Of all the big decisions to be made when conducting a clinical trial, perhaps the biggest of them all is selecting the right CRO for the job. With all the moving parts inherent in a trial, it is critical to find the right partner, and one that can deliver results in a timely and cost-effective manner. But what criteria should a sponsor look at when selecting a CRO? Here we outline some of the major factors you should weigh when making this decision.
Cost – Perhaps this is an obvious statement, but naturally cost will be a determining factor for most sponsors looking to run a clinical trial. It is important to select a partner that can perform your trial within budget. Unfortunately, regardless of how much you like a CRO, if the cost is too high it can be a deal-breaker. This is a delicate balancing act however, because while it may be tempting to go with the lowest bid for the project, you need to stop and consider and a few things:
- Are the quotes you’re receiving ‘apples to apples’?
- All the line items need to be comparable, otherwise you may run into a situation where one CRO appears lower on paper, but in actuality is not lower in cost.
One other approach to manage cost in clinical trials is through getting the CRO to bid based on your template, i.e. ‘bid grid’.
Depending on whether you prefer a fixed fee type of arrangement or a pass-through arrangement, you have many options when finalizing cost with your CRO.
Finally, one other solution to help keep trial costs under control is through a discount for a group of trials. Perhaps you have a group or series of trials on the table. If you feel confident you have found the right CRO to partner with, you can often get a discount across the board for awarding the package of trials to that CRO.
Timelines – We all know meeting timelines is of paramount importance to the success of a critical trial. Every CRO is going to promise that they will deliver on your aggressive timelines. But how can you be sure this is true? When evaluating CROs for their ability to deliver on-time results, look for a prior track record of proven success in meeting milestones. Your partner should be one that has consistently performed on time or ahead of schedule.
Another way you can help ensure the CRO you are partnering with will meet timelines is to have certain assurances and even incentives built into the contract. There can be a monetary bonus at stake to help motivate the CRO to deliver results ahead of time. On the flip side of the coin, if milestones are missed, it could lead to a penalty to be paid back to the sponsor. Thus, by clearly setting expectations ahead of time, both parties will be held accountable to delivering on those milestones.
Quality – It may go without saying, but quality of the data is critical to the overall success of the clinical trial. But how can a sponsor be sure that their CRO will deliver quality data? It is important to look into a proven track record of success. If the CRO you’re considering has a history of delivering successful results, this is usually a promising sign. Additionally, you can conduct a quality audit of your prospective partner. Do they have any past 483’s? Are there any red flags that you uncover? It is important to do your due diligence before entering into a partnership.
Finally, the therapeutic experience of a CRO can profoundly impact the quality of the program. If the CRO and its project personal have worked on that indication before, that expertise will benefit the overall execution and quality of the trial.
Communication – Moving beyond the more obvious criteria, communication is a very important factor when selecting the right CRO. While larger CROs offer benefit in their vast experience, the potential downside is infrequent communication. Project managers at larger CROs are often managing many huge studies and don’t have the time to provide frequent communication to all their sponsors. On the opposite end of the spectrum, smaller CROs will likely provide you with a project manager who is very dedicated and committed to your project. In addition to frequency of communication, the style of communication is another important consideration. When evaluating CROs, make sure you know which project team members will be running your project and that you feel comfortable working with those individuals. There are always going to be some roadblocks that arise during the course of the trial, but as long as you feel you have a partner you can communicate with effectively, then those hurdles can be overcome.
Strategic Thinking – Finally, when choosing your CRO, don’t underestimate the power of a partner who can think strategically. While it is easy to send out the specs of a project and receive a series of bids in return, not all projects are straightforward. Depending on the indication or type of clinical trial at stake, there are more often than not many intricacies that need to be taken into account. The good CROs will separate themselves from the pack by recognizing those nuances and offering suggestions or creative ideas to potentially approach the trial in a different manner. From their experience in this therapeutic area, they may know a way to improve oversight, mitigate risks, or design the trial differently to factor in important variables. Ultimately a discussion can take place and both parties can decide the best way to run the trial, but a CRO that demonstrates the ability to think outside the box is a valuable partner.
Catawba Research, LLC is your perfect CRO partner:
- Cost. We are constantly striving for process improvement. The resulting improved efficiencies and productivity have greatly benefitted our clients in cost savings. We are very proud to state that Catawba Research has not requested a single change order due to our miscalculation in the scope of work. Request a proposal on your upcoming trial from us.
- Timelines. Time is money. Catawba Research is acutely aware that our clients are financially impacted when every day a project is delayed. We have been on time and/or ahead of time for every clinical trial awarded to Catawba Research.
- Quality. Catawba Research has undergone numerous successful audits. The audits evaluated the Catawba Research facilities and services in compliance with US FDA regulations for clinical trials and generally recognized good clinical practice.Catawba is ‘not a jack of all trades’, we focus on what we know. Visit www.catawbaresearch.com/therapeutic-experience/ for our therapeutic experience. Moreover, Catawba Research contracts with vendors that have also successfully undergone similar audits by the FDA.
- Communication. Our project managers work on a limited number of trials in order to focus on (y)our trial to become YOUR advocate and partner. Our project managers will be dedicated and committed to your project. In turn our quality and style of communication is frequent and pertinent. Catawba Research’s philosophy is that we are an extension of your clinical development group.
- Strategic Thinking. Catawba Research carries out a ‘post mortem’ on every completed trial to understand the lessons learned from our latest campaign. This serves us well in planning for upcoming trials and provide valuable data for process improvements.
By using these five criteria, you can hopefully sift through the list of prospective partners and choose the right CRO for your upcoming clinical program. Catawba Research lives by these five pillars and is dedicated to providing excellence to our sponsors. To learn more about Catawba Research’s services or to request a quote on an upcoming project, reach out to us.