Frequently Asked Questions
Over the years the CPR has interacted with many Australian and overseas companies and fielded a lot of questions about our service. Here is a list of questions we often get asked by our clients.
- Why would international or Australian pharmaceutical companies place their trials in Australia when there are providers of the same services in the US?
- Why would we utilise the CPR to project manage studies when the clinical site can handle the whole package?
- Have you been audited by the FDA?
- Is there an issue in shipping samples to Australia?
Why would international or Australian pharmaceutical companies place their trials in Australia when there are providers of the same services in the US?
A recent report commissioned by the federal government rated Clinical Trials Services in Australia as being globally competitive for several reasons:
- The cost per subject of clinical trials is almost half the cost of the US.
- Only 10% of US clinical trials are completed on time whereas 80% are completed on time in Australia
- The quality of services is equivalent to services in US and Europe.
Why would we utilise the CPR to project manage studies when the clinical site can handle the whole package?
It is not mandatory that the CPR handle the project management of studies, we are able to provide a cost effective quality service in any of our core areas.
We have, however, found that companies with significant project pipelines often utilise the CPR for project management purposes for the following reasons:
We have, however, found that companies with significant project pipelines often utilise the CPR for project management purposes for the following reasons:
- Ease the logistical burden of managing several trials simultaneously
- Ability to place all non site specific activities with one provider (ie. protocol review, CRF design, initiation, monitoring, data management, bio-analysis, pharmacokinetic and statistical analysis and report writing with a single provider).
- Experienced staff to liaise with clinical site on the sponsors behalf
- Having a nominated single point of contact for all trial related issues
- Perceived reduction in bias in the eyes of regulatory authorities
Have you been audited by the FDA?
While the CPR has not been audited by the FDA we have had several reports from clinical trials submitted as part of larger submissions that have been FDA-reviewed. Our senior clinical and bio-analytical staff have been intimately involved in FDA audits with previous employers which were successfully completed without any Section 483 being issued. The CPR has also been audited several times by large pharma auditors.
Is there an issue in shipping samples to Australia?
The CPR regularly has samples shipped from international sites for bio-analysis. The CPRs preferred supplier is World Courier, which has an excellent reputation for delivering samples internationally under appropriate storage conditions.
Although there is a cost for shipment we find that the competitive pricing compared to US and European bioanalytical facilities outweighs the cost.
Although there is a cost for shipment we find that the competitive pricing compared to US and European bioanalytical facilities outweighs the cost.