Auckland Clinical Studies is taking strict measures to ensure the health and safety of patients, carers, participants and staff during the Coronavirus pandemic:
- Access controlled dispensary.
- Temperature controlled.
- Four Clinical Trial Pharmacists and a two-pharmacist checking process.
- On-site compounding or through local 3rd party provider – dilution and/or division of oral solutions/suspensions, dispensing of unit doses of bulk product, re-constitution of pre-weighed bulk drugs, re-constitution and dilution of sterile products, blinding, randomising, labelling, drug accountability.
- Sterile services: Positive pressure clean room environment, calibrated annually – grade A – grade C gradient, ESCO Labculture Plus Class II Laminar Safety Cabinet, Still air box. Environmental monitoring.
- Temperature controlled & alarm monitored storage: 4 fridges 2-8oC, 1 freezer -20oC.
- Blinding plans, Blinded dispensing, comparator supply, import permits and temperature monitored storage, retention samples, preparation of code break processes.
- Quarantined storage of Clinical Trial Supplies prior to local ethics approvals to enable faster trial start up.
- Retention sample storage capability.