Why_Your_Clinical_Trials_Should_Include_Sites_in_Romania_Credevo

Best reasons to conduct clinical trials in any country include availability of patients, clarity of regulatory processes, willing and qualified investigators and a sound infrastructure with a reasonable cost. This is what you get if you conduct clinical trials in Romania. Let’s see this in greater details.

Why_Your_Clinical_Trials_Should_Include_Sites_in_Romania_Credevo

Brief Demography

Romania is a sovereign state located in Southeastern Europe near Bulgaria, Ukraine, Hungary, Serbia, and Moldova. It is a developing country, part of the European Union, and is rapidly growing. Romania has an economy predominantly based on services, and is cementing its reputation as an industrious, educated and ambitious region in many sectors. Romania has one of the larger populations in the region with over 22 million. About 55% of the population resides in the urban areas with major concentrations in the cities of Iasi, Timisoara, Constanta, Cluj-Napoca and Craiova.

Clinical Trials Status

Romania has a decent number of clinical trials to its share. Number of clinical trials is actually growing after economic changes in late 20 century.

Total number of studies in Romania (as per clinicaltrials.gov): 2115

Total number of recruiting studies in Romania (as per clinicaltrials.gov): 296

There are several clinical research organizations that now include Romania as their region of work. Most of these are international, if not global, CROs and serve to connect Romania with other regions of clinical research.

Clinical Trial Advantages

The increased interest in Romania for clinical trial is not without sound reasons. There are several factors that provide great advantages to Romania in conducting clinical trials.

Recruitment Advantage

  • High patient availability
  • Faster recruitment timelines

Expertise Advantages

  • High standards of medical education,
  • Highly concentrated and specialized healthcare services,
  • Experienced personnel (including eCRF and IVRS solutions),
  • Relevant expertise

Infrastructure Advantages

  • National infrastructure and environment,
  • Supportive infrastructure for clinical trials

Cost Advantages

  • Cost-efficiency in operations
  • Great competitive costs per patient

Quality Advantages

  • Good regulatory and protocol compliance with good-quality data
  • Sites certified by audits and inspections conducted by sponsor, regulatory or third parties.

Time Advantages

  • Trial start-up times and requirements which are comparable with other EU countries,
  • Clarity about regulatory timelines

Regulatory Advantages

  • Unambiguous regulatory conditions,
  • Synchronization with EU regulations
  • Almost all European guidelines and rules governing medicinal products in EU have been transposed into national legislation in Romania

How To Harness Romanian Advantages

With such a great proposition at hand, it’d only be a smart move to include Romania in all your clinical trial plannings.

Yes, it is true that you may not want all your projects in Romania all the times, but it helps to explore these projects in Romania for getting understanding about possible benefits and challenges. You can do it quickly and almost without any costs. Here is how to do it.

  1. Connect with Romanian investigators and sites
  2. Connect with clinical research organizations (CROs) and other service providers, and
  3. Understand the regulatory process

We discuss these in more details below.

Connect With Romanian Investigators and Sites

Conducting feasibility with investigators and sites is an established way to gather data about their experience, infrastructure, potential and cost. With Romanian investigators, it’s even easier since they’re mostly very responsive.

Credevo offers a convenient way to connect with Romanian Sites and Investigators. Here are the easy steps to do.

  1. Just sign up as a trial manager , if you’ve not already.
  2. Post your requirement with preliminary information, therapeutic segments and country (Romania, off course)
  3. Get responses from Romanian investigators.
  4. Start contacting these investigators and explore more.

Assessing feasibility with these investigators this way helps to get information about preliminary recruitment rates, responsiveness and possible number of sites that you can connect with. Further exploration with these investigators helps to assess the costs and other important considerations as well.

If there are any questions or thoughts about this, contact Credevo team here.

Connect With Clinical Research Organizations (CROs) and Other Service Providers

Not all trial management teams may be present physically in Romania, which may come across as a challenge. In these cases, you may want to connect with local CROs, who can be of great help.

There are a number of CROs working in Romania. These may be of Romanian, regional, or international origin.

You can either search these CROs through a simple google search or utilize Credevo to invite their proposals. This will help you get details without spending too much time or cost. Here is how you can do it.

  1. Just sign up as a trial manager , if you’ve not already.
  2. Post your requirements for CROs with preliminary details
  3. Get responses from different companies.
  4. Start contacting them and explore more.

If there are any questions or thoughts about this, contact Credevo team here.

Understand The Regulatory Process

The regulatory process for clinical trials approval in Romania is transparent and relatively fast.

Let’s discuss the regulatory process under 3 different kinds of approvals.

  1. Regulatory Authority (RA)
  2. Ethics Committee (IRB)
  3. Import Licence

Regulatory Authority (RA)

National Agency for Medicines and Medical Devices (NMMD) serves as the regulatory authority, governing the authorization of clinical trials in Romania.

Ethics Committee (IRB)

According to Ministry of Health Order 904/2006 on the implementation of good practices in the performance of clinical studies, clinical trial activities are not permitted without a favourable opinion from the the National Agency for Medicines and Medical Devices’ ethics committee. This ethics body (National Ethics Commission) serves as the IRB arm for approval of clinical trials.

Import License

Import approval of the study drug is no longer necessary, since the drugs are being imported based on the study approval.

Process Of Submission To RA & IRB

  1. The submission of the study documents can be done in parallel to both the competent regulatory authority (the National Medicines Agency) and the ethics body (National Ethics Commission), or applicant may request IRB opinion before filing a request for authorisation.
  2. According to National Agency for Medicines and Medical Devices Scientific Council Decision 2/2014, clinical studies must be performed in authorised units only.
  3. Unit authorisation is valid for two years and may be extended upon request.
  4. The scope of the authorisation, as well as the necessary documentation, differs according to the type of trial the solicitant wishes to conduct (eg, authorisation for clinical studies with therapeutic benefits, authorisation for Phase I clinical trials and authorisation for bioequivalence clinical trials).
  5. Applicant must notify RA by way of a signed letter of intent with regard to the payment of the authorisation fee and its intention to submit an application, at least two weeks in advance.
  6. Applicant must submit the documents listed in Annex 1 to Decision 6/2014 in electronic form. These documents include request for authorisation, opinion of the ethics committee, information about the sponsor and the medicine’s file.
  7. It’s strongly recommended for applicants not to bring any important amendments to the initial request after 50 days following the payment of the authorisation fee.
  8. The signed approval order indicates the institution where the study will be conducted, and the principal investigator responsible for conducting it.
  9. The authorisation for clinical studies is valid for the period of the study. However, it loses validity if the study does not begin within one year of authorisation being issued.
  10. RA needs to be informed about the study’s start date and any amendments to the study plan. Applicant must also notify RA when the study concludes.

Clinical_Trial_Application_Romania_Credevo

Figure 1

Time of Approval

  1. The applicant will receive information about validity of its request within 10 days of submission from RA.
  2. In case of appropriate documentation submitted, RA will issue an authorisation within a maximum of 60 days. The examination of an application submitted to the regulatory authority in proper format will not take more than 60 days.
  3. In case of refusal, the applicant may request that the agency revise this within 30 days.
  4. The ethics committee’s opinion will also be issued within 60 days of a request.

Cost of Submission

According to the authorisation procedure for conducting clinical studies by the National Agency for Medicines and Medical Devices Scientific Council’s Decision 6/2014, the issuance of an authorisation for performing clinical studies is subject to the following fee structure:

  • €1,250 for new substances;
  • €1,000 for clinical investigation of medicines not authorised in Romania but authorised in other countries or authorised for marketing, when the study is conducted with regard to aspects which fall outside the medicine’s summary of characteristics;
  • €410 for studies performed on products authorised in Romania, used in conformity with their summary of characteristics; and
  • €600 for bioequivalence studies.

More Information Needed?

Hopefully, above details will give a useful foundation to start exploring clinical trials in Romania. Should you need more information, utilize following channels to contact us.

  1. Our contact page
  2. Blue online chat widget on the lower right corner of this page
  3. Email: Helpdesk@credevo.com

References

  1. http://synevo-centrallabs.eu/media/docs/resources/JCS_March_2014_Clinical_Trials_in_Romania.pdf
  2. http://www.jforcs.com/wp-content/uploads/2015/05/09.-Romanias-Regulatory-Framework….pdf
  3. http://www.eurecnet.org/information/romania.html
  4. http://tangentdata.com/clinical_trials_in_romania
  5. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60372-3/fulltext
  6. http://www.efgcp.eu/Downloads/EFGCPReportFiles/Romania%20definitive.pdf
  7. https://www.lexology.com/library/detail.aspx?g=b85fa44a-4fd8-480e-9b5c-ddca500815ea

 

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