RAL completes clinical trial submissions to the regulatory authority and/or IRB/IEC as required.
Clinical Trial applications in New Zealand and Australia require a local sponsor, RAL can provide this service in New Zealand and through an affiliate in Australia.
RAL has an extensive knowledge of the key study sites within New Zealand and can quickly target the most suitable sites for a given study. RAL also enjoys well developed relationships with many of the key regional sites which include dedicated General Practice sites with access to a large and varied pool of potential participants. Feasibility reports can be produced within short time frames.
Our local presence provides advantages when assessing facilities, equipment, protocol logistics, and site-staff workloads along with the sites ability to effectively enroll participants in a given protocol. In addition to training site staff in protocol-specific procedures including laboratory, data transmission, drug dispensing and accountability RAL has an introductory GCP training course available as required, to aid site staff in complying with GCP.
The primary monitoring region is serviced to ensure that we continue to maintain the quality, longstanding business relationships developed with RAL sites. Complete on-site monitoring services include pre-study, initiation, routine monitoring and study closeout proceedings. RAL has experience with a number of the eCRF systems available. Monitoring has been completed as per the SOP of varying study sponsors however our flexibility means we can follow your SOPs, RAL SOPs, or a combination of both.