Through our IPharma division, ChemDiv supports drug development in Russia. Our highly experienced team of clinical, medical, regulatory, and QA personnel has strong relationships with Key Opinion Leaders and Principal Investigators throughout Russia. We haveconducted Phase I-IV studies in a wide range of therapeutic indications, including CNS, oncology, endocrinology, cardiology, gastroenterology, respiratory, autoimmune disorders, viral infections, and others. We have especially strong expertise in early stage trials. All work is conducted according to GCP standards and follows applicable SOPs and regulatory guidelines.
The range of our Clinical Services includes (but is not limited to):
Overall project management, protocol development, clinical monitoring, regulatory support, medical writing, and vendor management services
Consultation and strategy provision to gain Russian market access for new drugs not yet registered in Russia
Drug registration support including dossier preparation, clinical trial development and conduct, and market approval application
We have worked with most major pharmaceutical and many smaller biotech companies; and often work alongside other CROs to increase study recruitment. Our medical department offers complimentary feasibility assessments to determine estimated enrollment. We work closely with Sponsor companies to meet their study timelines at their desired budgets.
Please contact our team at [email protected] to discuss your specific needs and application.
Take a Look at ChemDiv’s Drug Development Services:/h3>
Clinical Trial Monitoring
The majority of the Clinical Research Associates (CRAs or monitors) at our company are MDs. By utilizing medical doctors, the overview of medical charts and the rapport with investigators is of the highest quality, thereby assuring our clients that the patients included in the research trial are enrolled appropriately and their safety and well-being is given the utmost importance. Consequently safety and data validity are ensured. The CRAs manage their sites including training site staff on protocol requirements and verifying that the clinical trial is conducted under Good Clinical Practice (GCP). CRAs conduct initiation, routine monitoring and close out visits to all sites involved in a study. All research conducted by the Russian investigators are under ICH (International Code of Harmonization) and GCP standards thereby assuring excellent data quality. In sum, our monitoring includes:
Site Selection and Qualification in accordance with Protocol and ICH GCP requirements
Routine site Monitoring per Monitoring Plan and Sponsor Expectation to provide high Quality of data retrieved
Tracking of Query resolution process
Study logistics management
In addition, we oversee:
Study drug and non-drug supplies logistics
Tracking regulatory document revisions
Tracking protocol deviations/violations
Tracking subject progression
Clinical Trial Management
IPHARMA, ChemDiv’s clinical division, can manage all aspects of a clinical trial in Russia. When a sponsor company is considering enrolling patients in Russia, our Medical Department can conduct a complimentary feasibility assessment to determine estimated enrollment numbers and timelines.
If needed, we can craft a study protocol for review, approval, and finalization. Once a study is awarded to ChemDiv, our study team can begin amassing documents for the regulatory dossier to be submitted to the Ministry of Health. We track all aspects of study progression and communicate this information to our clients.
Our study teams consist of Project Managers (PMs), responsible for all aspects of the study, who act as primary contacts to the sponsor company (and internally)
Our PMs oversee our teams of Clinical Research Associates (CRAs), and work closely with our medical team
Depending on the needs of the sponsor, our PMs can also manage vendors
Upon study award, we devise monitoring and communication plans and contact lists
Our clinical and medical team works closely with the sites to ensure that all staff are trained extremely carefully
We work closely with our clients to ensure that the information that is most helpful to them is provided in a timely fashion; and do everything possible to ensure that data are of the highest quality
ChemDiv’s IPharma clinical research division very knowledgeable and experienced with clinical trial requirements in Russia. In addition to conducting Phase I to Phase IV multi-national studies for European and US companies, we have extensive experience conducting early phase studies for companies domiciled in Russia.
The QA division of ChemDiv’s clinical research division, IPharma, is highly experienced in vendor, site, CRO, and drug depot audits. Each of the trials that we conduct undergoes independent audit whether an audit has been included in the study budget or not. Our QA team implements effective training and crafts SOPs compliant with GCP and ICH regulations. We conduct regular co-monitoring visits with our CRAs, and verify case report forms to ensure that trials are conducted to very high quality standards.
Take a Look at ChemDiv’s Quarter of a Century Track Record