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Clinical Trials (Phases I-IV)

Services:

»  Regulatory Affairs_______»  Project Management
»  Site Management_______»  Monitoring
»  SAE Report____________»  Data Management
»  Investigator Meeting


Our client-focused approach, extensive experience, highly trained personnel and the expertise of our investigators guarantee fast recruitment and exceptional quality of services provided.

  • We operate under current ICH and CFR 21 GCPs.
  • Our project managers and CRAs are licensed physicians.
  • All our staff are fluent in English, and many are fluent in other languages as well.
  • Over the past 17 years, EVIDENCE has recruited
    more than 28,000 patients.
  • We provide our sites with clinical and technical support
    24 hours a day, 365 days a year.


Regulatory Affairs

Our qualified and dedicated personnel has 17 years' experience working with local regulatory authorities, which allows us to obtain study approvals in the shortest time possible.

  • Preparation of submission package
  • Fast study approvals
  • Smooth import/export approvals
  • Local insurance policies for patients
  • Drug labeling


Project Management

EVIDENCE has extensive experience in clinical project management. Our business approach is to treat our clients' needs as our own. The Project Leader serves as the client's primary point of contact and has direct responsibility for all aspects of the project. This direct line of communication ensures full transparency, accountability, efficiency and responsiveness.

  • Management of study teams
  • Management of investigator grants
  • Weekly status reports
  • Study-specific CRA training
  • Study team building
  • Communication with sponsor
  • Study timeline review and planning
  • Medical writing


Site Management

EVIDENCE's extensive experience in conducting clinical trials, highly trained CRAs, thorough knowledge of local regulations, modern equipment and the latest data transmission technology guarantee effective management of investigator sites.

  • Obtaining local ECs/IRBs approvals
  • Regulatory document collection, clearance and update
  • Study progress monitoring at site
  • Telephone contact with sites
  • Mass mailing/Newsletters


Monitoring

EVIDENCE's longstanding dedication to quality is solidly founded not just on its principles and standards, but also on the people it works with. As the first CRO to conduct clinical research in Russia and Eastern Europe, EVIDENCE has consistently sought out the best specialists to partner with. All our monitors are licensed MDs, experienced in clinical trials, GCP-trained and fluent in English.

  • Site selection, qualification and initiation
  • On-site monitoring
  • In-house CRF review
  • Source Data Verification
  • Query resolution
  • Site closeout


SAE Reporting

EVIDENCE conducts clinical trials in full compliance with international and local regulations, in strict adherence to ethical and scientific standards in current ICH and CFR 21 GCPs. We process Serious Adverse Events (SAEs) in accordance with international and local regulations while respecting client requirements on process flow and documentation format.

  • Medical monitor (physician) on call 24/7
  • Reports to sponsor within 24 hours
  • SAE follow-up
  • Search for non-reported SAEs in source documents
  • SAE notification of regulatory authorities, investigators and local ECs/IRBs


Data Management

EVIDENCE complies with current ICH and 11 CFR 21 GCPs and guarantees the highest quality of data handling. EVIDENCE has developed data quality control and back-up systems, as well as a disaster recovery plan. Our data management professionals provide a full range of data management services needed to successfully conduct a clinical study.

  • Database development and maintenance
  • Generating queries and reports
  • Generating schedules and deadlines
  • Randomization
  • Remote data entry
  • Double data entry with third-person verification


Investigator Meeting

EVIDENCE has extensive experience in organizing investigator meetings. We understand the need for proper planning and believe that investigator meetings provide an excellent opportunity for clinical team members to meet and establish working relationships with sites.

  • Assisting client in developing agenda and presentations
  • Preparation of presentation materials (e.g. overheads, slides, PowerPoint presentations, etc.)
  • Preparation of meeting materials for attendees (e.g. binders, printed materials, etc.)
  • Study-specific investigator training
  • Meeting venues
  • Meeting management
  • Translation and interpreting
  • Travel arrangements, accommodation and leisure