Services

PRUDENTAS offers the following services for Phase I – IV trials in Russia and Ukraine:

Study documents preparation:

Translation of study documents provided by Sponsor into local language
Clinical Trial Protocol and Protocol Amendments writing
Informed Consent Form preparation / adaptation in accordance with local Regulatory and Ethics requirements
Writing Investigator Brochure and updates
Clinical study report preparation
Case Report Forms design (including electronic ones)

The pivotal role in performing a successful clinical trial is to have a well-prepared, consistent study documents. PRUDENTAS has a large experience in preparation/translation/adaptation of clinical trial documents fulfilling the GCP guidelines.

Study Start-Up

PRUDENTAS understands that proper planning is a key to conducting a successful trial. Our experienced clinical team using extensive database of investigators throughout the country provides our clients with the necessary enrollment strategies, timelines and site selections to efficiently initiate a trial.

Feasibility
Site selection
Regulatory and Ethic Committees Approval
Investigator Meetings
Site Regulatory documents collection and review

Regulatory Support of the Study:

Thorough preparation and multilevel review of study documents, extensive expertise in working with regulatory authorities, constant tracking the documents during the approval process allow our company to obtain Regulatory Approval in the shortest terms. The result — quick start up of the study: cost efficiency for Sponsor

Clinical Trial Dossier preparation and submission to Independent Ethic Committees (IEC) and Regulatory Authorities (RA)
Obtaining the local Insurance Policy
Obtaining Import/Export licenses for study drug and non-drug supplies
Safety reporting in accordance with ICH GCP and local regulations
Timely submission of all study specific documents to EC and / or RAs (per local regulations and GCP requirements) during the study

Project Management

Project Management, including, but not limited to:

Developing study specific Project Management and Monitoring Plans
Subcontracting of local Central Labs, Warehouse and other vendors depending on study needs;
Subcontracting providers of EDC tools, Data Management and Biostatistics
Investigators Meeting planning, organization and conduct
Regular project status tracking and reporting to clients
Budget negotiation and contract execution with study sites
Study Team kick-off and interim F2F meetings planning, organization and conduct