monitoring team is led by an experienced Clinical Operations Manager and coordinated by lead managers who take care, give support and supervise every activity and the implementation of the action plans discussed with the Project Manager.
Every Clinical Team is focused on getting the highest quality of data and GCP/GPP/ISO14155:2011, as applicable, compliance from all personnel involved in the study. Our CRAs are trained to support and solve any difficult situation at site working closely with the investigator staff. All our CRAs receive training on therapeutics from medical specialists, clinical research methodology, standard operating procedures and updates on research legislation to ensure quality deliverables. We offer our expertise and global resources to reach the goals of projects of any size and complexity and with international coverage.
services of clinical monitoring cover:
Development of a Monitoring Plan within the parameters agreed with the customer through the budget proposal and service contract, detailing the applicable SOP, frequency of monitoring and specific instructions of the project.
It includes Contingency Plans for any study timeline deviation.
Once we have got the local approvals and authorizations and meeting time and expectations of our customers, monitors ensure that the investigator staff are trained and with all necessary materials to the study start and getting the agreement with the investigator for the shortest date for the first patient inclusion.
Monitoring Visits are performed by CRAs to oversee the progress of the clinical study and ensure that it is conducted, registered and reported in accordance with the following principles:
- The rights and well-being of human study subjects are protected.
- The reported data makes sense, is accurate, complete, and verifiable from source documents.
- The conduct of the study is in compliance with the currently approved protocol/amendment(s), with GCP, GPP and/or with the applicable regulatory requirement(s).
A Monitoring Report is written after each visit documenting all findings. Protocol deviations are managed according to applicable legislation.
Further follow up is performed by the CRA until all site pending issues are resolved.
has in place a complete set of tools designed for an efficient site management and study monitoring, optimizing resources and ensures keeping the study under control.
may use strategies for monitoring activities that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively.
The use of centralized monitoring methods improves sponsor’s ability to ensure the quality of clinical trial data, reducing costs, supplementing or reducing the frequency and extent of on-site monitoring with monitoring activities that can be done as well or better remotely or with monitoring activities that can be accomplished using centralized processes only.
On-site monitoring may also be targeted by identifying higher risk clinical sites (e.g., sites with data anomalies or a higher frequency of errors, protocol violations, or dropouts relative to other sites), through the activities described above. Such findings, whether related to critical or non-critical data, may warrant more intensive and consideration of on-site monitoring.
Every study site should be closed, in accordance with the customer to ensure all the patient information has been collected, all the documentation are kept in the Investigator Study File, the study materials and all the study drugs are returned to the sponsor and the principal investigator has clear information about their responsibilities and the policy of publication and records retention. All the services involved and other site parties (IEC) must have a closure letter informing about the site closure.