Clinical Operations

CAP’s mission is to deliver effective, end-to-end resource planning, collaboration and training for your oncology or oncology supportive care clinical trial.

We have the experience, drive, and the site, investigator and vendor relationships essential for today’s fast-paced study start-up timelines and complicated regulatory environment. Our dedicated team acts as an extension of the sponsor’s team and provides superior, seamless support at every stage of the drug development process. We care about and are committed to clinical trial success.

From study feasibility and site selection to study close-out, we deliver a holistic, well-coordinated and collaborative approach to produce a superior clinical trial environment.

CAP’s clinical operations support services include:

Timeline Creation and Analysis.
An accurate study timeline ensures the study begins on time and sites are initiated in a manner consistent with expectations. We work with each client to customize the study timeline, making pointed recommendations, where possible, to shorten the overall timeline, and providing indication-specific expertise to ensure a collaborative and personal relationship with both the client and potential study sites.

Feasibility, Site Selection & Qualification.
We work with clients to quickly develop a detailed, indication-focused, site feasibility questionnaire that allows for rapid and highly reliable site pre-qualification ensuring a more robust rate of qualification of sites and also increasing the probability that approved sites will meet accrual expectations. We have extensive and long-standing relationships with countless study coordinators and investigators at hundreds of sites with directly-relevant oncology trial experience. In addition, CAP has an extensive database of clinical sites active in oncology research, many of whom have been active in previous studies managed by CAP. We don’t waste time cold calling traditional oncology sites looking for interest – we already know which sites are relevant, and better yet, which sites are known for reasonable accrual potential and good data quality in the relevant study population.

Site Management & Monitoring.
As a gateway to study participants, one of the most valuable assets in a clinical study are the sites. CAP works diligently to ensure site staff feel as though they are a part of the study team. By thoroughly knowing the study protocol and communicating with site staff frequently, CAP is able to guide sites to the best performance possible. Site staff learn quickly that their CAP team members are well-informed, professional, and quickly available by phone. With the CAP internal staff handling site management, our clinical monitors are focused on source data verification. CAP stresses indication and protocol training for every CRA. In addition, we focus on team communication in order minimize monitoring variability and keep CRA turnover low.

Collection, review, and approval of site essential documents.

IRB/EC submission assistance.

Set-up and maintenance of the TMF.