The clinical trial process
Prior to the conducting of the clinical trial, the study must be approved by the Research Ethics Committee. Then a Site Initiation Visit (SIV) will be performed and the clinical staff (Medical Doctor, Research Nurses, Clinical Trials Assistant, Nutritionist, Research Technician etc.) will be updated on all aspects of the study. Our services include subject recruitment and screening, study conduct, electronic data capture, data and quality management and independent study monitoring
Study conduct and Electronic Data Capture (CRF & ePRO)
All study visits will be carried out at the Atlantia clinic site by the highly qualified and trained study team (Research Nurses, Clinical Trials Assistant, Nutritionist) and all blood reports, Adverse Events will be signed-off by the study Medical Doctor. Atlantia owns and operates our owns clinical sites, guaranteeing that the study protocol and processes are consistent throughout the study.
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.
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.
Independent study monitoring
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.
Study Product Manufacture and Packaging
Atlantia has capability to help companies with the production of trial product. We work from a food grade facility whereby we can prepare and manage your product needs. We can accommodate small batch production of capsules, bottling, labelling randomisation and boxing. We can also facilitate larger production and repacking tasks through our third-party network.