Study medications and samples
The proper management of study medications and biological samples is a critical factor to the success of a clinical trial. Crossover employs highly trained and experienced professionals who can safely and efficiently handle various types of biosamples and study medications.
Study medications
All study medications and supplies are managed in compliance with the applicable regulatory requirements, sponsor’s instructions and according to written procedures for the appropriate handling and storage of investigational/comparator products and supplies.
The Crossover CRU, in cooperation with our partner healthcare institutions, can handle many aspects of study medication management, including:
- receipt
- labelling
- storage
- tracking
- inventory and accountability
- resupplies
- randomisation
- blinding
- release
- packaging
- shipment
- retrieval of unused product from subjects
- return of unused investigational product to the sponsor
- destruction of unused medication and empty packaging material if authorised by the sponsor
Our state-of–the-art storage facilities feature:
- restricted access
- clear separation from non-study medications and supplies
- appropriate environmental control monitoring
- temperature logs
- alarms and notifications of malfunctions
We also offer a stand-alone drug and supplies storage service.
Biosamples
Crossover facilities and processes are designed to handle the collection and laboratory analysis of many types of biological samples from trial subjects. The results from the analysis of these samples are often used to determine the efficacy and safety of the investigational product. The professional management of clinical trial samples can therefore be the key for the success of the whole study.
Crossover has access to modern laboratory facilities at its partner healthcare institutions. Biological samples obtained from clinical trial subjects can be immediately analysed, thus avoiding the need for shipment and the associated costs, delays and additional risks. Alternatively, the samples can be collected, safely stored and shipped to a central lab designated by the sponsor.
Our personnel are capable of managing clinical trials involving various aspects of biosample management, including:
- receiving
- labelling
- sample tracking
- analysis reporting
- storage
- packaging
- shipment
The laboratory facilities used by Crossover for sample processing and storage feature:
- restricted access
- an array of refrigerators and freezers for storage at the appropriate temperature
- clear separation from non-study samples
- appropriate environmental control monitoring
- temperature logs
- alarms and notifications of malfunctions
- back-up power supply
Crossover staff has experience with managing samples related to studies involving:
- genomics/genetics
- proteomics
- biomarker discovery and validation
- personalised medicine