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

Clinical Trial Monitoring:

• Site Selection
• Site Qualification
• Site Initiation
• Routine site Monitoring visits
• Tracking of Query resolution process
• Site management
• Study Close-out

All site visits are performed in accordance with ICH GCP and SOP requirements, Monitoring Plan, Protocol and Sponsor Expectation. The result — high quality of data.

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GCP Training for Investigators:

Our monitors always provide ICH GCP training to investigators if selected sites are new to clinical trials and during Investigators Meeting.

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Safety Monitoring:

• SAE Reporting Assessment
• Interface with Data Safety Monitoring Boards (DSMB)
• Safety information distribution among investigators
• Safety notification to Regulatory Authorities/IEC

PRUDENTAS takes this responsibility seriously and gives special attention, oversight throughout the course of each study to ensure that patient safety is paramount, and patient risks are minimized.

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Site Management:

We ensure 24x7 availability for investigators. During the study, our team provides site support in:

• Study drug and non-drug supplies logistics
• Tracking regulatory document revisions;
• Tracking protocol deviations/violations,
• Tracking subject progression
• Site personnel training and guidance

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Clinical Trial Logistics:

PRUDENTAS offers to our clients clinical trial material logistics management services such as

• Obtaining of Import/Export License from Ministry of Health
• Customs documents preparation
• Import of Investigational Products/Comparators/Study Material, including laboratory kits and specific equipment
• Storage, distribution, re-labeling, return and destruction of Investigational Products/Comparators/Study Material
• Export of biological samples from clinical sites to Central Laboratory

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