Feasibility Analysis

We proactively assist every clinical aspect of the trial and evaluate the feasibility based on our previous experience, hospital databases and interviews with clinical experts.

 

Site Selection

Site selection procedures and criteria are well defined by the HT SOP, which guarantees the involvement of sites with the best patient recruitment potential and ensures good GCP compliance.

 

Regulatory and EC Affairs Management

The regulation of clinical trials in the Central and Eastern European countries is being co- ordinated through EU directives. Regulatory acts are often changing, therefore local expertise is essential.

 

Hospital and Investigator Grant Negotiation

Although investigator fees in Central Eastern Europe are significantly lower than those in the EU or in the US, investigators in the region are still motivated by the opportunity, because of the low earning potential in the health care sector. Finding the proper grants and negotiating the share split between the hospital and investigator can be a key success factor of the trial.

 

Monitoring

HungaroTrial’s well-trained CRA team is able to work under deadline pressure. Some of the CRAs have already achieved international (ACRP) qualification.