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.

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