IMP & CTS Management

OPEN ELPRO MONITOR

IMP & CTS Management (Depots in EU (Slovakia), Ukraine, Georgia and Russia)

SanaClis was the very first CRO with the warehouse in Russia and Ukraine dedicated to IMP management for international clinical studies (since 2001). Even today we are the only CRO in Ukraine with warehouse (1060 m²) in its own premises and up-to-date technologies (ELPRO central monitoring system, SanaClis Inventory Monitoring System, CCTV, security 24/7).

All of our depots in EU and non-EU countries have implemented best practices of clinical trials logistics in compliance with GCP, GDP and GMP standards. SanaClis has done over 52 000 shipments to sites within 16 years (ambient, cold, frozen).

GMP/GCP audits

NO critical findings in 84 audits / inspections (72 GCP / GMP sponsor audits and 12 GMP / GCP inspections)

Services

  • storage of IMP & CTS (ambient, cold, frozen, toxic)
  • distribution using own insulated vehicles or ; qualified courier companies TNT, DHL, others) with couriers trained in GDP
  • validated packaging configurations for transportation (trust and well-known Credo Series TM products produced by PeliBioThermal, Va-Q-Teg and Laminar Medica qualified thermal packaging solutions)
  • certified temperature loggers for t-controlled ambient/ cold/frozen shipments (ELPRO loggers; Sensitech TT4)
  • sourcing (centralized and local purchasing)
  • storage and handling of narcotic drugs and psychotropic substances (in EU)
  • manufacturing service which covers labeling, secondary packaging, batch certification
  • local incineration, destruction certificates
  • archiving

Any shipment to the site can be done only upon prior agreement. Investigator confirms his/her presence at site and possibility to accept the shipment.

Warehouse in Slovakia:

Licensed and GDP certified depot located in Bratislava starting from 2016 as full warehousing services provider.

  • Total Warehouse Area: 300 m2 with potential increasing
  • 2 Cold Rooms
  • Manufacturing and NDPS Areas

Warehouse in Ukraine:

Warehouse is located between international Kiev airport and Kiev city.The warehouse obtained pharmaceutical license in 2012.

  • Total Usage Area: 2500 m2
  • Total Warehouse Area: 1060 m2
  • Strictly Limited Access: 801 m2
  • Cold Rooms / Cold Storage: 81 m2
  • Ambient storage: 720 m2

IT Technologies

SIMS – (SanaClis Inventory Management System), a GxP compliant software system. It is used to barcode incoming products and to keep track of all operations. The system has built-in data validation mechanisms/operational checks (such as storage conditions, expiry dates, etc.) to ensure correctness of data/operations. The system keeps all the records in a reliable database, protected by remote backups. The system also features direct B2B links with the IxR systems of our clients, updating the relevant data in automatic mode without human intervention/errors.

SIMS OA – live copy of company internal management system specially adapted for Client’s needs. SIMS OA provides distribution/stock/other reports with actual data at any convenient time for user. It is useful tool for tracking and monitoring.

ELPRO Central Monitoring System - Swiss made validated monitoring system for controlling temperature/humidity. Provides reliable, around-the-clock monitoring with local audio-visual alarm and automatic remote messaging. Data protection/security is ensured by industrial strength encryption removing any possibility of data alternation. This extremely reliable and regularly calibrated system is compliant with FDA, GxP and GAMP requirements.

SanaClis ElproLOG MONITOR-WebAccess allows to check and monitor storage temperature at warehouses in EU and UA in real time. No special tools or registration are required.