Josmedics, in partnership with DNA Technologies, a CRO company located in EUROPE with 30 years of experience in
conducting clinical research, specializes in clinical studies for medical device and pharmaceutical companies. Our
studies are carefully designed, produce high-quality data, and are reported with reliability.
Main Business Areas
Conducting Clinical Trials required for CE certification of Medical Devices
Carrying out PMCF studies of CE certified medical devices
Preparation of PMCF Plan, Study Protocol and Researcher's Brochure
Clinical Trial Data Management
Submissions to Regulatory Bodies
Organization of Legal Documents
Management and Organization of the Trial Sites
Supply Logistics / Import - Export Licenses / Product Storage
Local Insurance Coverage
DnA represent drug and medical device companies as a “legal representative” in all member states of the European Union for all drug and medical device trials to enable the submission of regulatory applications to the European authorities and ethics committees.
Feasibility data collected during the evaluation process is analyzed, summarized and prepared graphically. All supporting data that will help you to carry out your clinical research in the best way is presented to you in the Feasibility Evaluation Summary document. Based on study results, DnA provides information and data-based recommendations and recommendations regarding countries and the number of patients selected.
After the customer's approval, the Investigation Site is activated. DnA has extensive experience in activating investigation sites within a short period of time. Usual activities during the site activation process include the gathering of essential documents from sites and contract negotiation with hospitals and investigators.
We develop site budgets based on the study protocol and your approval. Working together with the project management we facilitate timely, accurate payments to investigators and organizations while delivering comprehensive, high-quality customer service to both you and the investigators. Our Investigator Grant database comprehensively tracks payments based on procedures performed, patient visits completed, milestone payments, and other measures as necessary. A grant payment summary is provided with each site payment.
It is carried out by our Clinical Research Associates in the field in accordance with the protocol. Clinical Research associates can perform all types of visits, reviews of regulatory documents, training of investigators, resolution of queries, and preparation of Corrective and Preventive Action Plans.
Why Work with Us
Ability to offer more economical budgets than other service providers based in Central Europe
Experienced Research Associates with diverse clinical backgrounds
Good relationships with the hospitals, medical doctors and clinics we work with, effective time management and low error/risk work protocols
Ability to create different application scenarios by mastering all European Regulation including Adriatic, Eastern Europe and Southeastern Europe local regulations
Clinical Studies conducted in Europe put you one step ahead of your competitors in entering the European and USA market
Possibility to publish your work in prestigious journals
Opportunity to work with key doctors in Europe.
For more information, please contact us at [email protected]