Clinical Trials Services
Cefea facility based in Warsaw provides clinical trial services with cooperation with Sponsors and CRO companies.
We provide a fully comprehensive logistics process service including receipt of comparable and associated products, manufacturing activities, consolidation of samples for despatch with the documentation, distribution to centres conducting clinical trials, management of returns and disposal of returns.
Cefea offers services for Clinical Trials:
• Import of IMP
Audits of plants/sites manufacturing investigational medicinal products ( IMPs) in order to assure that IMPs are manufactured/distributed in accordance with GMP/GDP rules
QP Declaration
Batch certification of imported IMP
Custom clearance in cooperation with Custom Agencies
Site of physical importation
We deal with all aspects related to organization of analytical batch release studies performed in the European Union in contract laboratories audited by Cefea
• Clinical Packaging and Labelling also in Cold Chain
Secondary Packaging Solutions
Labelling boxes, vials, bottles
Ambient & Cold chain fully controlled temp. packaging
• Clinical Label Design and Print
We are able to create patient kits that can be suitable for any patient in any region
Label/Leaflet text translation co-ordination
Variable text printing
Multi-language booklet labels
Leaflet printing
Boxes printing
• Release and certification of clinical trials
We have QPs and an experienced support team who are able to assist clients in the release of IMPs for use in Clinical Trials.
According to Clinical Trial Directive 2001/20/EC and Annex 13 to the European GMP Guide, all Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a Clinical Trial.
• Storage of medicines for clinical trials, also in in Cold Chain conditions, i.e. temperatures from +2°C to +8°C
Validated Temperature monitoring devices
Controlled ambient storage (15 to 25 C)
Controlled Cold Chain storage (2 to 8 C)
Strict supervision of stock
• Purchase of comparators from any part of Europe
We take time to understand the scope and requirements of your project in order to provide:
The best possible price
Optimal remaining shelf life
Regulatory compliant product from EU
• Clinical Distribution
Validated Temperature monitoring devices
Optimized shipment route selection
Monitoring the status of shipments via the Internet
Delivery 7 days a week, 24 hours a day
International shipments can be sent by selected couriers
• Returns and Destruction
To close out our activities in support of a study, Cefea provides facilities for investigational drug returns, accountability and destruction.
Acknowledgement of returns and destruction of materials
Professional service by QP
We’re committed to quality and strive for the highest levels of quality every day.
