Facts & Services
PHARMACEUTICALS:
• Cardiovascular disorders • CNS and psychiatric disorders • Orphan diseases • Gastrointestinal disorders • Oncology • Metabolic diseases • Endocrinology • Musculoskeletal diseases • Ophthalmology • Pulmonary hypertension • Rheumatology • Male fertility / Erectile dysfunction • and many others
MEDICAL DEVICES:
• Interventional radiology • Neurosurgery • Cardiosurgery • Cardiology & Cardiovascular disorders
PHASES:
• Preclinical • Phase I • Phase II • Phase III • Phase IV • clinical registries and PMCF
• Clinical Research (Phase I-IV) - including drug and medical device studies
• Site identification / Investigator recruitment / Feasibility Assessments
• Study setup (including investigator / hospital contract management)
• Preparation / translation / review of local language documents per local legislation
• Regulatory and ethics committee submissions
• Monitoring
• Project management
• Safety reporting
• Contract and Budget Negotiations in United Kingdom via NIHR CPMS systems
• Independent oversight / auditing of 3rd party monitors and CROs
• Regulatory support (including registration and marketing authorizations)
• e-CRF design, data management, e-CRF validation (via external partner)
• Organizing of investigator meetings and congresses
• Clinical research consulting
• Scientific expertise and consulting for pharmaceutical and medical device industry and biomedical research (including marketing and product registration)
• Regulatory consulting and support
• Local / country specific lab identification
• Identification of pre-clinical and phase I units
• Flexible CRO Solutions
• Exceptional Quality
• Personal Approach
• Regional knowledge
• Clinical research and consulting tailored to the needs of pharmaceutical and medical device companies
Company CLINITRIA was established in 1995 and it is fully specialized in clinical research since 2002.
CLINITRIA is member of SACROP - Slovak Association of Clinical Research Organizations and Professionals and EUCROF - European CRO Federation.
Our company and our research sites were several times audited by our clients´ internal and external auditors and inspectors from regulatory agencies with positive outcome.
Our activities are strictly based on ICH-GCP guidelines, EU directives, GDPR, local legislation and ethical principles.