Address: Stare Grunty 130, 841 04, Bratislava, Slovakia
Tel: +421 917 820 310
Fax: +421 264 28 76 25

SanaClis s.r.o.

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SanaClis is a full service European CRO that can support pharma and biotech companies in clinical development with the whole range of services under one roof. These include clinical monitoring, project management, regulatory support and advice, IMP/CTS logistics, customs brokerage, IT and data management, biostatistics, medical writing and translation, quality management and auditing.

SanaClis is the only European CRO with its own local depots for IMP and CTS in Eastern Europe. This advantage simplifies trial logistic and reduces trial costs for companies operating in Central and Eastern Europe.

Products and Services

The SanaClis mission is defined as quality of service: to work on each clinical study or other project as if the audit/inspection were scheduled for tomorrow. The company’s business ethics and principles focus on quality and timelines, transparency, financial fair dealing and client protection, including IP security, data protection, comprehensive insurance and professional liability.

SanaClis provides services in four key areas:

Regulatory

SanaClis can advise and assist with Regulatory Authority and Ethics Committee submissions, including preparation of complete packages for approval and translation of documents according to local requirements. It will act as liaison between sponsor and local RA/EC throughout the study, ensuring compliance with international and local reporting requirements and handling any follow-up submissions or notifications, Import/Export licenses and permits and local certifications where needed.

Clinical monitoring

SanaClis provides clinical monitoring and management services for phase I-IV clinical studies in eastern EU member states Slovakia, Czech Republic, Hungary, Latvia, Lithuania, Estonia and Poland, as well as Germany and Austria. It also provides clinical services in Switzerland, Belarus, Georgia, Ukraine and Russia. SanaClis can perform clinical monitoring in most therapeutic areas, with a pool of investigators experienced in cardiology, psychiatry, rheumatology, immunology, hepatology, oncology, orthopedics and many other disciplines.

IMP/CTS management

SanaClis is a specialist in the storage and distribution of Investigational Medicinal Products (IMP) and Clinical Trial Supplies (CTS), including import/export customs &brokerage agency, returns management and ensuring local destruction at study end. SanaClis can provide temperature-controlled storage of IMP & CTS, cool chain distribution and local purchase and labeling of comparators or rescue medication.

Data Management

SanaClis can provide a complete data management service from full-service setup and system operation to complete technology transfer and support over the complete trial lifecycle. Its EDC system is compliant with FDA and European regulations, including 21 CFR Part 11 and GMP 11. SanaClis is an active member of the CDISC organisation and its EDC system supports multi-language eCRFs, full integration of external data (graphics, CT assessments, X-rays, etc.), e-signatures, clickable anatomical images, concomitant medication documentation, online and PDF reports. The Interactive Web Response System (IWRS) supports open or double blind randomization, multiple patients groups, randomization based on block list or minimization algorithm and IMP accountability modules.

Other Services

SanaClis can also provide expertise and support in the following areas:

  • Biostatistics
  • Medical Writing
  • Quality management & auditing
  • IT Management & Security

Technologies

SanaClis has adopted proprietary technologies and capabilities to provide unique advantages for its clients. SanaClis Inventory Management System (SIMS) is a proprietary GxP compliant software system used to barcode incoming products and to keep track of all operations. The system has built-in data validation mechanisms and operational checks to ensure flawless operations. The system also features direct B2B links with client IxR systems of our clients for full data synchronization.

The Swiss-made ELPRO Central Monitoring System enables on-line access to depot IMP and CTS warehouse providing real time data such as storage temperature, via secure Intranet. This extremely reliable and regularly calibrated system is compliant with FDA, GxP and GAMP requirements.

History and Structure

SanaClis s.r.o. was founded in 2000 in Slovakia’s capital, Bratislava, and soon began operations in Ukraine, becoming the first company to open a warehouse there specifically for clinical trial supplies.

In 2006, Dr. Natalia Fetkovska acquired a majority shareholding SanaClis and became Senior Partner. Dr. Fetkovska has more than 20 years experience in managing clinical trials and supplies in Central & Eastern Europe and played a key role in establishing and expanding Quintiles operations in Central and Eastern Europe.

Under Dr. Fetkovska’s strategic planning and leadership, SanaClis has progressively expanded, opening clinical departments in Ukraine, Slovakia and the Czech Republic and joining the Exquisite Alliance network in 2008. This provides SanaClis with reach right the way across the EU and also North America, working in collaboration with fellow alliance members embracing the same standard operation procedures (SOPs).

The company established its Russian subsidiary SanaCrus in 2013 to conduct clinical operations in Russian Federation.

Standards and Compliance

SanaClis is fully compliant with local, FDA and EMEA GxP regulation and standards. Operations are governed by rigorous internal and Exquisite Alliance SOPs and quality standards.

The company is certified to ISO 9001, with full pharmaceutical and wholesaler licenses for its local depots, brokerage licenses and business rating certificates.

SanaClis works to constantly improve performance through its Quality Manual, training, internal audits and an in-house QA department that enforces:

  • Regular QC of all business processes and systems
  • Effective change control management
  • Use of internationally certified and validated technologies
  • Effective selection process of service providers

Contact

To learn more about SanaClis products and services and how they can assist your business, please contact the supplier directly.



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