Site Management

Investigator and site staff training

Appropriate training of investigators and site staff is key to your clinical trial’s success. The objective of such meetings is to educate the investigator and site staff on the investigational product, the background and the content of the protocol, the study conduct, event reporting, SAE reporting and GCP. Thorough training on these topics ensures that the investigator and site staff understand the policies and practices to conduct the trial in accordance with all applicable procedures, rules and regulations and it also provides an opportunity to elevate their interest in your clinical trial and boost performance.

We provide physician-to-physician guidance at every level, from recruitment to retention.

We also ensure that sites report high quality data and continuously monitor all available resources to detect safety and efficacy events that require independent review. ITREAS therefore actively promotes and supports best-practices at the site level by training sites on event reporting procedures, as well as diagnostic work-up, and taking remedial action where needed. This ensures short turn-around times, allowing Safety Boards and Endpoint Committees to monitor the core datasets continuously.

ITREAS can organize both on- and off-line investigator meetings and provide follow-up and refresher training sessions. This includes developing the content for the meeting and organization of the speakers, as well as more operational activities such as online hosting of the training (modules) or, in case of an off-line meeting, travel and accommodation.

Recruitment and retention

One of the most important goals of site management is to accelerate patient recruitment and to improve retention. ITREAS sets ambitious yet realistic recruitment expectations and ensures maintenance of recruitment at high enrolling sites and enhancement of recruitment at moderate and low enrolling sites. We closely monitor actual recruitment versus projected recruitment.

ITREAS can create GCP compliant patients tools which allow the site to objectively educate patients on the pro’s and con’s of participation in your clinical trial. Whereas much focus is placed on successful and timely patient recruitment, patient retention is just as important and ensures that you keep the patient interested, participating and committed to your clinical trial. This is key to ensure that patients are adequately followed-up and your dataset is clean and robust. We therefore also created tools that improve retention and avoid lost-to-follow-up patients.