WE.SPEED.
ARENSIA has dedicated regulatory departments with in-depth knowledge to successfully manage the submission process for clinical trials in:
USA (collaboration with an experienced, well-known IRB)
Romania, Bulgaria (EU countries, following the Clinical Trials Regulation 536/2014 where studies are submitted via single entry CTIS portal in the EU)
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 which, case by case, imply the need for compensation schemes for the patients.
The regulatory authorities in the 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 the 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.
In Europe, ARENSIA performs the regulatory submission to all involved bodies (Health Authorities and Ethics Committees). In the USA, ARENSIA only performs the submission to the IRB.
In Romania (EU country) the regulatory approval process takes 60 days. Since the 31st of January 2023, Romania has implemented the new EU Regulation 536/2014. This implies that all initial submissions involving this country, same as in all EU countries, will be performed centrally as a single online application into the Clinical Trial Information System (CTIS) having a reporting member state as lead reviewer.
In Bulgaria (EU country) the regulatory approval process takes 60 days. Since 31st of January 2023, Bulgaria has implemented the new EU Regulation 536/2014. This implies that all initial submissions involving this country, same as in all EU countries, will be performed centrally as a single online application into the Clinical Trial Information System (CTIS) having a reporting member state as lead reviewer.
In Moldova, the regulatory approval process for Phase I-III trials takes 10 working days upon the applicant's request for expedited review. Standard review procedures require 30 days. The review is conducted concurrently by the Health Authority and the National Ethics Committee. Moldova is an EU candidate country; thus, the submission package is comparable to that of EU countries.
In Georgia, the regulatory approval process takes 30 days. Georgia is an EU-associated country; thus, the submission package is comparable to that of 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 typically spans 35 days. As an EU-candidate country, Ukraine requires a CTA Form equivalent, and the set of documents mirrors that of the EU package. The submission of documents occurs concurrently to both the Regulatory Authority (State Expert Center (SEC)) and the Local Ethics Committee (LEC). The expert evaluation of an application dossier submitted to the SEC, in a validated format, is completed within 30 calendar days. The conclusion provided by the SEC is then approved by the Ministry of Health within up to 5 calendar days. Similarly, the assessment of an application dossier submitted to the LEC, in a validated format, also takes 30 calendar days.
In USA, ARENSIA performs the submission to IRB only. We collaborate with an experienced, commercial IRB. Review timelines are 1-2 weeks.