Achieving CRO Oversight

With the state of CRO oversight processes today, many sponsors need answers: “Are my CROs doing what I hired them to do?” “Are they adhering to the quality plan?” “Is their performance meeting our expectations?” “What issues should we be escalating?”

With ICH E6 (R2), it is incumbent on the sponsor to oversee and manage compliance for all clinical trial activities, regardless of in-house or through a CRO. Sponsors now need to evaluate the CRO’s technology and approach to adhere to regulations such as ICH and the sponsor’s contractual quality agreement.

To measure the current state of CRO oversight, Comprehend Systems undertook a benchmark survey across more than 100 clinical leaders from global life sciences companies. The majority of respondents were clinops managers or executives, and most were involved in multiple trials, some as many as nine.

The survey assessed gaps and needs, providing insight into how and where sponsors and CROs can improve their collaboration and processes. Key findings included:

• CRO oversight is a top priority due to pending ICH E6 updates and increased use of CROs

• Gaps exist in the core CRO oversight execution processes

• Spreadsheets and reactive management are not sufficient for proactive CRO oversight

CRO oversight priorities

A striking observation was that although CRO oversight is a top priority, only 34% of clinops leaders indicated that they had successfully achieved their planned CRO goals. When asked if they had confidence in being able to achieve their CRO goals, only 22% of respondents responded positively. This points out a significant gap in sponsors’ capabilities and highlights the monumental effort required to close that gap.

Respondents ranked the reasons why CRO oversight is a priority for them. Their #1 reason, not surprisingly, was to avoid trial delays. But the ability to oversee the CRO work product, mitigate risk and meet compliance requirements were also key. When asked about their relationships with their CROs, less than 20% of respondents believed their relationships were productive, and more than 85% felt they were not efficient at CRO oversight.

Data quality and uncertainty

As the use of CROs increases, so does the amount of sources and data created to navigate and understand key study questions. Sponsors are inundated with CRO information in order to keep studies on track. In addition, much of the information is received in notes or spreadsheets, where manual entry lends itself to a high error rate. If available electronically, much of the data needs to be converted from one system (or format) to another, requiring data management skills and processing time -over and above daily tasks for clinical operations teams. Much of that time is spent cleaning up common errors and omissions. When sponsors want to oversee site performance, they need to be able to quickly understand queries and resolution rates, requiring a high level of data accuracy.

71% of respondents claimed “data transparency and real-time access to quality data” were the top priorities for a successful CRO relationship. In fact, 83% claimed the need to automate CRO oversight, including real-time data aggregation across systems, was “critically significant to success.”

Core processes required for CRO oversight that were deemed highly important but unsuccessful focused around subject, enrollment and site performance as well as executive and budget visibility across studies and portfolios. 75% claimed enrollment issues were the most common cause of a milestone delay from FPI to LPO. Sponsors clearly do not have the KPIs available to help them manage issues such as enrollment leakage, missing data per visit, or successful query resolutions. Systems in use today are causing a lack of data accessibility and timely harmonization. As well, critical KPIs need to be aligned with these core processes and be ready-built for use, rather than becoming another time-consuming task for IT or data managers to custom create.

An underperforming CRO can suffer trial delays by more than 6 months, increased workload and cost overruns due to excessive change orders. In fact, 78% of respondents claimed that their three-month CRO change orders exceeded $100K, and more than half claimed the orders exceeded $200K. However, with CRO responsibility evenly shared among study managers, CRAs, data managers and ClinOps executives, it is apparent that standardization of CRO oversight processes is required.

Best practices and automation

Some interesting insights from this survey have emerged such as the need for standardization of processes, data management and methods. Following are the five critical elements to achieve process standardization in CRO Oversight Plans:

• The adoption of appropriate KPIs

• The use of KPI thresholds

• A process to monitor the KPIs

• An issue management process

• An escalation process

When asked which KPIs were top priority for oversight, executives and practitioners each ranked them differently, making it difficult to standardize metrics per CRO, but point out the need for end-to-end data transparency:

Automation that aggregates multiple source data files and feeds prebuilt KPIs in real-time speeds processes and insights, top provide immediate visibility and reporting that eliminates manual handling and error-checking. Automation should fully support GCP guidelines including complete audit trails and documentation for any inspection or regulatory requirement.

As business grows with the addition of more CROs, these insights will help you address key challenges and regulations more quickly and effectively. Maximum preparedness can be achieved through current best practices coupled with automation to achieve your CRO oversight and milestone timelines.

Julie Peacock, Strategy at Comprehend Systems