Services
PRUDENTAS offers the following services for Phase I – IV trials in Russia and Ukraine:
- Study documents preparation
- Study Start-Up
- Regulatory support of the study
- Project Management
- Clinical trial monitoring
- GCP training for investigators
- Safety Monitoring
- Site Management
- Clinical Trial Logistics
- GCP Auditing, preparation for regulatory inspection, audits support
- Management (Subcontracting) of Russian Central Lab, Warehouse
- Subcontracting Data management and Biostatistics providers
GCP Auditing, preparation for regulatory inspection, audits support:
We have close partnership with leading Russian auditing company ClinQuality.
Management (subcontracting) of Russian Central Labs, Warehouse
We collaborate on a contractual basis with leading Laboratories and Warehouse in Moscow, which may be used as a Central Laboratory and Study Supplies Depot for our clinical trials. These vendors have up-to-date equipment, comprehensive SOPs, internal and external quality assessments and certificates, experienced in international clinical trials, may provide dedicated to specific study personnel.
Data management & Biostatistics providers:
We have partnership cooperation with providers of EDC tools, Data Management and Biostatistics.