enClinical Trials
Our carefully selected and well-trained staff have extensive experience in designing and implementing 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, the EN ISO 14155 standard, 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 trials or we prepare comprehensive design and conduct a clinical trial tailored to your needs.
- 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 mainteinance of the Trial Master File (TMF)
- Preparation of the application for clinical trial approval by the ethics committee and competent authority
- Support in the process of the assessment of the application
- Registration of clinical trial in the database
- Preparation of the application for the amendment of the clinical trial
- Safety reporting
- Notification of the end, temporary halt or early termination of the clinical trial
- 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
- Preparation of a recruitment plan
- Labelling of the investigational product, preparation of import declaration, storing and distribution of the investigational product to the clinical trial sites
- Coordination and monitoring of the clinical trial
- Cooperation with experienced biostatisticians
- Complete data management
- Biostatistical data analysis
- Preparation of interim, safety and final report