Phase II.-IV Clinical Trials
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. In direct contact with key opinion leaders a thorough feasibility analysis including investigator interest, predicted number of eligibile subjects, previous experience, staff and facilities availability, assists our clients in their strategic plans for clinical trials in this region.
Site Selection Site selection procedures and criteria are well defined by the SmartMedico ltd's 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 for obtaining Ethics Committee and Regulatory approvals 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 to participate in clinical trials providing a new medicine in their area of expertise with a structured organization and coordination of the trial by SmartMedico . Investigators are motivated by more than just the financial reward to take part in a clinical trial and perform well. Co-operating with US companies in scientific research is a sign of merit — it is well known that only the best candidates are selected. Finding the proper grants and negotiating the share split between the hospital and investigator can be a key success factor of the trial.
Project Management Project Management is governed by strict implementation of processes to ensure quality of the project and tight budget and time controls. Our project manager is a fully dedicated extended part of your team with continuous communication on the project progress in all project phases – from feasibility analysis, site selection, regulatory application and approvals obtaining, budget and contract negotiation and execution, study initiation, conduct, monitoring and closing, as well as quality control and quality assurance.
Clinical Monitoring SmartMedico offers a high quality monitoring service ensuring ICH GCP compliance and data integrity in adherence with study monitoring plan. Besides overall clinical trial site management, SmartMedico performs:
- pre-study visits
- local investigator meetings
- site initiation visits
- site organization and management including site coordination services
- protocol and ICH GCP compliance verification
- ongoing training of site personnel
- site monitoring/comonitoring
- study supplies and investigational product records management
- regulatory documents maintenance
- close out visits
- logistic handling
- timely query resolution
SmartMedico’s inhouse training program ensures the competency of each role within clinical monitoring and includes:
- Clinical Trials – History, Phases, Basic considerations
- GCP, Declaration of Helsinki, FDA, EMEA, EU Directive, Ethics Committees
- Clinical Trial Regulation in Croatia
- Clinical Trial Related Documents, Site Selection, Site Initiation
- Clinical Trial Monitoring A
- Clinical Trial Monitoring B
- SmartMedico’s SOP, Communication in multinational environment, How to be a successful CRA