About us

Medical device clinical investigations without the fuss and worry

Services

From Protocol to Final Report through RA consultancy, Clinical Monitoring, Site Management, GxP Auditing, Bioanalysis (LC–MS/MS), Statistics and Data Management.

Market access expertise.
Our team of regulatory and quality experts adopt the most cost-effective approach in compliance with local regulations to get your medical device registered rapidly and efficiently. We also offer a range of industry-leading services designed to optimize the positioning of your product.
 Regulatory strategy development – Medical device registration in BDA and NHIF
Quality management systems
Local representation 

Network

Coverage of Bulgaria with access to healthcare facilities, Key Opinion Leaders and large patient database.

Clinical Research Center for Phase I Trials

Clinical Research Unit based in a University Hospital with large patient/ healthy volunteers database and extensive referral physicians’ network.

Scope of activity

We work with patients and doctors from all over Bulgaria

 

Sofia all hospitals
Plovdiv all hospitals
Varna all hospitals
E-mail: website@clinicaldata.eu

Therapeutic Areas

Highly skilled doctors awarded and certified by the most famous medical research universities around the globe, experienced by the most complicated cases they are here to help our patients.

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Services

The main scope of activity of the company is: Scientific research and

Development activities in the field of natural,

Medical, agricultural and technical sciences, etc.

The essence of the scientific and research activities will include:

Scientific research and

Development activities in the field of natural,

Medical, agricultural and technical sciences, etc.

The nature of the research covers:

Research and analysis of the success of operations


Marketing services and Business

Pilot studies of new for the market medical devices

Research, selection, processing and reporting of clinical data from laboratories and surgeries in the relevant medical fields

Market access expertise

Research, collection, analysis and reporting of information on rare diseases in Bulgaria and exploring innovative methods for treatment

Services

From Protocol to Final Report through RA consultancy, Clinical Monitoring, Site Management, GxP Auditing, Bioanalysis (LC-MS/MS), Statistics and Data Management.

Trial concept design and medical writing (study protocol to final report)

Monitoring of clinical trials (Phase I-IV in all indications)

Conduct of early phase trials (in patients or healthy volunteers) in our own University Hospital-based Clinical Research Unit for Phase I, BA/BE Studies

Site management

Biostatistics, data management, web-based clinical trial management systems (CTMS), EDC

Quality of Life Projects: translation, pilot testing, proofreading and validation

Epidemiological and Pharmaceutical Market Research

Medical device registration in BDA, electronic database and NHIF

Preparation of tender documentation for participation in hospital tenders and procedures of NHIF

Marketing Services and Business

Global clinical expertise with local monitoring for quality and project management.

Product training