Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts

You are here

Services

IT Management

IT Management

At SanaClis we are considering IT Security and GxP Compliance of our computerized systems as a paramount objective. Our set of IT SOPs defines high standards of regulatory compliance throughout all the phases of systems life cycle. Validated status of our computerized systems is regularly verified by external audits from industry leading companies.

SanaClis Data Center features the following security measures:

Tags: 

Data Management

  • Full-service setup and system operation to complete technology transfer and support the complete lifecycle of the clinical trial
  • EDC system compliant with FDA and European regulations, in particular with 21 CFR Part 11 and GMP Annex 11.
  • SanaClis is an active member of the CDISC organisation
  • Database and data entry screens setup and validation
  • Single or Double Data Entry in case of paper CRF
  • Full service in case of EDC including helpdesk
  • Customized data listings and data report generation
Tags: 

Central Clinical Trial Laboratory in Russia

Central laboratory was founded in 2007 by leading Russian experts in the field of the laboratory testing.

Services provided:

  • Central laboratory (for samples delivered from any location in Russia)

Standards:

Tags: 

Quality Management

Quality and Safety net foresees following professionals to surround the CRAs toensure top quality of the provided services:

Tags: 

Site Contracting & Payments

  • Mediation of contracts between the Sponsor and the Site / Investigator
  • Signing the contracts on behalf of the Sponsor
  • Administration and Processing of site payments (in Euro or in local currency)
  • Knowledge of local requirements and authorized persons at different hospitals
Tags: 

Customs clearance & brokerage

Customs Services in Ukraine and Russia

SanaClis regulatory and customs officers inform the Sponsor in detail about all documents required by local authorities for importation of IMP and clinical trial supplies.

SanaClis in Ukraine / SanaCrus in Russia can be your “Importer of Record” and obtain:
Import License for IP and Clinical Trial Supplies / Equipment
Export License
Certifications by local authorities (if applicable for the equipment or devices)

Customs broker services

Tags: 

IMP & CTS Management

IMP & CTS Management (Depots in Ukraine, Georgia and Russia )

Sanaclis was the first CRO with the warehouse in Ukraine specialised on IMP management for international clinical studies (since 2001). Even today we are the only CRO in Ukraine with its own warehouse (1060 m²) and up-to-date technologies (ELPRO central monitoring system, CTMS, CCTV).

Our depots in Ukraine and Russia have implemented best practices of clinical trials logistics in compliance with GCP, GDP and GMP standards.

Experience:

Tags: 

Clinical Trial Monitoring

SanaClis provides clinical monitoring services for phase II-IV clinical studies in the following countries in Central & Eastern Europe:

EU countries:

  • Slovakia
  • Czech Republic
  • Austria
  • Bulgaria
  • Croatia
  • Estonia
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovenia

non-EU countries:

Tags: 

Regulatory

Regulatory Authority and Ethics Committee submissions

Tags: 

Clinical Trial Services

We are provding services in these areas:

  • Regulatory
  • Clinical Monitoring
  • IMP & CTS Management
  • Customs clearance & brokerage
  • Site Contracting & Payments
  • Project Management
  • Quality Management
  • Trainings
  • Central Laboratory Russia - incl. Bioequivalence Studies
  • Data Management
  • Statistics & Medical writing
Tags: