SanaClis

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Global Full-Service CRO with an Integrated Clinical Supply Chain

SanaClis provides a full range of CRO services, supply chain, logistics, and sourcing skills for clinical trial sponsors.

 

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Mlynské luhy 5400/29,
821 05 Bratislava,
Slovakia
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SanaClis is a full-service global contract research organisation (CRO) with an extensive set of in-house clinical supply chain, logistics, and sourcing skills. We offer a comprehensive range of end-to-end solutions for clinical trials worldwide throughout the entire lifecycle of the study. By adapting to sponsors’ needs, we can work as both a full and functional service provider.

Founded in 2000, the company has successfully conducted clinical trial projects for sponsors of various sizes, ranging from virtual biotech companies to top-rated pharmaceutical firms. All projects given to our care are delivered before or on time and within budget, ensuring quality, expertise and responsiveness.

Contract research organisation and supply chain services

SanaClis provides CRO and clinical supply chain services across all therapeutic areas and geographic locations, including Europe, the UK, Asia, and the US. Our clinical experience in Central and Eastern European (CEE) countries also offers several advantages, ranging from high patient enrolment rates to high-quality data.

We have a global network of privately owned storage and distribution depots that are certified according to good manufacturing practice (GMP) and good distribution practice (GDP) regulations. These facilities offer extensive storage capacities at all required temperature conditions, providing all the clinical supply services needed throughout the cold chain lifecycle of an investigational medicinal product (IMP).

SanaClis serves all therapeutic areas and geographic locations, including Europe, the UK, Asia, and the US.
We offer an extensive range of in-house clinical supply chain, logistics, and sourcing skills.
Our teams can provide a full range of services for CRO clients, covering all points of the clinical trial process.

Full support throughout the entire clinical trial process

SanaClis offers a full range of services for CRO clients, covering all points of the clinical trial process. Our capabilities include project management, regulatory affairs, clinical monitoring, data management and biostatistics, medical writing, and consultancy for pharmacovigilance and medical affairs.

Our teams can help prepare complete packages for the Regulatory Authorities and Ethics Committees, as well as advise sponsors on specific local requirements for submission documents. We can also translate documents in accordance with local requirements and ensure compliance with international and local reporting customs.

For Phase I-IV clinical trials, SanaClis can assist with feasibility processes and site selection; pre-study site evaluation visits; and investigational site setups, as well as analyse competitive studies and site workloads.

In-house supply chain services for clinical trials

SanaClis provides qualified person (QP) services for the EU’s QP release scheme and support for customs brokerage, warehousing, and distribution at all required temperature conditions. Our dedicated in-house QP team can guarantee that your IMP meets all relevant GMP standards, requirements, and quality.

We offer a comprehensive, cost-effective range of secondary packaging and labelling solutions for IMPs, which are certified according to GMP standards. Our customs clearance and brokerage consultants can resolve logistical challenges to ensure the efficient import and export of your product.

SanaClis’ in-house sourcing team can mitigate delays in sourcing clinical trial materials, providing your study with all required medication and ancillaries. We also have a proprietary inventory system for IMP product accountability, which can track the entire cold chain process.

All our facilities both in and outside the EU follow best practices of clinical trial logistics in compliance with good clinical practice (GCP), GDP and GMP standards. We have delivered more than 125,000 shipments to sites, including ambient, cold and frozen goods, via our in-house clinical supply chain over the past 20 years.

Focus on quality, timelines and cost

SanaClis has experience in successfully delivering studies for various-sized sponsors, from virtual biotechs to top ten pharma companies, across all therapeutic areas and indications.

We are a trusted partner to eight of the top ten pharma companies and have the flexibility and capacity to be both a full-service provider and/or a functional service provider, catering to all customers’ unique requirements, irrespective of size.

SanaClis remains your reliable partner, striving to ensure clinical excellence and superior quality, while achieving cost efficiencies and unwavering reliability that is applied to any clinical project within our care.

White Papers

Press Releases

  • SanaClis Breaking Barriers on the Court

    SanaClis is proud to announce that we are supporting Paralympic tennis team player Tomas Masaryk. As a company committed to making a positive impact on society, we are thrilled to support an athlete who embodies the values of determination, resilience and excellence.

  • SanaClis Launches a Flagship US Clinical Supply Chain Depot in Ventura, CA

    SanaClis, a leading global clinical research organisation (CRO) and a prominent provider of clinical trial supply chain solutions, is excited to announce the launch of its state-of-the-art Clinical Trial Supply Chain Depot. This innovative facility aims to revolutionise the clinical trial industry by centralising and streamlining the entire supply chain process while offering a comprehensive range of services in one convenient location. By establishing this facility, SanaClis aims to enhance operational efficiency, eliminate delays and ensure seamless coordination across all stages of the clinical trial process.

  • Exciting Partnership Alert! SanaClis Joins Forces with the Croatian Ski Association

    We are thrilled to announce that SanaClis, a renowned leader in the pharmaceutical R&D industry, has become an esteemed partner of the Croatian Ski Association for a three-year period, which will run through the 2025-26 Olympic season. This marks a significant milestone for both organisations as they join hands to elevate Croatian ski racers to the peak of world skiing while nurturing the talents of the youth.

  • SanaClis Receives a Transport License for Controlled Substances

    As of March 2023, SanaClis further strengthens its’ capabilities by receiving a transport license for controlled substances. The license was granted by the Ministry of Health, on the basis of a technical and personnel inspection of the production site performed by the Slovak State Institute for Drug Control.

  • Interview with SanaClis CEO Alexander Fetkovsky

    SanaClis is a solution provider at the Marcus Evans Evolution Summit 2023 and the Evolution Europe Summit 2023. Ahead of the events, read here an interview with CEO Alexander Fetkovsky discussing the gaps in the clinical trial supply chain.

  • CTIS - Ready or Not, Here It Comes

    CTIS is the online system for the regulatory submission, authorisation and supervision of clinical trials in the EU and the European Economic Area. It is a single-entry point for all clinical trial data. As of 31 January next year, the use of the CTIS will be mandatory for all initial submissions and with just over two months to go ‘live’ the question lies: are you truly ready?

  • Supporting Global Clients in Conducting Clinical Programmes

    SanaClis, a full-service global CRO with an in-house clinical supply chain, has recently partnered with Protara Therapeutics, a biotechnology company committed to identifying and advancing transformative therapies for people with cancer and rare diseases.

  • SanaClis Has Been Awarded the Prestigious Silver Medal by EcoVadis

    SanaClis has been awarded the prestigious Silver Medal by EcoVadis, the world’s largest and most trusted independent provider of business sustainability ratings. The result of our seamless collaboration, teamwork and continuous commitment to sustainability is present in our achievement today!

  • SanaClis EU Depot Receives its Radiopharmaceuticals Licence

    As of July 2022, SanaClis further strengthened its supply chain capabilities, with the Slovak Republic Office of Public Health officially granting our flagship EU depot in Bratislava the license to store and distribute radiopharmaceutical products.

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Mlynské luhy 5400/29
821 05 Bratislava
Slovakia

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