Services

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

Study documents preparation:

  • Clinical Trial Protocol writing
  • Informed Consent Form preparation / adaptation in accordance with local Regulatory and Ethics requirements
  • Creation of Data Collection Forms (including electronic ones)

Regulatory Support of the Study:

Review of documents provided by Sponsor

  • Clinical Trial Dossier preparation for submission to Ethic Committees and Regulatory Authorities
  • Study Subject Insurance and Investigator Indemnity per local Regulations
  • Submission of Dossier and close tracking all steps of documents processing
  • Obtaining initial Regulatory Approval in the minimal possible time — 8 weeks after submission of trial documents
  • Obtaining Import/Export licenses for study drug and non-drug supplies

The result — quick start up of the study: cost efficiency for Sponsor.

  • Timely submission of all study specific documents to EC and / or RAs (per local regulations and GCP requirements) during the study

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Clinical Trial Monitoring:

  • Site Selection and Qualification in accordance with Protocol and ICH GCP requirements
  • Site Initiation
  • Routine site Monitoring per Monitoring Plan and Sponsor Expectation to provide high Quality of data retrieved
  • Tracking of Query resolution process
  • Site management
  • Study logistics management
  • Study Close-out

The result — high quality of data.

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GCP Auditing, preparation for regulatory inspection, audits support:

We have close partnership with leading Russian auditing company ClinQuality.

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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.

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Medical Monitoring:

Our Medical Monitor works closely with the sponsor and each project group throughout the course of a study. PRUDENTAS' Medical Monitoring services connect all phases of clinical research. To ensure quality performance of clinical activities, PRUDENTAS' Medical Monitor provides:

  • Feasibility Assessment
  • Medical Monitoring and Liaison
  • Safety Management and Surveillance
  • Literature Evaluation (Competitor Analysis)
  • Medical Consultation
  • Therapeutic Area Training and Guidance
  • Project Team Therapeutic Leadership
  • Interface with Data Safety Monitoring Boards (DSMB)
  • SAE Reporting Assessment
  • Regulatory Evaluation of SAEs

Qualified and experienced in the clinical development process, our Medical Monitor collaborates closely with our Regulatory Manager, Investigators and the Clinical Project Team.

One of the most important functions of our Medical Monitor is safety surveillance and serious adverse event (SAE) management. 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.

Our Medical Monitor will ensure the adverse events are properly identified and thoroughly investigated, reported and tracked in accordance with ICH GCP, Sponsor and Local Regulatory requirements.

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Site Management:

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

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Management (subcontracting) of Russian Central Labs, Warehouse and Data management & Biostatistics providers:

We collaborate on a contractual basis with leading Laboratories and Warehouse in Moscow, which may be used as a Central Laboratory and Study Supplies Depot for our clinical trials. These vendors have up-to-date equipment, comprehensive SOPs, internal and external quality assessments and certificates, experienced in international clinical trials, may provide dedicated to specific study personnel. We have partnership cooperation with providers of EDC tools, Data Management and Biostatistics.

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