WE.SPEED.
ARENSIA has dedicated regulatory departments with in-depth knowledge to successfully manage the submission process for clinical trials in:
Such expertise is of critical importance in the early phase space, considering that Phase I/II patient trials involve sophisticated protocol designs with novel therapies and which, case by case, imply the need of compensation schemes for the patients.
The regulatory authorities in above countries are highly supportive of clinical trials with exploratory/adaptive features and experienced in approving modern protocol design approaches such as integrated / umbrella / basket / platform trials.
ARENSIA offers its knowhow to submit clinical trials via the CTIS portal to other countries within EU (as a stand-alone capability), should the Sponsor plan to include/add additional countries/sites, along ARENSIA’s research clinics in Romania and/or Bulgaria.
Import/export of study supplies (IMP, laboratory kits, etc) as well as export of biological samples in each Romania, Bulgaria, Moldova, Georgia and Ukraine is well established and diligent. ARENSIA routinely manages all study related logistics in the most efficient way.
Through the local laboratories in Romania/Bulgaria ARENSIA can support Immunohistochemistry (IHC) in compliance with the In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR).
In Romania and Bulgaria (EU countries) the regulatory approval process takes 60 days. Since 31st of January 2023, Romania and Bulgaria have implemented the new EU Regulation 536/2014. This implies that all initial submissions involving these 2 countries, same as in all EU countries, will be performed centrally as a single on-line application into the Clinical Trial Information System (CTIS) having a reporting member state as lead reviewer.
In Moldova the regulatory approval process takes 15 days for Phase I trials and 30 days for Phase II-III trials. The review is performed in parallel by Health Authority and National Ethics Committee. Moldova is an EU-candidate country thus the submission package is similar to the one in the EU countries.
In Georgia the regulatory approval process takes 30 days. Georgia is an EU-associated country thus the submission package is similar to the one in the EU countries. The review by the Local Ethics Committee takes 10 business days, followed by the review of the Health Authority which takes 20 days.
In Ukraine, the regulatory approval process takes 35 days. Ukraine is an EU-candidate country requiring CTA Form equivalent and the set of documents very similar to the EU package. The submission of the documents is done in parallel to the Regulatory Authority (State Expert Center (SEC)) and Local Ethics Committee (LEC). The expert evaluation of an application dossier submitted to the SEC, in validated format, takes 30 calendar days. The conclusion given by the SEC is approved by the Ministry of Health (up to 5 calendar days). The assessment of an application dossier submitted to the LEC, in validated format, takes 30 calendar days.