Checklist for choosing CROs in Asia Pacific

By Kirsty Barnes

- Last updated on GMT

Related tags Asia pacific Clinical trial

As clinical trial activity in the Asia Pacific region continues to
boom, Novotech, the largest Australian owned contract research
organisation (CRO) has presented a checklist to help pharma firms
minimise risk when choosing a partner.

"When choosing a CRO to work with in the region, speed and cost savings are not enough,"​ Novotech CEO Alek Safarian told delegates at the Drug Industry Association (DIA) annual conference in the US last week.

"All eyes are currently on the Australian and Asian region for drug trials and research and the checklist will help guide international CROs and biopharma companies to make the right choice to suit their needs."

The most important decider, once a fit is established, is a site audit of the corporate headquarters and associated facilities to ensure they are at the standards required, said Safarian.

"Decision makers really need to see for themselves that the CRO is offering exactly what they are promising, in order to ensure quality and smooth operational progress."

Other attributes a CRO must have include international expertise, a track record of trials with US and other pharma and biotech firms, either directly or through international trials, as well as an unparalleled knowledge of local regulatory procedures, said Safarian.

"Ideally they are also referrals from other trusted sources."

The clinical trials industry in the Asia Pacific region has exploded over the last few years - particularly India who is now holding the lion's share of the world's contract research business - as drug companies have realised the potential for outsourcing trials to this region for faster trial turnaround and major cost savings.

With the average cost per patient of running a US-based clinical trial being $5404 (€4244) for Phase I, $6538 for Phase II and $7635 for Phase III, pharma companies are flocking towards low-cost destinations such as India in a bid to cut direct clinical trial costs.

There are, however, ongoing concerns surrounding the regulation of trials carried out in developing nations such as India.

Although the 2005 amendment to the schedule Y of the Drugs & Cosmetics Act has been moving India towards the acceptance of International Conference on Harmonisation (ICH) guidelines for clinical research, at present, Indian regulatory authorities are not experienced enough and do not have the infrastructure set up to adequately cope with this clinical trial explosion and monitor the situation tightly.

Furthermore, recent media reports have surfaced suggesting that the clinical trials being conducted in India often target poor, illiterate and sometimes mentally incapacitated patients, many who are unaware they are even taking part in clinical trials that could be detrimental to their health.

It has been reported that even when consent forms are signed by participants, many of them were signed without the patients really knowing or understanding what they were doing.

However, Australia may hold the answer - having been ranked the number one location to conduct drug clinical trials in a recent international benchmarking study due to the low average costs of conducting studies, the large number of recognised trial sites and high percentage of trials being completed on time.

The Economist Intelligence Unit (EIU) study ranked Australia against six countries - US, UK, Germany, Japan, Singapore and India.

Other studies have also found that clinical research costs may be as much as 30 per cent lower in Australia than in the US and Europe and in addition, Australian regulatory procedures often enable a trial to begin in as little as 2-3 months from the initiation of the approval process - comparing favourably to slower timelines in major Western countries.

As a result, Australia can expect to look forward to a 15 per cent annual growth in trials carried out on its shores, fuelled by business from large pharma firms.

Novotech, which has recently been bestowed with the 2006 Frost & Sullivan Asia Pacific Healthcare Best Practice Award, has already gained a strong foothold in the Australian market and is tipped to greatly benefit from the expected boom, according to Frost & Sullivan Program Manager Shruti Dwivedi.

The firm recently came out on top against its competitors after being evaluated on key criteria including research capabilities, breadth and depth of services, geographical coverage, and alliances/partnerships that would enhance capabilities and the growth strategies adopted in pursuit of corporate objectives, said Dwivedi.

"Novotech offers a broad spectrum of services in Australia and New Zealand, catered by a strong research team, experienced in diverse therapeutic fields. It has also formed a subsidiary in UK as well as external partnerships in North America and other regions to widen its geographical reach."

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