Clinical Trials

Our carefully selected and well-trained staff have extensive experience in the design and implementation of a wide range of clinical trials in the field of:

Medical devices,
Food supplements and other foods,
Medicines.

We have established a strong and wide-reaching network of renowned experts, investigators and clinical sites in the Balkan region which together provide a rich treasury of knowledge, thus creating optimal results.

Clinical trials are conducted to demonstrate safety and/or efficacy of the product. They are performed in accordance with Regulation (EU) 2017/745 on medical devices (MDR), MDCG documents, standard EN ISO 14155, Regulation (EU) No 536/2014 on clinical trials of medicinal products for human use, guidelines for good clinical practice (GCP) and other regulatory requirements.

With proven efficacy, your products also gain added value on the market.

As a partner in clinical trials, we offer manufacturers of medical devices, foods (food supplements, novel foods, foods for special medical purposes, infant formulas) or medicines, local support and management of multinational clinical trial or we prepare comprehensive design and conduct of a clinical trial tailored to your needs.

Trial design

Preparation of the protocol
Sample size calculation and statistical analysis plan
Randomisation and blinding
Preparation of CRFs and other trial documentation
Preparation of ICF
Preparation and maintainance of Trial Master File (TMF)

Regulatory compliance

Preparation of the application for clinical trial approval for Ethics Committee and Competent Authority
Support in the proces of the assessment of the application
Registration of clinical trial in the database
Preparation of the application for the amandment of the clinical trial
Safety reporting
Notification of the end, temporary halt or early termination of the clinical trial

Clinical trial sites

Selection of clinical trial sites and principal investigators
Selection of laboratories
Cooperation with experienced investigators and laboratories
Training of clinical trial staff
Clinical trial sites management

Conduct

Preparation of a recruitment plan
Labelling of the investigational product, preparation of import declaration, storing and distribution of investigational product to the clinical trial sites
Coordination and monitoring of the clinical trial

Data management

Cooperation with experienced biostatistitians
Complete data management
Biostatistical data analysis
Preparation of interim, safety and final report