“As the clinical trials in humans are very sensitive, the regulatory aspects need to be planned and managed on high professional level taking into account the changing EU regulatory patterns. The capacity and knowledge dedicated in this area are the crucial pillar of success for any clinical trial.”
To provide service support for complex clinical trials, offer knowledge, experience, expertise and professionalism to partners who are interested in conducting effective clinical trials involving medicinal products, medical devices and new treatment methods in the EU.
· To provide "one-stop-shop" for clinical trials of all phases
· The preparation, implementation, conduction and evaluation of the clinical trials from Phase I - IV in any medical field in the Czech Republic and in other EU countries.
Single point access to the capacity and expertise
· Access to university hospitals and healthcare provider facilities, clinical researchers and patients
· Clinical Trials coordination across the whole project network
Implementation of the clinical trials
· Methodological support for clinical trials
- Medical writing
· Start-up Phase, legislative support
· Regulatory support and submission
· Biometry (data management, biostatistics)
· Clinical Trials Monitoring and Pharmacovigilance
Control and quality assurance
· Support of the creation of the systematic and proper management of the projects in accordance with the requirements of relevant legislation and guidelines
· Creating a basic set of sample Standard Operating Procedures (SOPs) for the processes
· Consultations on the formation of QA/QC
· Quality system/ GCP Audits
Management of the Clinical trials
Our organizational structure and comprehensive skilled team enables us to act as a sponsor of a clinical trial or as an authorized CRO (contracted by the sponsor, which according to the contract assumes one or more of extensive responsibilities and obligations of the sponsor).