Set Your Trial Up for Success—Select Your CRO and Decentralized Vendors in Parallel
“Set Your Trial Up for Success—Select Your CRO and Decentralized Vendors in Parallel” by Stephanie Eid was originally published in PM360. Click here to read the original article.
Selecting the right Contract Research Organization (CRO) for your clinical trial is a common concern and an essential part of the trial start-up process. Considering decentralized and hybrid trials are becoming more normalized, we are now seeing the need for sponsors to be more in the driver’s seat by selecting their technology vendors in parallel to understand compatibility, to ensure the operational success of their trial, and to reduce unnecessary costs and risk.
This means that the traditional role of the CRO has now shifted and evolved into a digital partner, so it’s critical to identify a CRO partner that also has the agility of a technology-enabled approach that leverages their capabilities to meet the demands of modern clinical trials, which are growing more creative and complex.
Navigating the Complexities of The CRO Selection Process
Outsourcing clinical trials to CROs continues to be a common practice as it allows sponsors to contain operational and infrastructure costs, while also gaining access to clinical trial and (sometimes) therapeutic expertise. But it takes an effective strategic approach to select the right CRO to set any trial up for success, as the CRO must be a true partner to the sponsor every step of the way. That partnership is critical because the success of a clinical study is largely dependent on how all the operations and execution are managed.
The entire CRO selection process can range anywhere from 8-12 weeks, depending on number of candidate CROs identified and responsiveness of the CROs to address queries and accommodate a potential bid defense meeting. A CRO may be contracted by sponsors as a full-service CRO to manage a whole host of components ranging from project management, data management, monitoring, regulatory, etc. or could be contracted for just a particular service.
The main role of the CRO is to plan, coordinate, execute, and supervise the processes involved in the development of a clinical trial, acting as a central contact point between the sponsor and other trial players (e.g., ethics committees, sites, regulatory agencies, vendors, and hospitals). All of these operations must be performed in strict accordance with Good Clinical Practice and CRO Standard Operating Procedures.
Though effectively navigating the CRO selection process is a common concern for sponsors, simultaneously evaluating and selecting decentralized trial (DCTs) vendors for the same trial is a new dynamic for our industry—and a process that will only increase as modern trials with an array of virtual tactics and components are more normalized.
Factors that play into CRO selection when trying to find the best partner for your DCT include:
1. Identify the right selection committee:
a. This team will coordinate the entire process in selecting which CRO will be qualified to perform the best outsourcing strategy.
2. Define your selection criteria:
a. This will be done by defining the needs of your project or program.
b. For example, are you looking for specific therapeutic area and indication or phase experience? Are you looking for a large CRO or a small niche CRO? Do you need international presence? What technology is being used for televisits, remote eConsent, eCOA, remote monitoring, wearables, and virtual sites? Defining your selection criteria early on is important to ensure you make the best decision.
3. Outline your bid defense considerations:
a. A bid defense meeting is an important step in the vendor selection process—it’s when each finalist is invited to an in-person or virtual meetings in which the CRO explains their proposal and answers questions to make sure both parties fully understand the assumptions and expectations for the study.
b. A best practice once bid defense meetings take place is to have a consistent process for evaluating the CROs which can be done via a scorecard. The scorecard provides the evaluation criteria or measures that are associated with standards for the sponsor Some are assigned quantitative values to subjective qualities as a way to rank. Sponsors should carefully assess the particular needs of their projects and look for the CRO that best meets their technical requirements and budget.
Why Decentralized Trial Vendor Selection in Parallel is Essential
Traditionally, a sponsor selects a CRO, and part of that selection process is to discuss any additional technologies and tactics that meet the needs of the clinical trial. Many times, CROs offer either an internal or an external partner solution. And in the past, some sponsors saw the technology vendor process as part of the CRO’s responsibilities and preferred to keep all clinical-related vendors under one central CRO.
However, in the decentralized-focused and technologically advanced clinical trials that are now more prevalent, more active sponsors have seen the benefit of leading this effort from within and not depending on the CRO to make those vendor decisions. Benefits to this parallel selection process, include:
- Financial savings:
- The CRO commonly adds a premium or up-charge to select and manage your technology vendors.
- Total trial control:
- The sponsor is in control of the technologies selected and the tactics for implementation.
- Accomplishes the oversight needed for the sponsor to effectively show regulatory authorities who they are partnering with on their trial.
We have seen complications arise when these selections aren’t conducted in parallel, for example:
- A CRO chose their preferred DCT vendor, which resulted in the sponsor not getting the needed technologies they required and found adjusting to a solution was challenging and seemingly impossible.
- Because the CRO had their preferred DCT vendors, and vendors are competitive with competing solutions, there wasn’t much room for a CRO to evaluate new options, resulting in limited options for the sponsor.
- The sponsor found the interpersonal dynamics with the CRO’s chosen vendors challenging as the attitude and working style wasn’t a match, resulting in poorly managed projects and challenging internal dynamics.
In summary, we’ve seen the value in separating these selection processes. In addition to saving time and exuding more trial control, it also allows the sponsor to check assumptions, qualities, and promises made by the vendor. Ultimately, driving all selection decisions allows the sponsor to be the decision maker on how the trial is executed and to prevent surprises along the way. But keep in mind to hold all selection candidates confidential if the selection process happens in parallel.
Our rationale for parallel selection of the CRO and vendors is that it positions the sponsor to pick the best match of vendors to ensure a successful trial. The match is key here. Considerations for a match include techniques and expertise needed for a particular trial, as well as ensuring the two vendors can work together and have complimentary solutions. If the sponsor allows the CRO to make this decision, they may not realize that the CRO is making the best decision for them and not necessarily for the sponsor.