Clinical Research Services and Consulting
Feasibility / Capability Research
Subjects Recruitment Management
Auditing
Phase I - IV Drug Studies
Clinical Trial Contract Management
Clinical Research Monitoring
Clinical / Medical Professionals Resourcing (Executive Search, Outsourcing)
Medical Device Studies
Ethics Committee / Regulatory Approval Management
Clinical Project Management
Translation Services
NEUROLOGY, CARDIOLOGY, ORTHOPEDICS, RHEUMATOLOGY, ONCOLOGY, HEMATOLOGY, UROLOGY, SPINE SURGERY, NEPHROLOGY, DERMATOLOGY, GASTROENTEROLOGY, ORPHAN DISEASES, etc.
Clinical Research Monitoring
- Site management and monitoring of clinical studies according to SOPs, ICH Guidelines and GCP and/or ISO
- Site Selection Visit (SSV)
- Site Initiation Visit (SIV)
- Site Monitoring Visit (SMV)
- Site Close-Out Visit (SCV)
Clinical Project Management
- Overall coordination and management of clinical trials from startup to closeout
- Direction of the technical, protocol-specific and operational aspects of clinical trials
- Collaboration with major functional areas to identify and evaluate fundamental issues on the project, data interpretation, business decisions to ensure an implementation of timely solutions
- Budget control, People management, Accurate forecasts
Clinical Trial Contract Management
- Preparation (or review), tracking and finalization of the clinical trial agreements inclusive of the study budget
- Negotiation of clinical trial agreements and budget, facilitation of coverage analysis and communication of relevant billing information to the research team and processing of all agreements for execution
Ethics Committee and Regulatory Approval Management
- Ethics Committee application / approval management
- Regulatory Authority application / approval management
Feasibility and Capability Research
- Clinical trial feasibility / capability research
Patient Recruitment Management
- Patient recruitment strategy preparation
- Follow up, tracking and improving patient recruitment rates
Clinical and Medical Professionals Resourcing (Outsourcing, Executive Search)
- Clinical / Medical Professionals outsourcing
- Clinical / Medical Professionals executive search
Translation Services
- Medical translation (English / Czech / Slovak)