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SanaClis
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SanaClis is a privately-owned contract research organisation (CRO) founded in Slovakia in 2000.
The quality of its service is its main priority, and the company works on each study as if an audit or inspection should come tomorrow.
SanaClis operates in a wide range of countries in Europe, including:
•  Slovakia
•  Czech Republic
•  Germany
•  Austria
•  Poland
•  Hungary
•  Estonia
•  Latvia
•  Lithuania
SanaClis also operates in non-European countries, including:
•  Ukraine
•  Russia
•  Belarus
•  Georgia
•  Switzerland
SanaClis was awarded a positive rating by reputable business rating agency Creditreform in 2012: “Establishing of business connection is safe”. Its services include:
•  Clinical monitoring investigational medicinal product (IMP) and clinical trial services (CTS) management in Ukraine, Russia and Georgia
•  Customs clearance and brokerage in Ukraine, Russia and Georgia
•  Regulatory services
•  Site contracting and payments
•  Project management
•  Pharmacovigilance (PV)
•  Data management
•  Statistics and medical writing
•  Central laboratory and bioequivalence in Russia
SanaClis provides regulatory and clinical monitoring services for international clinical studies (Phases I-IV). Its offerings include:
•  Professional staff with US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) inspections experience
•  Experience in all therapeutic areas including rare indications 84% of clinical research associates (CRA) 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
SanaClis’ depot services include warehousing and management of internet protocol (IP) and CTS (ambient/cold/frozen), which comprises:
•  Warehousing within the best practices of clinical trials logistics and conduct in compliance with good manufacturing practices (GMP), good clinical practice (GCP), good distribution practice (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
The company’s services related to the distribution of IP and CTS include:Â
•  Own validated shippers for ambient/cold/frozen temperature-controlled shipments
•  Validated temperature loggers such as ELPRO and Sensitech
•  Local labelling of study supplies, comparators, rescue medication Incineration IP and CTS
•  SanaClis was one of the first CROs with its own warehouse in Ukraine specialised in IMP management for international clinical studies (since 2001)
•  Its warehouse area spans 1,060m² in Ukraine, 400m² in Russia and 300m² in Georgia
•  SanaClis has performed more than 300 international clinical studies (Phases I-IV)
•  More than 40,000 shipments to sites (ambient, cold, frozen)
•  Successfully passed 45 GCP / GMP sponsor audits and eight GCP/GMP inspections
•  Each office is ISO: 9001 certified
SanaClis’ customs broker services include:
•  Advice on required documents and invoice preparation/harmonisation
•  Advice on best import strategy (permanent versus 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)
The company’s offerings for comparators and rescue medication sourcing include:
•  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
SanaClis’ data management (DM) and biostatistics department provides 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 electronic data capture (EDC) software suite and services of professional biostatisticians.
The company’s team delivers top-quality data on-time, within budget and helps to avoid delays in the clinical research process. Its expert statisticians work closely with the DM team to meet the needs and objectives of each specific project, providing every time with a customised service.
•  Database design, electrinic case report form (eCRF) and edit checks setup and validation
•  Medical Dictionary for Regulatory Activities (MedDRA) / WHODRUG auto-encoding and manual coding
•  Query handling / workflow and data cleaning
•  Double data entry for paper-based case report form (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 such as Clinical Data Interchange Standards Consortium (CDISC) standards / datasets for Statistical Analysis System (SAS) / Statistical Package for the Social Sciences (SPSS)
SanaClis’ statistics services include:
•  Statistical analysis plan
•  Statistical programming
•  Statistical study report
•  Adaptive designs / Interim analysis
•  Meta-analyses (efficacy and safety)
The firm’s medical writing services, include:
•  CRF design
•  Clinical study report
•  CTD support
•  Informed consent
•  Study protocol
•  SAE narratives
The company’s central laboratory features:
•  For samples delivered from any location in Russia
•  Research spectrum of 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
•  A team of highly qualified laboratory staff advanced equipment and test systems
•  Compliance with international and national standards of management and laboratory services
•  Meets GOST, GMP, GLP standards
•  Unique laboratory information system (LIMS)
•  Integrated into the information system of our partners
•  Remote logging results available online bioequivalence studies
The company’s clinical trial laboratory features:
•  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)
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