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SanaClis

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SanaClis

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.

Operations in 14 European countries

SanaClis operates in a wide range of countries in Europe, including:

•   Slovakia

•   Czech Republic

•   Germany

•   Austria

•   Poland

•   Hungary

•   Estonia

•   Latvia

•   Lithuania

Operations in non-European countries

SanaClis also operates in non-European countries, including:

•   Ukraine

•   Russia

•   Belarus

•   Georgia

•   Switzerland

SanaClis services

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

Clinical monitoring services

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

Depot services in Ukraine, Russia and Georgia

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: 

•   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

CRO-pharma

Customs broker services

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)

Comparators and rescue medication sourcing

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

Data management

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)

Statistics

SanaClis’ statistics services include:

•   Statistical analysis plan

•   Statistical programming

•   Statistical study report

•   Adaptive designs / Interim analysis

•   Meta-analyses (efficacy and safety)

Medical writing

The firm’s medical writing services, include:

•   CRF design

•   Clinical study report

•   CTD support

•   Informed consent

•   Study protocol

•   SAE narratives

National Association of Claims Processing Professionals (NACPP) approved central laboratory 

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

CRO

Clinical trial laboratory

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)

Contact

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

Bioequivalence Studies in Russia

See our bioequivalence studies in Russia here.

Clinical trial laboratoryPharmacokinetic analysis of novel drugs at different phases of clinical trials including phase IBioequivalence studies of medicinal products in compliance with international standardsInvestigation of new pharmacokinetic characteristics of registered medicinal productsTherapeutic drug monitoringQuality control of medicinal products registered in Russian FederationDetection of fake drugs (independent pharmacological expertise)

Central Laboratory in Russia

See details of our central laboratory in Russia here.

For samples delivered from any location in RussiaResearch spectrum: more than 2,000 types of laboratory parameters in all areas of clinical medicine24/7 service, modern methods of express diagnostics (CITO)Capacity of bio fluids analyses is 10,000 - 11,000 samples per dayTeam of highly qualified laboratory staffAdvanced equipment and test systemsCompliance with international and national standards of…

Clinical Monitoring Services

SanaClis clinical operations team provides high-quality clinical trial management and monitoring services keeping quality and timelines as a top priority. Through the years SanaClis performed clinical trials in almost all therapeutic areas, including rare indications.

The most outstanding character is that in addition to the high-quality which has been confirmed by numerous audits, SanaClis team has exceeded or met earlier recruitment targets in 97% of studies.SanaClis clinical operations teamProfessional staff (with FDA and EMEA inspections experience)84% of CRAs with monitoring experience of more than 2 yearsProject Managers for international clinical…

Comparators and Rescue Medication Sourcing

SanaClis s.r.o. through the local affiliates in Ukraine (SanaClis TOV) and in Russia (SanaCrus) is providing the comparator drugs and rescue medication needed for clinical trials.

SanaClis is working with drug manufacturers or their authorised distributors in each county to ensure the secure supply chain and best rates.Both SanaClis TOV and SanaCrus have wholesaler pharmaceutical licenses.

Customs Services

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) and SanaCrus (in Russia) can be your "importer of record" and obtain:Import license for IP and clinical trial supplies/equipmentExport licenseCertifications by local authorities (if applicable for the equipment or devices, f.e. metrology certification)Customs broker servicesAdvice on required documents and invoice preparation/harmonisationAdvice on best import strategy (permanent vs. temporary) to reduce the costsCustoms…

Data Management

SanaClis data management 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 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 validationMedDRA/WHODRUG auto-encoding and manual…

Distribution of IP and CTS in Ukraine, Russia and Georgia

See details of SanaClis distribution of IP and CTS in Ukraine, Russia and Georgia here.

ExperienceMore than 40,000 shipments to sites (2001-2013; ambient, cold, frozen, toxic)More than 300 international clinical studies (Phase I-IV)DistributionOwn validated shippers for ambient / cold temperature-controlled shipments to sitesValidated temperature loggers (ELPRO, Sensitech m/u)Own couriers trained in GDPLocal purchase and labelling of study supplies, comparators, rescue medicationIncineration IP & CTSArchivingUp-to-date electronic stock and data management 

IP and CTS Depot Services in Ukraine, Russia and Georgia

SanaClis was historically the first CRO with the warehouse in Ukraine specialized on IMP management for international clinical studies (since 2001).

Even today, we are the only CRO in Ukraine with its own warehouse and up-to-date technologies (ELPRO central monitoring system, electronic inventory management system, CCTV).Our depots in Ukraine (1060 m²), Russia (400 m²) and Georgia (300 m²) have implemented best practices of clinical trials logistics and conduct in compliance with GMP, GCP, GDP and local…

Medical Writing

See details of our medical writing here.

CRF designClinical study reportCTD supportInformed consentStudy protocolSAE narratives

Regulatory Services

See details of our regulatory services here.

Regulatory authority and ethics committee submissionsPreparation of complete packages for the regulatory authorities and ethics committeesAdvice to sponsor on local requirements for submission documentsSanaClis expertise of study documents provided by sponsor and/or any third parties involvedTranslation of documents by certified staff/agencyApplications to the national regulatory authorities and ethics committeesSubmission to RA & ECs/advise on review…

Site Contracting and Payments

See details of SanaClis site contracting and payments here.

Mediation of contracts between the sponsor and the site/investigatorSigning the contracts on behalf of the sponsorAdministration and processing of site payments (in Euro or in local currency)Knowledge of local requirements and authorised persons at different hospitals

Statistics

See details of our statistics here.

Statistical analysis planStatistical programmingStatistical study reportAdaptive designs/interim analysisMeta-analyses (efficacy, safety)
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