- EudraCT Number Request
- Registration in Public Database
- Ethics Committee & Health Authorities
- Sites & Investigator's Agreements
If requested by the customer, before submitting the Clinical Trial Application, may apply for EU CT number from the Clinical Trials Information System (CTIS).
This number will identify the clinical trial conducted at a single site or at multiple sites in one or more member states.
may prepare protocol summaries for submission to public databases (e.g., www.clinicaltrials.gov).
team experience and knowledge of the regulatory process lead your project to the most efficient route to Ethics Committee (EC) and Regulatory submission and approval.
Start-up team has the information of EC requested documents for evaluation of a specific project and a strong relationship with the reference people at EC and Health Authority.
start-up team provides the prepared documents to participating investigators to get the signature in time for submission to the EC as well as the relevant documentation to be approved by the Sponsor:
- CTA completion (Clinical Trial Application)
- Documents to be provided (Insurance Certificates, Grant per patient, etc…)
- Evaluation fees
Our follow-up of the submission enable our customer to be updated about the foreseen processes and timelines. When receiving requests for information (RFI) about the study, we review and provide the sponsor our suggestions to the requested RFI. Once agreed with the customer, we submit the answer in time according to the regulatory calendar.
Once the IEC approve the project, each site manager signs an agreement with the sponsor to record each part responsibilities within the project.
start-up team drafts site contracts with study information for its revision and signature by the sponsor, site manager and investigator in the shortest timeframe.
has a long relationship with the reference people at each site for study agreement management. know-how and know-who optimize timelines in contract signature.