As CROs Merge, How Should You Assess And Manage Your Partners?

By Ed Miseta, Chief Editor, Clinical Leader

Consolidation in the life sciences industry is a fact of life. The recent merger of Quintiles and IMS Health is just the latest in a string of consolidations. Research firm ISR Reports anticipates the merger activity will continue, with large CROs adding companies with complementary services and midsized CROs attempting to quickly gain scale.

While this activity may be good for the companies involved, it can be a time of angst for sponsors. Changes to policies and procedures, trial disruptions, and uncertainty over who might be running studies are all legitimate concerns. For some sponsors, it might also be a good time to reevaluate existing CRO relationships. But what is the best way to manage CROs and evaluate their performance?

There are certainly several categories in which partners should be rated, and each category can contain numerous issues, both qualitative and quantitative, that must be evaluated. Market research firm Clinical SCORE recently conducted extensive interviews with principal investigators and study coordinators. Their concerns were noted and validated through over 1,000 interviews. Additional surveys were then conducted that encompassed over 400 trials to investigate how the categories and issues related to successful and unsuccessful trials.

“We used this normative database as a means to determine the priorities that sponsor trial managers should focus on to ensure successful trials,” says Ross Weaver, managing director for Clinical SCORE. “Those priorities can also be used by upper-level management at sponsor companies to perform oversight of their CROs.”

Challenges With Sites And CROs

 Every trial comes with its share of challenges. While some are particular to a specific study, many are common to all trials. With every study, for example, sponsors are competing with other trials for the time and resources of sites. Research has shown that on any given day, study coordinators are responsible for a minimum of five trials, perhaps more depending on the therapeutic area. Generally it’s the squeaky wheel that gets the oil. But in clinical trials, the squeaky wheel can get ignored. That can make it difficult for sponsors to make their voices heard.   

CROs also cater to many sponsors simultaneously and have to deal with the same constraints on the time and schedules of employees. “Sponsors don’t often know the specifics as to who the exact CRO representative may be for each clinical trial site, how often they change, and how many sites each CRA/Monitor has responsibility for,” says Weaver.

Moe Alsumidaie, chief data scientist for Annex Clinical, agrees. He notes it is common for CROs to allocate CRAs to numerous trials in order to attain scalability in clinical operations. For most CROs, successful operations are generally based on balancing quality with scalability.

“This model usually works quite well, in my experience,” he says. “However, this model has also fostered unforeseen outcomes that can adversely impact study operations. For example, CRAs allocated to specific studies may not have the therapeutic expertise and medical training required to identify issues with compliance and data quality, such as detecting adverse events by monitoring medical records.  Moreover, CRA turnover is a common phenomenon with CROs. This significantly impacts the relationship with sites, which subsequently, affects site staff motivation and study timelines.”

Challenges Can Be Difficult To Measure

Weaver notes a big challenge to sponsors when evaluating sites and CROs is that some of the primary issues that arise in outsourcing relationships are also difficult to measure. Issues such as timeliness, quality, and productivity are very broad. This forces sponsors to come up with more specific categories and issues that transcend and impact each of the broader categories.

One evaluation system, created by Clinical SCORE, allows primary investigators and study coordinators to easily rate the overall categories. If there is an area where a problem exists, they can select those issues that are creating the problem. A normative database can point out where problems exist and, in so doing, help sponsors determine specifically what needs to be done. A tracking mechanism can be used to determine if the sponsor’s actions have succeeded.

Challenges that exist for sponsors are made all the more difficult when a CRO is hired, creating another level of management (and complexity) between the sponsor and the site. “Incorporating a CRO into a clinical trial can create distance in the relationship between the sites and sponsor, which impacts study performance,” notes Alsumidaie. “Sponsors have focused a lot of effort on mitigating regulatory and operational risks in CRO oversight by establishing robust SOP infrastructures and comprehensive CRO feasibility procedures. However, sponsors have not yet established systems to measure study performance from the site's perspective. For example, how is the relationship between the site and the CRA impacting study timelines? Does the site have sufficient capital to properly execute the study, or did they underestimate resources during budget negotiations? Establishing a technological measurement system that enables the sponsor to listen to and analytically quantify site perspectives can unveil a lot of critical operational factors directly from the ground. And, sponsors can enhance not only CRO oversight, but also study oversight by uncovering and addressing on-the-ground issues.”

Look At The Site’s Perspective

Alsumidaie believes evaluating CRO performance from the site's standpoint enables the sponsor to access quantifiable metrics they can use to evaluate CRO performance. The beauty of an analytical approach is that sponsors can evaluate sites on operational factors, such as enrollment and data quality.

“There will always be unforeseen circumstances impacting study operations, and successful project management requires rapidly identifying and addressing issues as they come along,” he says. “Utilizing a technology system and rigorous research process to uncover performance issues from the site will enable sponsors to rapidly identify issues and collaboratively address the issues with their CRO.”

Weaver agrees and points out there are several things that sponsors should consider doing differently when it comes to site and CRO assessments. First, identify in real-time the problems that exist with clinical trials. These problems should be identified across therapeutic area, across region of world, and across CROs. If common problems exist for the same CRO, those issues should also be identified across therapeutic area and/or region of the world. There may also be other commonalities of trials that can be assessed, such as the age of patients.

“This level of measurement will also enhance communication between sponsors and CROs, which will undoubtedly assist both organizations in streamlining the clinical trial operation,” says Weaver. “This is an issue that will create struggles for all sponsor companies, regardless of size. But getting a handle on these challenges will be necessary for sponsors, CROs, and sites to all collectively improve the quality of trials and expedite the cost and timeliness of trials, which continue to plague the industry.”