Providing sophisticated and complex protocol management for supply chain logistics
Specialising in controlled temperature storage
- Controlled Ambient storage 15°C to 25°C
- Controlled Ambient drugs storage 15°C to 25°C
- Cold Room storage 2°C to 8°C
- Cold Room controlled drug storage 2°C to 8°C
- Frozen storage from -20°C to -80°C
- Cryogenic storage in LN2 -150°C to -192°C
- Re-labelling
- Secondary packaging
- Comparator sourcing
- Returns management
- IVRS management
- Reconciliation, destruction and recalls
- Experts in complex clinical trials supply chain logistic protocols.
- Providing services to customer within Australia, Asia Pacific, America and Europe
Purpose built for specialised drug logistics, biorepository and manufacturing operations including:
- Clinical Trial Logistics
- Controlled Drug Distribution and Returns
- Biobanking & Biorepository Services
- GMP Manufacturing
Our people are our difference
Cryosite boast a highly experienced and qualified team of scientists and clinical trials experts who are 100% dedicated to managing complex clinical trials, pharmaceutical, life science and biological protocol management and logistics.
Established in 2003
With more than 18 years’ experience in clinical trials logistics, Cryosite specialises in complex protocol management across a range for temperatures. Cryosite provide full audit reporting for large and medium sized national and international biopharmaceutical companies, and contract research organisations.
Clinical sample management
Cryosite offer expertise in management of clinical samples (drugs, biologics, and medical ancillary devices) shipped from investigator sites for both interim or long-term secure storage, and coordinate shipment to testing laboratories when required.
Cryosite can assist with sourcing and supply of a range of Competior drugs upon request.
Cryosite ensure impeccable sample logs, storage, dispatch and distribution.
Pick-pack-dispatch
Cryosite is experienced in working with Interactive voice response systems (IVRS) and a range of other clinical trial management technologies. This ensures efficient dispatch, logging and step-by-step tracking of drugs and devices to investigator sites within Australia and overseas, minimising errors, damage and loss.
Cryosite works with clients’ preferred couriers to ensure safe, reliable and cost effective transport solution.
Returns and destruction
Full returns management and secure, segregated storage is provided until the end of each trial. Alternatively we can arrange for the controlled destruction of goods with Certificate of Destruction issued upon completion for your records.
Regulatory Quality Management System
Cryosite is experienced in working with regulatory and statutory organisations, and import license.
Cryosite holds accreditations with;
- Therapeutic Goods Administration (GMP)
- Department of Agriculture – DOA (Approved arrangement for imported goods)
- NSW Health (Scheduled Drugs) (GWP)
Import and clearance of shipments
Cryosite provides expert assistance with obtaining DOA and Department of Health import permits for a range of drugs, including Schedule 4 and Schedule 8 drugs.
Secure access and fully monitored facility
Cryosites’ facility and drug storage units are monitored by two independent, multi-zoned systems. Only authorised persons are permitted access to areas where drugs and devices are managed. Equipped with CCTV and motion detectors linked to external security, the facility has 24/7 surveillance and security.
Cryosite’s facility features include;
- Electronic controlled access, offering redundancy
- Security gates and patrols after hours and weekends
- 24/7 monitored CCTV facility
- Motion detector surveillance monitored by an external provider 24/7
Data security
Our IT systems are monitored internally and externally and backed up daily. We have the highest level of data encryption security across the entire company.
Power generator back-up
Cryosite’s facility has a back-up generator providing redundancy in power outages.
