SanaClis

• 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 or inspections)
• Quality and safety net surrounding each clinical research associate (CRA)
• Project managers for international clinical studies
• Depot services in Ukraine, Russia and Georgia

Warehousing and management of investigational products and clinical trial supplies

Warehousing services are provided within the best practices of clinical trials logistics and comply with GMP, GCP, GDP and local regulatory standards.

In addition, we offer an electronic SanaClis inventory management system with online sponsor access, validated central monitoring system (temperature / humidity), and security of investigational products (IP) at any time.

Distribution of IP and CTS for pharmaceutical applications

SanaClis has its own validated shippers for ambient / cold / frozen temperature-controlled shipments and temperature loggers (ELPRO, Sensitech m/u).

The company also has validated packaging configurations (Va-Q-Tec, Laminar Medica, Credo), local labelling of study supplies, comparators and rescue medication.

Incineration IP and CTS

SanaClis was the first contract research organisation (CRO) with its own warehouse in Ukraine specialised in IMP management for international clinical studies since 2001.

The company’s advantages include:

• Warehouse areas of 1,060m² in Ukraine, 400m² in Russia, 300m² in Georgia
• SanaClis has performed more than 300 international clinical studies (Phase I-IV)
• More than 40,000 shipments to sites, including ambient, cold and frozen
• Successfully passed 47 GCP / GMP sponsor audits and eight GCP / GMP inspections
• Each office is ISO:9001 certified

Customs broker services for medicinal products

SanaClis can be an importer of record and obtain:

• Import license for IP and clinical trial supplies / equipment
• Export license
• Certifications by local authorities if applicable for the equipment or devices
• Customs broker services
• Advice on required documents and invoice preparation/harmonisation
• Advice on best import strategy (permanent vs temporary) to reduce costs
• Customs officer can open and check shipment content only in the presence of our customs broker trained in GMP and GDP

Medication sourcing

We offer wholesaler pharmaceutical licenses in Ukraine and Russia, direct contracts with drug manufacturers or their authorised distributors in each country, as well as ensure secure supply chains and best rates.

Data management solutions

SanaClis’s data management and biostatistics department provides high-quality services to support clinical development of drugs and medicinal products through the use of powerful and efficient CDISC-certified, regulatory compliant electronic data capture (EDC) software suite, as well as services from biostatisticians.

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

Services include:

• Database design, electronic case report form (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
• Full service in case of EDC including helpdesk
• Blind / open randomisation
• Customised data listings and data report generation
• Data import / export (PROC CDISC / datasets for SAS / SPSS)

Statistical analysis, programming and reports for medicinal products

Statistics services include:

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

Medical writing services

Medical writing services include:

• CRF design
• Clinical study report
• Common technical document (CTD) support
• Informed consent
• Study protocol
• Serious adverse event (SAE) narratives

Comprehensive pharma developmental laboratories

SanaClis’s central laboratory in Russia provides a comprehensive range of services for pharmaceutical development.

From this facility, samples can be delivered from any location in Russia, with a research spectrum of more than 2,000 types of laboratory parameters across all areas of clinical medicine.

Round-the-clock services are provided, with express diagnostics (CITO) and a 10,000-11,000 daily capacity of bio fluid samples for analysis.

Our team of highly qualified laboratory staff use advanced equipment and test systems, ensuring compliance with international and national standards of management and laboratory services such as GOST, GMP, GLP.

We have a unique laboratory information system (LIMS) and offer integration into the information system of our partners. Remote logging and results are available online.

Bioequivalence studies

In our clinical trial laboratory, we provide:

• 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 the Russian Federation
• Detection of fake drugs through independent pharmacological expertise