The TMF is the official record of the clinical study for Regulatory Authorities, be it…
During a recent meeting with a sponsor, I was asked whether our clinical research associates (CRAs) were assigned by site, meaning they work on different trials but only at specific sites, or by clinical trial, whereby they cover all sites for a particular study.
Larger, full-service CROs tend to assign CRAs to new trials based mainly on their overall workload, with no real consideration for therapeutic experience, or which sites will be involved and where they are located. In fact, it is not uncommon for large CROs to assign their trial monitors to a study “start-up team” well ahead of the site selection process. CRAs tend to be a pooled resource, graded on their percentage of Full-time Equivalent (FTE) availability or their ability to take on more projects. While this strategy of allocating CRAs on a per trial basis is a common practice in the industry, it does have certain disadvantages – the most important one being the inability to develop trusted relationships with the sites.
As a specialty oncology CRO dedicated to attracting novel oncology compounds and clinical trials to Canada, we have CRAs located throughout Canada. Site assignments are completed only once we have a good idea which provinces and sites are likely to be involved in a given project. While this method is partly due to our costing strategy, it has the added benefit of allowing our CRAs to leverage existing relationships with study site personnel. Our Oncology and Canadian focus means that our CRAs repeatedly work with the same sites on various trials. They get to know the site’s personnel very well, and in most cases are familiar with the sites’ internal procedures.
It’s these relationships that help form strong partnerships between the sites, the CRO and the trial sponsors, because it leads to improved reciprocity, quicker feedback and better results. Conversely, larger CROs often have a harder time getting on the investigator’s radar because their CRAs are constantly being moved around.
Do you have any oncology clinical operations questions you’d like answered? If so, please share your comments below. We’d love to hear about your oncology trial expansion experiences and strategies that have worked for your company.
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P.S. Thanks to our Oncology Clinical Trial Leader, J. Martin for her contribution to this post.