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SanaClis - Full Service Contract Research Organisation in Central and Eastern Europe

SanaClis is privately-owned CRO founded in Slovakia in 2000. The quality of our service is our main priority - we work on each study as if an audit or inspection should come tomorrow.

Operations in 14 European countries

  • Slovakia
  • Czech Republic
  • Germany
  • Austria
  • Poland
  • Hungary
  • Estonia
  • Latvia
  • Lithuania

Operations in non-European countries

  • Ukraine
  • Russia
  • Belarus
  • Georgia
  • Switzerland

SanaClis services

  • Clinical monitoring IMP and CTS management: Ukraine, Russia and Georgia
  • Customs clearance and brokerage: Ukraine, Russia and Georgia
  • Regulatory services
  • Site contracting and payments
  • Project management
  • Pharmacovigilance
  • Data management
  • Statistics and medical writing
  • Central laboratory and bioequivalence: Russia

Positive rating by reputable business rating agency Creditreform in 2012: "Establishing of business connection is safe"

Clinical monitoring services

  • Regulatory and clinical monitoring services for international clinical studies (Phase I-IV)
  • Professional staff (with FDA and EMEA inspections experience)
  • Experience in all therapeutic areas including rare indications 84% of CRAs with monitoring experience of more than two years
  • Recruitment target exceeded or met earlier in 97% of studies high-quality of services (no critical or major findings during audits and/or inspections)
  • Quality and safety net surrounding each CRA project managers for international clinical studies

Depot services in Ukraine, Russia and Georgia

Warehousing and Management of IP and CTS (ambient/cold/frozen)

  • Warehousing within the best practices of clinical trials logistics and conduct in compliance with GMP, GCP, GDP and local regulatory standards
  • Electronic SanaClis inventory management system with online sponsor access
  • Validated central monitoring system (temperature/humidity)
  • Security of IP at any time

Distribution IP and CTS

  • Own validated shippers for ambient/cold/frozen temperature-controlled shipments
  • Validated temperature loggers (ELPRO, Sensitech m/u)
  • Local labelling of study supplies, comparators, rescue medication Incineration IP and CTS
  • SanaClis was the first CRO with its own warehouse in Ukraine specialised in IMP management for international clinical studies (since 2001)
  • Warehouse area: 1,060 m² (Ukraine); 400 m² (Russia); 300 m² (Georgia)
  • SanaClis has done over 300 international clinical studies (Phase I-IV)
  • More than 40,000 shipments to sites (ambient, cold, frozen)
  • Successfully passed 45 GCP / GMP sponsor audits and 8 GCP/GMP inspections
  • Each office is ISO 9001 certified

CRO-pharma

Customs broker services

  • Advice on required documents and invoice preparation/harmonisation
  • Advice on best import strategy (permanent vs. temporary) to reduce the costs
  • Customs officer can open and check the shipment content only in the presence of our customs broker (trained also in GMP

Comparators and rescue medication sourcing

  • Wholesaler pharmaceutical licenses in Ukraine and Russia
  • Direct contracts with drug manufacturers or their authorised distributors in each county
  • Secure supply chain and best rates are ensured

Data management

Data management and biostatistics department provide high-quality services to support the clinical development of drugs and medicinal products through the use of powerful and efficient CDISC Certified and regulatory compliant EDC software suite and
services of professional biostatisticians.

Our team delivers top quality data on-time, within budget and helps to avoid delays in the clinical research process. Our expert statisticians work closely with the DM team to meet the needs and objectives of each specific project, providing every time a customised service.

  • Database design, eCRF and edit checks setup and validation
  • MedDRA/WHODRUG auto-encoding and manual coding
  • Query handling/query workflow and data cleaning
  • Double data entry for paper based CRF
  • Central/local laboratories data support/reconciliation
  • EDC WebPRO access for patients
  • Full service in case of EDC including helpdesk
  • Blind/open randomisation
  • Customised data listings and reports generation
  • Data export/data transfer (CDISC standards/datasets for SAS/SPSS)

Statistics

  • Statistical analysis plan
  • Statistical programming
  • Statistical study report
  • Adaptive designs / Interim analysis
  • Meta-analyses (efficacy, safety)

Medical writing

  • CRF design
  • Clinical study report
  • CTD support
  • Informed consent
  • Study protocol
  • SAE narratives

Central laboratory NACPP

  • For samples delivered from any location in Russia
  • Research spectrum: more than 2,000 types of laboratory parameters in all areas of clinical medicine
  • 24/7 service, express diagnostics (CITO)
  • Capacity of bio fluids analyses is 10,000 - 11,000 samples per day
  • Team of highly qualified laboratory staff advanced equipment and test systems
  • Compliance with international and national standards of management and laboratory services
  • GOST, GMP, GLP
  • Unique laboratory information system (LIMS)
  • Integration into the information system of our partners
  • Remote logging, results available online bioequivalence studies

CRO

Clinical trial laboratory

  • Pharmacokinetic analysis of novel drugs at different phases of clinical trials including Phase I
  • Bioequivalence studies of medicinal products in compliance with international standards
  • Investigation of pharmacokinetic characteristics of registered medicinal products
  • Therapeutic drug monitoring
  • Quality control of medicinal products registered in Russian Federation
  • Detection of fake drugs (independent pharmacological expertise)


Contact details:
SanaClis s.r.o. (Headquarters)

Stare Grunty 61 841 04
Bratislava
Slovakia
Phone: +421 917 820 310
Email: info@sanaclis.eu
Website: www.sanaclis.eu