bring together study start-up activities and processes. Our study start-up team can navigate complex global regulations and collaborate directly with investigators and legal teams.
offers an extensive regulatory a airs study and expertise to support your team or insource complete regulatory a airs projects in an efficient and pragmatic manner.
The key challenge of a successful, timely study start-up requires careful coordination across multiple constituencies within and external to a research organization. As a result, it is easy to lose track of all the various steps necessary to activate a study efficiently and compliantly.
EU CT Number Request
If requested by the customer, before submitting the Clinical Trial Application, APICES can provide support to request the EU CT number from the Clinical Trials Information System (CTIS).
This will be the clinical trial identification number throughout the life of the trial in all Member States.
Sponsor, Sites & Investigator's Agreements
Once the IEC approves the project, each site manager signs an agreement with the sponsor to record each part responsibilities within the Project.
APICES 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.
APICES 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.
Registration in Public Database
APICES can manage the publication of clinical trials in public databases, including the publication of results (e.g., www.clinicaltrials.gov or EudraCT).
Ethics Committee & Health Authorities
APICES team experience and knowledge of the regulatory process lead your project to the most efficient route to submission and approval by Independent Ethics Committee (IEC) and Health Authorities
Start-up team has the information of IEC requested documents for evaluation of a specific project and a strong relationship with the reference people at IEC and Health Authorities.
APICES start-up team provides the prepared documents to participating investigators to get the signature in time for submission to the IEC as well as the relevant documentation to be approved by the Sponsor: completion of Clinical Trial Application in CTIS, documents to be provided (insurance certificates, grant per patient, etc…) and evaluation fees.
Our follow-up of the submission enables 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 sponsor, we submit the answer in time according to the regulatory calendar.
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