The relationship between a sponsor and a CRO is a critical aspect of an effective and timely clinical trial; when the relationship is transparent and smooth, the benefit is seen by all parties. Conversely, issues such as poor sponsor/CRO communication and a lack of defined responsibilities and pathways can result in delays, miscommunications, and, at worst, a failed trial.
To understand how sponsors and CROs can maximize the effectiveness of these collaborations, we asked for advice from Clinical Operations Team members of Alira Health, our parent company:
- Katrina Petrosino, Project Manager
- Jen Petrillo, Project Manager
- Peggy Healy, Project Manager
Q: What is the most important factor in a collaboration between a sponsor and CRO?
A: From our experience, the most important element of a successful collaboration is maintaining clear and frequent communication. This can come in the form of scheduled check-ins with the sponsor, a clear definition of project goals and timelines, and ad-hoc calls to discuss issues and their resolution. Communication is essential in cultivating a strong working relationship and gaining clients’ trust.
Q: How do you suggest managing communication between sponsor and CRO?
A: When the project begins, if possible, we try to schedule an in-person kickoff meeting to establish a face-to-face connection between team members. During COVID, this has become a bit more challenging, but fostering the connection with the client can still happen virtually.
It’s important to schedule regular teleconferences. Typically, we set up a weekly call with each client, but modify the schedule based on their preference. Between these calls, it’s important to make time to provide updates and answer client questions.
For each project, the Project Manager will create an official Project Management Plan and a Communication Plan with clearly defined escalation paths. These plans outline responsibilities for each party and define the process for escalation if needed. It is crucial to document any decisions or discussions via email for the Trial Master File, and it is also important to discuss complicated issues over the phone.
Q: How can you maximize the effectiveness of your partnership?
A: clearly define all roles and responsibilities so that all parties know who is doing what. This can be done during sponsor calls or formally documented in study plans such as the Project Management Plan or an official document like the Transfer of Obligations. We don’t want two organizations working on submitting to ClinicalTrials.gov while no one is submitting to the Central IRB.
Additionally, it’s effective to utilize everyone’s unique skill sets to the best of their abilities. For example, perhaps a client has a working relationship with a Key Opinion Leader who may be able to recruit lots of patients.
Finally, understand the client’s perspective. How can you help them meet milestones and timelines while also setting realistic goals and expectations? This is often a bit challenging but being able to communicate this openly is a great place to start.
Q: What are the best practices in setting up CRO oversight?
A: Ensure that projects are staffed with trained individuals with experience in a given study indication or type. This will set up the CRO team for success while ensuring the sponsor that the study is in good hands.
Set clear timelines and responsibilities. It might seem redundant, but when all parties are aligned on goals, and the timeline to achieve them, it helps to manage sponsor expectations.
Q: What are the key documents in sponsor CRO collaboration?
A: These are the vital documents to produce:
Project Management Plan
This outlines project scope, timelines, project team structure, risk, and contingency management, forecasts meetings, and describes the expectations for these meetings throughout the life of the study. It also outlines training expectations as well as study reports and metrics delivered to the sponsor throughout the study.
Transfer of Regulatory Obligations (TORO)
This is an official document that formally documents the responsibilities a sponsor has delegated to a CRO or other service provider throughout the study.
Risk Management Plan
This document describes risks specific to the project and how to mitigate them. Sometimes this is included in the Project Management Plan.
Trial Master File (TMF) Plan
This plan outlines the process for construction and maintenance of the Trial Master File and the process for ensuring a complete Trial Master File at study close-out.
This plan facilitates compliance with FDA regulations and the International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines. This plan outlines data to be monitored, the timing of visits to sites, practices for monitoring, and guidelines for reporting.
This outlines study team contacts and ensures communication and escalation pathways are defines.
This is often designed as a tracker which outlines the goals, milestones, and realistic timelines for achievement.
These are used to document study progress, track patients, track sites in recruitment. They also document start-up costs, budgets, and contracts.
Q: What is the standard that sponsors and CROs should follow when it comes to documentation in a clinical trial?
A: For each study, we document everything! All major decisions should be formally documented. Minor decisions can be documented in a less formal way, such as in meeting minutes or a Frequently Asked Questions tracker. It is also a good idea to keep a running action items tracker so that items do not fall through the cracks.
We recommend tracking every element of the clinical trial. This includes the status of contracts, budgets, and patient visit scheduling to name a few examples.
Q: How can you assess the success of your sponsor/CRO collaboration?
A: Following completion of a study, doing a retrospective analysis can help to answer the following questions:
- Were timelines met? If not, what could be done differently next time?
- Were problems that came up predictable or avoidable?
- Deviation count—were sites able to adhere to the protocol throughout the study?
- Query count (was EDC set up well and were there clear guidelines for entering data?)
- Time to reconcile the Trial Master File (was it well maintained through the study?)
Q: What are tips for ensuring that high-quality data is collected as part of the sponsor/CRO collaboration?
A: Here are some of our suggestions for ensuring that you get the best out of your collaboration in terms of data:
- Project Manager oversight of data management activities
- Proactive management of data can help prevent undesirable trends in site data entry and allow for creation of useful reports and listings throughout the project.
- Monitor oversight of sites
- Our method of site management is different than some CROs. Each site is assigned an In-House CRA and an onsite or traveling monitor. While the In-House CRA is available to answer site questions on a day-to-day basis, the traveling monitor performs source data verification. Traveling monitors alert the project management team of trends in data entry issues or regulatory issues that sites are having because they establish and maintain a face-to-face connection with sites.
- PM oversight of monitors
- Project managers oversee both the in-house team, and the traveling monitors for each site. Providing effective oversight reduces site issues and facilitates troubleshooting problems as they arise.
- eCRF Completion Guidelines
- Guidelines for completing forms in the data entry system are crucial to keeping data consistent across sites, as well as helping in lowering the number of queries and data discrepancies throughout the study.
- Study-specific trainings on the data entry system for sites and monitors.
- Often, a sponsor will only rely on system-specific trainings which are built into the EDC system or provided by an EDC vendor. Holding a study-specific training can help alleviate data entry issues on specific forms, which should result in data consistency and reduce the number of queries.
Would you like a personalized consultation on maximizing your CRO partnerships and bringing your clinical trials on a new level? Contact Christopher Rao, Vice President, Clinical Development.
About Alira Health
Since 2021, CROS NT is part of Alira Health, a leading patient-centric data and tech-enabled services provider.
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