It’s pretty common for a pharmaceutical company to have a list of demands ready when choosing a CRO partner for a clinical trial. Here at Biorasi, we have some demands of our own that we consider non-negotiable and vital to the success of any trial. This isn’t because we’re divas that come with a rider. It’s because without some key commitments from the sponsor, study success is far from guaranteed. These non-negotiables help to ensure that sponsor and CRO move in concert to achieve a clear and well-defined goal – moving your clinical development program in the right direction.
- Be available for both planned and unplanned communication.
Because communication between sponsor and CRO is so important, we develop an entire communication plan prior to the start of the study. This includes several one-time meetings (kick-off meeting, boot camp, and investigator meeting) and frequent, ongoing conference calls (at best weekly, or sometimes monthly); frequent, regular meetings are an important aspect of teamwork. Additionally, the best results occur when a sponsor is consistently available for unplanned communication. Very often, quick turnaround is required for amendments to plans, resolutions for protocol ambiguities, and decisions about vendors; when the sponsor is not responsive, the timeline of the study can be affected. Good communication may be best achieved when there is a single, consistent representative from the sponsor who is always available to interact with the project manager from Biorasi.
- Handle FDA interactions.
The sponsor facilitates all regulatory approvals, such as the IND, for the clinical trial and any other communication with the FDA. It is very important for the sponsor to share the latest updates with their CRO in order to make sure the trial is fully compliant with all FDA directives and instructions. Failure to do so can be catastrophic for a drug development program.
- Review study documents carefully.
The sponsor should thoroughly review the study plans (communication plan, global project specification plan, monitoring plan, safety monitoring plan, data management plan, data validation plan, statistical analysis plan). Ideally, most of these should be completed and approved before the first participant is enrolled, since changing plans mid-course is significantly more difficult and can lead to serious delays or deviations.
- Manage sponsor-selected vendors.
The sponsor will oversee any vendors that are sponsor-selected. Part of Biorasi’s service to the sponsor includes selection and acquisition of vendors; however, it is not uncommon for sponsors to have preferences for certain vendors to use during the study. If that is the case, the sponsor undertakes responsibility for communication with the vendor and management of that relationship.
- Prepare for changes to the study budget.
Our budget is designed to be as accurate as possible from the beginning. However, unforeseeable changes can occur during the course of the study, including the addition of new vendors, protocol amendments, or additional site visits that can increase the cost of a study. The sponsor must acknowledge that some actions will lead to a change order that alters the original budget. Budget amendments are always at the discretion of the sponsor, and Biorasi works hard to negotiate with vendors to minimize costs. However, if necessary budget amendments are repeatedly rejected by the sponsor, the study can stall.
- Be GCP-compliant and audit-ready at all times.
All parties, including the sponsor, need to be GCP-compliant and audit-ready at all times. Biorasi’s CRAs keep tabs on site activities through frequent conversations with investigators and routine site visits. Biorasi monitors sites, the sponsor audits the sites and Biorasi, and the FDA audits all of us. This places the sponsor second to the FDA in terms of responsibility.
- Allow reasonable time for quality.
Sponsors should allow us an appropriate amount of time to deliver a quality product. This includes documents, monitoring visits, reports, etc. We work with sponsors to build timelines that are fast and thorough, but certain things cannot be delivered yesterday. If there are concerns about timelines, a conversation with a project director or manager can usually identify ways to shave some time and will result in better outcomes compared with trying to rush a process that shouldn’t be rushed.
- Keep to the study timeline.
Sponsors should make a good effort to keep to the study timeline, as everyone at Biorasi does. No one is above procrastination; it happens from time to time. Proper planning prevents poor performance, and a lot of delays can be avoided by responding to requests in a timely manner.
In exchange for these expectations, Biorasi promises to be transparent, professional, and vigilant alongside sponsors. Although part of the job of a CRO is to assume responsibility of the study, the sponsor holds the ultimate responsibility for a clinical trial, and it is very important for them to find the right CRO to share in this responsibility.
Our team members are invested in every study we run for our sponsors, since we equally desire success. Even so, it’s important to remember that a clinical trial is a team effort, and the sponsor is a vital part of that team. Following these guidelines, either with us or with any CRO, will help sponsors to make sure that their clinical trial has the best chance of success.