Regulatory requirements are continually evolving and furthermore vary from region to region. To get the right regulatory strategy and the different activities required across participating countries to undertake clinical trials in line with all national guidelines extensive experience and local know-how is required. Exom’s clinical operations team brings the required expertise to your clinical project. Operating in various geographical regions, utilizing internal experts or external cooperation partners from our Exom Alliance, we guide you through the challenging regulatory approval process and ensure that you have all necessary documents in place – on time. Our staff knows the mentality of all involved stakeholders in their geographical area by heart to ensure a smooth approval process for your study.
What we offer for your Clinical Trial Application
- Submissions of Clinical Trials Phase I-IV as well as non-intervantional trials in accordance with the EMA, FDA and other Regulatory Authority Regulations and ICH-GCP
- Submissions of international trials are also made by local expert teams also aware of the local regulations and who works in collaboration with the study manager and the Start-up Specialist Team, responsible for the preparation of the core study regulatory package
- Submission to National CAs and local ECs / IRBs
- Response to deficiency letters
- Preparation and finalization of the financial agreements with study sites.
- Preparation of non-substantive and substantive amendments in collaboration with the medical writing team
- Notification to local authorities as required
- Registration of Clinical Trials in EUDRA-CT and other national registries
- Regular tracking of submission and approval status
- Preparation of end-of-trial declarations