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European Pharmaceutical Contractor

Find your Partner

Seeking to challenge the dominance of western organisations in Asia, a group of local CROs have formed an alliance, with the aim of providing sponsors with a fast, reliable and efficient service. Asia is gaining importance as a hub for multinational drug development, in particular clinical trials. North America and western Europe are already saturated with trials, and as the global economy recovers from the 2008 economic slowdown, their dependence on Asia for clinical trials is expected to deepen. The Asian pharmaceutical market is also growing and is expected to reach $270 billion within next 10 years if the current annual growth rate of 12.6 per cent is maintained.

Recently, a number of major pharmaceutical companies have established preferred service provider relationships with a handful of the top CROs. These CROs not only dominate the traditional markets in the west, but also within Asia. According to some reports, the five largest CROs hold a 55 per cent share of the total CRO market worldwide. The single point of contact and centralised management offered by these global organisations provide an attractive solution for busy executives of pharmaceutical companies, and the dominance of major CROs looks like to continue for some time.

Although Asia is gaining prominence as a region for drug development, the companies that currently benefit are western CROs. It is within this climate that a group of six local CROs, representing six Asian countries – China, India, Japan, Korea, Taiwan and Malaysia – have formed an alliance with the aim of providing services to sponsors wanting to carry out development work in Asia. “Why should my company work with such a rag-tag bunch of CROs instead of major CROs with proven records?” sponsors may ask, adding that “major CROs have working networks all over the world, including Asia.”

In the past the question was whether to include Asian sites in the study or not, but times have changed. However, it is seldom asked who can do the best job in this region. Trials are by nature complex to implement and even more so in an unfamiliar environment, compounded by language and cultural and differences. Furthermore Asia, just as with any other region, is not as homogenous as many sponsors would expect. Even major CROs may not be able to guarantee a successful trial outcome due to these challenges. Nevertheless, it is notable that sponsors from Korea and China choose to work with major CROs, in spite of high costs.

When sponsors decide to include sites away from their home base, the usual questions concerning regulatory considerations, including ethics reviews, the site and investigator selection process, rough investigator fees and patient recruitment are raised. These questions are asked as sponsors want timely, reliable quality and reasonably priced data from clinical trials. Answers to these questions will be the same whether sourced from a local or a major CRO. The more critical question is which of the two can better deliver trial results.

Some may view the CRO alliance as a rather incoherent group, even though the alliance consists of highly reliable and qualified local CROs. Although there is no comparison between the global reach of a major CRO and the alliance, there are many benefits to working with an alliance of CROs, which should be discussed in more depth.

Centralised Management Multinational

CROs have centralised management while an alliance does not. Centralised management is considered an important strength of major organisations; an alliance must reach a consensus to make any management decision perhaps after protracted discussions, while the decisionmaking process at a major CRO is far more straightforward. Major CROs manage studies from thousands of miles away via local affiliates. In regions where clinical studies are well established, long-distance management of projects may not be much of a problem because local affiliates are experienced and used to working with non-resident senior management. However, this may not work as well in Asia where conducting clinical trials has been established relatively recently, and the variation within the region is much wider than in North America or Europe. The US FDA and the EMA are the regulatory authorities in the US and Europe, but there is no such organisation in Asia. A centralised decision made thousands of miles away may not work as well in Asia as in North America or Europe. Flexible and regionalised management decisions would prove to be much more effective.

An experience in Korea illustrates this point. A reviewer from the Korean Food and Drug Administration noticed that the sample size in the statistics section of a protocol was different from the sample size cited elsewhere in the protocol. When the message was relayed to the major CRO, it took three months to hear back from the sponsor. Working with an alliance of local CROs would have been much quicker. Management decisions at major CROs can be slow and rigid while local CROs can be prompt and flexible.

Point of Contact

A single point of contact is considered to be another strength of the major CROs. Clients can click on the ‘contact us’ button of the homepage of any major CRO and imput their contact information. The eventual response may depend on who you are and how big your account is. A Korean biotech company recently complained how difficult it was having just one point of contact with the CRO. Every time the Korean business director contacted his representative, he had to wait a long time before getting a response. His counterpart in the CRO was a low level manager with little or no authority. However, the alliance works differently. For example, there are six CEOs in the group. If a complaint is filed with any one of the six, it will be immediately relayed with no delay.

Overheads

Every member CRO of the alliance is self-sustaining and has a strong local reputation. Outside of the alliance, each company has enough projects to sustain itself. The alliance does not have to maintain expensive headquarters. These overhead savings will be returned to the sponsors in the form of cost savings.

Experience

Large CROs may have more study experience overall than the local organisations. International CROs run their projects in Asia via their regional affiliates, who tend to be focused only on large pivotal studies. The study experience of the local CROs, however, is much broader, and includes small and large, early and late phase, pre- and post-approval, locally sponsored and internationally sponsored studies. Regional affiliates are mainly hired to monitor the trial, while the local CROs in the alliance can perform the entire spectrum of the clinical trial from protocol preparation and study start up activities to regulatory activities, site initiation visit (SIV), interim monitoring visit (IMV), close out visit (COV), data management, statistical analysis and clinical study report production. The experience of the staff within the alliance can be stronger than regional affiliates of major CROs. For example, in Korea, the big players hire experienced clinical research associates (CRAs) from local CROs, causing a lot of pain to these organisations. CRAs from local CROs work closely together, sharing work experience and new ideas, and generally helping each other out. This is a key strength of the alliance.

CRO Cost

With the exception of Japan, the cost of working with a local CRO is much lower than with affiliates of a major CRO. The investigator fee should be the same regardless of who runs the study. The local CRO should cost about half as much as the majors. Data management, statistical support and CSR at the local provider will cost as little as one-third of a major CRO.

Study Quality

Whether an alliance of CROs can match the quality provided by majors should be judged by auditing and due-diligence of the member companies. Many local CROs have worked with major CROs and pharmaceutical companies; as a result, there should not be any difference in study quality.

The alliance of CROs can be as effective, if not better, than the majors. Global reach aside, a well organised CRO alliance will be competitive in trial cost, effective in trial management, provide high quality studies and will be convenient for busy executives.

Contact Information

Potential sponsors may be still sceptical about the operational competence of the local CRO. There are no and it can be diffi cult to know who to contact. Any member of the alliance can be contacted. Sponsors can contract their local CRO or the organisation they feel most comfortable dealing with. Diverse points of contact are another the strength of the alliance. The initial contact, if you fi nd the contact comfortable, will remain with the project from the beginning to the end.

Quality of Staff

CROs belonging to the alliance all have experienced project management (PM) teams, and the sponsor can pick and choose which PM team they want to work with. A high level of staff quality can be achieved by adopting harmonised standard operating procedures (SOPs). Frequent auditing of member CROs will also achieve the uniformity of the quality.

Stability of the Organisation

All the member CROs are reputable local organisations, and the alliance holds monthly teleconference and biannual face to face meetings to ensure regular communication. It is clear that such an alliance of CROs can provide quality services in a timely manner and at a competitive price.

Conclusion

Asia, with the possible exception of Japan, has been on the receiving end of new drugs from the west, and this is not likely to end any time soon. Most new drug clinical trials in Asia originate from the west and thus are controlled by western organisations. However, there are now signs that Asian countries such as China and Korea – in addition to Japan – are entering the drug development field themselves. Asian product developers currently rely on western experts for global drug development. For example, Korean sponsors work with big-name CROs for their drug development outside Korea. This highlights a clear void in Asian drug development expertise, which the alliance is seeking to fill.

The governments of China, Japan and Korea are committed to making Asia a centre for pharmaceutical development (see Figure 1). If Asia is to become a true centre for drug development, the region must strengthen its own competence for clinical trials. The newly-formed alliance of local CROs aspires to become the best Asian experts in drug development, and is competitive not only in price but also in quality.


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Young Jack Lee is the founding chairman of the Asia CRO Alliance. He is a biostatistician by training, and holds a PhD in Statistics from Ohio State University. Jack worked for the US National Institute of Health between 1977 and 2001 as a Mathematical Statistician and Head of Statistics. He returned to Korea in 1999, and founded LSK Global Pharma Services, a full service Korean CRO, in 2000. Jack is now fully dedicated to his CRO business, and promoting Asian regional drug development. Jack also gives lectures on various topics in clinical trials and biostatistics.
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