Apices combines study start-up activities and processes. Our study start-up team works directly with investigators and legal teams to navigate complex global pharmaceutical regulations. We offer comprehensive study and expertise of regulatory affairs to support your team or, alternatively, undertake full regulatory affairs projects in-house.
Successful, timely study start-ups require careful coordination across constituencies both within and external to the research organisation. Because of this, sponsors can easily lose track of the various steps that are required to begin a study efficiently and compliantly.
Sponsor, Sites & Investigator’s Agreements
Once the Independent Ethics Committee (IEC) has approved a project, each site manager must sign a contract with the sponsor, in which they agree to record the responsibilities of each part in the project. APICES’ start-up team can draft site contracts with study information, which can then be reviewed and signed by the sponsor, site manager and investigator as soon as possible.
APICES maintains long-term relationships with reference people at each site in order to manage study agreements and ensure that contracts are signed to deadline.
EU CT Number Request
If the customer requests, APICES can ask for the EU CT number from the Clinical Trials Information System (CTIS) before a Clinical Trial Application is submitted. This acts as the clinical trial identification number over the course of the trial in all EU member states.
In addition, APICES can manage the publication of clinical trials in public databases, including the publication of results on sites such as clinicaltrials.gov or EudraCT.
Ethics Committee & Health Authorities
The APICES team’s experience and knowledge of the regulatory process allows us to guide projects to the most efficient routes to submission to, and approval from, the IEC and Health Authorities. Our start-up team has all relevant information ready to submit to the IEC to evaluate projects, as well as strong relationships with the reference people at IEC and Health Authorities.
APICES’ start-up team provides investigators with the prepared documents so they can be signed in time for submission to the IEC and for the Sponsor to approve the relevant documentation: Clinical Trial Application completion in CTIS, documents such as insurance certificates and grants per patient, and evaluation fees.
By following up the submission, we allow our customer to receive updates about the foreseen processes and timelines. When receiving requests for information about the study, we review them and give the sponsor suggestions for each request. Once it has been agreed with the sponsor, we submit the answer in time according to the regulatory calendar.