Recently, a team of IMARC monitors traveled to a sponsor’s clinical research headquarters to meet face-to-face, study team to study team, to kick off a new medical device study. The two teams joined together with a heavy agenda to get the study’s ducks in a row prior to our monitors hitting the road for the on-site initiation visits scheduled in the upcoming weeks. While this is not always the case at study start-up, with tight timelines and limited budgets, there are many advantages to getting the teams together at the beginning of the study to help prepare for a successful study. Additionally, the teams can process through potential study challenges before they become potentially larger issues. Read on to learn five reasons why the sponsor should meet with and include the CRO in study start up!
- Training - Not only are face-to-face study start ups between the sponsor and CRO good for training the monitors on the protocol, EDC, and sponsor SOPs, but it is a great time to review the training materials that will be presented to the sites. Often, training modules and tools created by the sponsor have been in development for months and have been subject to several levels of review and quality assurance. The independent, fresh set of monitor eyes may help to identify areas of confusion in the interpretation of the protocol, inconsistencies in the EDC programs, or additional areas of training that could be beneficial for the sites. Just last week, while reviewing the slides for site training, the sponsor made a few updates as a result of the monitors’ feedback.
- Regulatory Review - At the beginning of a study, in preparation for site initiation visits, regulatory documents are flying between the site and sponsor. Sites are in different stages of the start-up process and project managers are pulled in several different directions to stay on timelines and with in budget. CRO involvement at the beginning of the study can allow for the regulatory document collection and review assistance. Allowing the CRO to be in loop for collecting medical license, CVs, laboratory certificates and normal ranges, and so on, can lessen the burden on the project manager and allow him/her to focus efforts on other areas of study start-up.
- Lessons learned - Chances are-CROs have helped other study teams get a study off the ground. Chances are even likelier that this isn’t the sponsor’s first study. Regardless of the study team’s experience, sponsor or CRO, coming together at the beginning of the study can allow for sharing of lessons learned from previous experience from both perspectives. The sponsor can share what has worked for previous studies, either with the current CRO or others that they have collaborated with in the past, as well as challenges and road blocks. The monitors can share valuable experience with study start up with trials that are in the same therapeutic areas or with familiar clinical research sites.
- Establishment of roles and responsibilities - A CRO operates as an extension of the sponsor, however, roles and responsibilities are not always clearly defined. An ideal time to establish roles and responsibilities is at the start of a study. If the CRO is involved from the beginning, a clear communication path can be paved and the teams can begin to work through a new relationship before the sites are introduced to the study team. This approach can unify the two teams and help them work more effectively with the sites as the study continues into enrollment and follow-up.
- Team building - You wouldn’t expect a high-performing sports team to hold Webex practices and then show up to the first game and win. Same is the case when building a team between the sponsor and CRO. Meeting face to face allows for valuable team building that is lost when study teams “meet” solely via teleconferences and Webex . Understanding that no matter what you are bringing to the clinical research field, from sponsor, CRO or site, the goal of the team is the same; patient protection and good data.
It may seem costly and delay the start up of a study by selecting and bringing the CRO into study start-up activities, however, there are many benefits that could effect the study success long term. Does your company tend to include the CRO in study start up? Are you from a CRO that has been involved in study start up or wishes that you were? Please share your thoughts here.
Photo Credit: Rosmary