Medical devices

GCT has accumulated solid experience in managing clinical trials both for biopharmaceuticals and medical devices (see some very recent examples in the table below).
We know the sites which count hundreds in the region. GCT has established close relations with key opinion leaders in multiple therapeutic areas and is ready to recommend you the best combination in terms of recruitment speed and local regulations, geography and logistics, experience and costs (PI and site fees), equipment (CT/MRI, PET, etc.) and standards of treatment applied.

The EU market is the most attractive and most successful market for the Medical Devices trials, and through our EU locations we can conduct various Medical Devices projects.

Capacity and Interest on the Medical Devices R&D in Romania

With more than 40000 medical doctors, and 400 hospitals spread within the country and a centralized health system, Romania is a breeding ground for performing clinical studies in many indications and all categories of Medical Devices.

Few of the most attractive aspects of the clinical research in Romania are the high number of eligible patients, the high enrollment rates and fast recruitment.
Our Investigators offer decades of experience in clinical trials and based on their reliable assumption of enrollment rates we can manage each project in the most effective way. The interest and devotement of the research teams in the latest technology discoveries and their commitment to pursue the wellbeing of their patients is another key aspect of the Romanian market.

The compliance of the patients with the protocol and the specialized and GCP trained site personnel together with our experienced CRAs and Consultants lead to a successful result and a quality of data with minimum queries for the statistic department, reducing therefore the timelines even more.
Most recently we have started a project with a neurological implant device in Romania, where the Sponsor has increased the number of sites from 4 to 8, due to the interest and willingness to participate in the project of the study teams.

Romanian Market – Introduction on Regulatory

The legislation and regulations of the country are in line with the EU Directives and Guidelines and the principles of conducting the clinical trials are driven by the Declaration of Helsinki.

Romanian Competent Authority and Ethics Committee are two official bodies involved in running the clinical trials. There are national inspections programs in place, the authorities having their own standards of operating procedures, based on the Inspections chapter from the European legislation.

Even before adhering to the EU, Romania had a Bioethical Committee, from 1992 that became the National Ethics Committee for clinical trials in 1998. The rapid evolution of the regulatory framework in Romania by the transposal of the EU regulations into National legislation is one of the main reasons the clinical trials domain increased rapidly from 75 in 2004 to 1800 in 2015.

NMAMD, as the CA for Medical Devices in Romania, part of the Ministry of Health, is following closely the EU legislation in the clinical investigation regulatory framework, but in the MD domain the requirements and procedures vary from one State to another.

In order to approve the clinical investigations for Medical devices, the producer or its representative or delegate has to submit an official request to NMAMD, on the template from OMS no. 792/2006.

This official request must be accompanied by the documents requested in the 2nd Annex of the same Ministry of Health Order, with the specification that for each type of Medical device, the document list is different.

A short list of the clinical investigation/performance evaluation requested documents as by Romanian legislation:

• General information concerning the producer/representative; the reason for the request; other countries participating in the investigation/evaluation; declaration that the device is conformed with the essential requests
• Data to identify the device – commercial name, generic name, number and model number if it exists
• Other data concerning the device – classification, complete description including accessories, characteristics, previous experience results with any similar device by the same producer, risk-benefit analyses, materials description, preclinical data, mechanic testing, identification of any pharmacological components, biocompatibility and biological safety description, principle of functioning, diagrams, software description, conditions of use, methods of sterilization and validation, instructions for use, and others.
• Clinical investigation plan or performance evaluation plan -data about the investigators, centers, experience of sites and qualification, EC opinion, patients’ informed consent, insurance, scientific references
• Scope and reason, planning, patients number, duration of the trial, studied population, criteria, description and justification of incidents caused by invasive procedures, and general methods of diagnosis.
• Statistics, data management, description of final results to demonstrate the performance and safety, description of procedures and details concerning the registration and reporting of incidents, description and justification of statistical data, methods and analytical procedures
• Other – compensation for patients in case of an aggravation of their health.

What must be underlined is that along with the analysis of the technical part of the device, the medical benefits’ analysis is done by a Specialized Medical Committee from the Ministry of Health.

Based on the request and documents submitted following the mentioned Order, the NMAMD will authorize the beginning of the clinical investigation accordingly.
The clinical investigations must be performed in accordance with the Annex 10 of HG 54/2009 or of Annex
7 of HG 55/2009.

More information

We will be happy to provide more information about Medical Devices studies in CEE and Russia. Please contact us or simply use the form below. A representative will respond shortly.