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 have conducted 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.