Our unique model maximises control, reduces the risk of data inconsistency, and brings a sense of assurance to our clients dealing with one competent organisation as opposed multiple contract research organisations.
Unless otherwise stipulated by Sponsor, remote monitoring will be performed by an Independent Clinical Trials Associate and will involve 100% review of Participant Information Sheet/Informed Consent Forms and source documents/eCRF data relating to the primary endpoint, and 20% monitoring will be performed on all secondary endpoints. Monitoring reports will be provided to the sponsor throughout the study, with updates on recruitment, subjects randomised, study visits completed and protocol deviations.
The above is the standard monitoring level provided by our team, however other monitoring levels can be discussed depending on the sponsors’ needs. The Monitor will make provision to spend sufficient time with study staff during the visits to discuss and resolve queries that may have arisen during monitoring.
If the Monitor raises questions on the eCRF and queries cannot be resolved during the visit, the Monitor will record this in the monitoring report and ensure same has been addressed by or before the next visit. A Monitoring Visit Report will be completed and sent to Sponsor. All original monitoring Visit Reports will be printed and retained at site until study closure after which they will be sent to Sponsor.
A well-established Quality Management System (QMS) is integral to all aspects of clinical trials and ultimately, the safety and wellbeing of trial participants. A robust QMS ensures that appropriate manufacturing standards have been adhered to in the production of investigational Product as well as ensuring ICH-GCP and company procedures are adhered to during the conduction of a study. Quality Management ensures all the necessary steps have been taken to ensure the end-product/data is clean, reliable and accurate. This includes staff training, continuous improvement and trial documentation control and storage.
The role of Data Management is increasing as clinical trials management moves towards risk-based approaches. The most important aims of GCP are to ensure that subjects who take part in clinical trials are protected and that the data collected are reliable. The new EU Regulation (GDPR) has also set additional constraints to clinical research.
With the increasing use of computerized systems in clinical trials, both European Medicines Agency & FDA have issued guidelines on electronic source. The two main objectives of Data Managers roles in Clinical trials are to ensure data quality and integrity.
Atlantia uses an electronic data capture system to collect study data for each volunteer. Data is entered in real time and monitored both internally and by our external data monitor. Our clients have access to view data in real-time throughout the study. Once the last subject completes the last visit, data cleaning and management will commence. Upon completion of the study, the PI will sign-off on the eCRF and the locked database will be sent to the sponsor.