency, a collaborative partnership, and real time responsiveness.
The 3 Most Commonly Overlooked Selection Criteria
The expectation that Sponsors oversee their CROs continues to put pressure on Clinical Operations leaders, as proven by many recent regulatory inspections and statistics issued by the FDA and MHRA. ClinOps leaders assume that they will have full visibility on study progress and milestones; however, this is something that needs to be actively pursued. Transparency has to be high on selection criteria list, so Sponsors can provide adequate oversight without needing to add resources.
In this case study, the Sponsor asked the CRO to provide access to all their clinical systems. This was a condition to work with them. Once they had an agreement, they used a data analytics partner to set up real-time dashboards that provided views of operational and patient data. They were empowered to keep their finger on the pulse of the studies. The full transparency is especially valuable for Sponsors who use multiple CROs and need insights across multiple systems.
Multi-data source visualizations provide Sponsors with predicted outcomes based on historic facts
Having full transparency on data and operational systems, such as the CTMS and EDC, allowed the Sponsor team to track important Study Quality Metrics and perform centralized monitoring with minimal resources. The sponsor was able to reduce their travel dedicated to co-monitoring by 50%. Upper Management was receiving regular executive summaries and this helped justify additional resources and budget allocation. When changes to the budget were made, a positive impact was seen in the first month.
Highly collaborative partnership
Another selection criteria that is often overlooked is the ability for the CRO to work in a true partnership. It is not easy to assess this characteristic. Partnership means many different things to different people and one needs to determine if the partners they are evaluating will carry out functions of the study the way they would manage it on their own.
During the bid defense meeting, this Sponsor decided to challenge the team and asked for examples of difficult situations and how they were able to resolve this as a fully integrated team. They assessed the level of ownership and accountability of the CRO team leaders. Once they observed that some of the key team members had a sense of ownership around the study and proved through examples that they shared the same goals as the Sponsor team, it made the CRO a clear winner to the selection team.
CROs and Sponsors need a single- view of analytics and ability to collaborate through data-driven tasks and workflows
The sense of accountability was seen every day. For example, the enrollment strategy was designed collaboratively and allowed the integrated team to reach their milestone faster.
Nobody ever said “this is not my job” or “sorry this is out of scope”. The CRO team felt empowered to own this program and took pride in setting up an aggressive timeline.
We all know that quick turnaround time and collaboration efficiency on addressing issues is critical. ClinOps leaders may evaluate CROs on their technical skills, and miss this critical business skill. Decisions need to be made confidently in real-time, so they do not put sponsors at risk of missing milestones.
This sponsor believed that the most successful CROs are the ones who track Study Quality Metrics in real-time, anticipating problems and resolving them before they become a risk to timelines and budgets. A few weeks delay in decision making can lead to very expensive outcomes, such as protocol amendments, multiple deviations and even having to enroll additional patients or repeat a study. The ability to make quick decisions based on current operational and patient data is a quality that should be evaluated in order to reach the full potential of a Sponsor/CRO relationship.
Email alerts and in-app notifications empower Sponsors and CROs to make quick decisions and mitigate risks
Responsiveness was a strength demonstrated throughout the project. The members of the fully-integrated team, both on the CRO and the Sponsor side, had access to data in real-time and could quickly adapt to the unexpected events that often occur in the course of a study. For example, the team was able to react to a high patient screen failure rate and a poor protocol compliance at top enrolling sites.
This biotech company followed a rigorous and disciplined approach for evaluating the intangible factors for CRO selection and eventually awarded the phase 3 program to a new CRO partner that exhibited transparency, collaboration and real-time responsiveness. The study start-up was done in record time, with the average site being activated less than 90 days from initial approval of the protocol.
We commend the innovative CROs who have proven true partnership and flexibility. They share access to their clinical systems to allow the sponsor to build real-time dashboards with consolidated data from multiple sources. They demonstrate ownership and collaborate. They show adaptability in making real-time adjustments when needed. They make it simple to perform adequate study oversight and documentation. These CROs quickly become the “heroes” of collaborative drug development: These are the CRO partners that enable their sponsors to achieve quality clinical studies at the maximum speed of execution.