Clinical Studies of Efficacy and Safety (Phase III Clinical Trials) in Russia
Our department of clinical studies will deliver you full scope of services concerning Phase III clinical study projects in Russia - either participation of Russian centers in ongoing or planned Phase III clinical study or full scale multicenter clinical Phase III study in Russia.
All technical questions like biological samples logistics, additional laboratory tests, pharmacokinetic and/or genetic lab tests and screening, preparation of patient-friendly electronic CRFs in local language and many more.
I. Clinical trial project management in Russia
We provide full scope of clinical study management:
- Clinical study feasibility and timeline assessment;
- Clinical study timeline planning, determining milestones and KPIs;
- Clinical trial budget assessment and allocation;
- Choosing of the optimal clinical study centers that have official MoH permission for conduction of particular types of clinical studies;
- Thorough independent audit of clinical centers in order to satisfy possible FDA, EMEA and local MoH inspections;
- Assessment of clinical centers laboratory and diagnostic facilities;
- Coordination with institutional review board (IRB) / independent ethics committee (IEC)/ ethical review board (ERB);
- Clinical site initiation, start-up meetings;
- Managing monitoring visits, managing monitors and data managers;
- Clinical study data management, clinical study statistics management;
- Clinical site closing;
- Preparation of clinical study report according to Russian MoH requirements and ICH GCP guidelines;
- Adverse events (AE) management;
- Serious adverse events (SAE) and AE reporting according to GCP, international, local and sponsors' SOPs;
- Clinical site materials logistics, import/export permissions and customs clearance, coordination of logistics to/from a central laboratory;
- Submission of clinical study report to MoH.
II. Clinical study monitoring in Russia
For phase III clinical study we provide very experienced clinical research associates and clinical project managers for every study. Every clinical study monitor at Pharegis has dozens of successfully finished projects in clinical centers all over Russian Federation,
- Covering more than 40 major regional centers;
- Covering virtually all therapeutical profiles;
- Have database on primary investigators and current status of all centers;
- Have direct communication with primary investigators and centers administration.
III. Preparation of clinical study dossier and professional medical writing
Preparation of the clinical trial dossier is essential project since medical professional expertise, quality of medical writing as well as quality of professional translation are very important to both regulatory approval of clinical study and clear understanding of clinical study by investigators, study centers' administrative staff, laboratories, statisticians and data managers.
- Clinical study protocol that fully corresponds to regulatory requirements in Russia;
- Investigator brochure;
- Patient information sheet with informed consent;
- Case report forms (CRF), including eCRFs, translation and adaptation of sponsor's CRFs;
- Life and health insurance agreements with Ingosstrakh National insurance company for patients and volunteers (International patient insurance is not applicable in Russia);
- Clinical study report.
IV. Getting MoH regulatory approval for clinical study in Russia
- MoH regulatory approval for the clinical trial protocol;
- HA approval for patient informed consent;
- MoH ethical review board approval for clinical study in Russia;
- Clinical trial protocol amendments;
- MoH permissions for import and export of clinical study materials and more.
V. Data management and full-scope biostatistics management
VI. Clinical study materials logistics, storage and destruction
- Obtaining import and export MoH permissions for clinical study biological materials and equipment;
- Provision of cold chain conditions for biological samples logistics and storage;
- Cold chain monitoring;
- Customs clearance of biological samples logistics;
- Storage of clinical study biological materials and equipment.
- Destruction of materials according to GXP.
Contact us to get fast and free calculation of clinical study budget and timeline. After signing of the Confidentiality Agreement and getting project information from you, our consultants will analyze your project in detail and provide you working solution with clear perspective of further steps for your clinical study project in Russia.