Clinical Trial Authorization Applications

With the Clinical Trial Regulation coming into effect, the Sponsor now has increased responsibility and involvement in the management of their clinical trials. This includes access control in the Sponsor environment of the Clinical Trial Information System (CTIS) used for Clinical Trial Authorization Applications in Europe. DADA can take on the role of Clinical Trial Administrator on behalf of the sponsor and manage the Clinical Trial Authorization Application from the Sponsors end, communicating with the Contract Research Organisation on behalf of the Sponsor and managing the responses to requests for information received via CTIS from Competent Authorities.

Additionally, DADA can manage the transition of trials that have been approved under the Clinical Trial Directive, so that they are compliant with the Clinical Trial Regulation if they are foreseen to be still running by 31 January 2025.

DADA can also handle the submission of clinical study reports and perform clinical trial pharmacovigilance, including the submission of annual safety reports.