The Clinical Research Associate (CRA) according to the GCP definition stands for the “person delegated by the Sponsor to organize, follow and control the progress of the clinical study at the experimental centers”. This figure covers the role of mediator between the Sponsor, generally a pharmaceutical company that commissions the clinical study for the development or marketing of its molecule, and the experimental center.

The professional figure of the CRA outlines a complex role since they are required transversal skills and personal characteristics to fulfill the numerous activities entrusted to them.

The CRA starts the experimentation assigned through the processes defined as “Feasibility” (that is to say practicability of the study and “Site selection” (selection of the experimental centers when requested by the Sponsor).

In this phase, the CRA, together with the Sponsor, selects the most suitable experimental centers for the study by offering them the opportunity to participate in the clinical trial, carefully evaluating their feasibility both in terms of organic resources, structures and technical equipment and arranges everything necessary for the study to begin and proceed in line with the GCPs, SOPs and regulations in force.

Following the approval of the necessary documentation by the relevant bodies (Regulatory Authorities, Independent Ethics Committees), the CRA will conduct a Site Initiation Visit providing specific training to the principal investigator and its team regarding the study protocol and all relating procedures, GCP, source documents, characteristics of the drug/s under study and everything related to it, registration of AE / SAE / Pregnancy and much more, to be respected during the conduct of the entire clinical study.

On a variable basis, depending on the reference SOPs and the specific study documents, he/she will carry out periodic monitoring visits to the center in charge until the end of the trial itself, personally verifying the activity of the personnel involved and ensuring that the work is executed correctly. During the monitoring visits, the CRA ensures that the process of submitting the informed consent of the study has taken place according to the procedures established by the GCP; that the data entered in the study data collection forms (CRF / eCRF) are congruent with what is reported in the center’s source documents (medical records and all documents relating to patient visits to the centers themselves); he/she also ensures that the study documentation is adequately maintained for the entire duration of the study and for as long as required by current regulations. Once the monitoring visit is completed, the CRA is required to produce a detailed report to the Sponsor listing the activities carried out during the visit.

OPIS’s twenty years’ experience in the management and monitoring of clinical trials and the competent and well-trained staff of Clinical Operations ensure high standards as for the services offered.

Our Project Managers have great professional skills and can manage complex clinical trials. They act as the main point of contact for the Sponsor, ensuring agile communication between all parties involved in the study. Responsibilities and reporting lines are clearly defined in the early stages of the project. Our Project Managers guarantee the execution of activities in accordance with the contract and all applicable requirements, maintaining the highest quality standards and ensuring compliance with deadlines. In addition, our Project Managers are responsible for overseeing the monitoring activities and study progress, including a 100% review of all monitoring reports and a periodic review of study documentation.
We have a large network of experienced CRAs covering over 30 countries.

All CRAs are fluent in English and have excellent knowledge of ICH GCP R2, the local context and related medical practices. Monitoring models include site visits and remote data review. The combination of visits to the center and remote monitoring is proposed during the contract negotiation phase for the complete supervision of the progress of the study at the centers involved. The risk-based adaptive approach in monitoring clinical trials represents a valid method in order to facilitate the implementation of more efficient systems for conducting and supervising clinical trials.