Most people in Southeast Asia (SEA) will shake their heads when asked about clinical trials, let alone clinical data management (CDM). If eClinical in North American and Western markets is a teenager, then here in SEA it has just slipped into the toddler stage. Instructing a child hence poses not so few challenges, yet opens door to promising possibilities as well.
On the bright side
People love new stuff. A primitive market means it readily welcomes and absorbs novel ideas. In this case, a shortage of awareness unveils countless possibilities for development. Considering the fact that most SEA countries (excluding the tiny mighty Singapore) are in the third tier in terms of CROs as well as the level of expertise and experience in clinical trials, the chances are high for eClinical to jump in the game. When you are a kid, you love exploring the world a lot more than when you enter your teens. And from parents’ point of view, a small child is easier to teach.
It is even more fascinating when this child is tech-savvy and responses quickly to technological innovations. Though much later exposed to technical advances, Southeast Asian pharmaceutical businesses in general and CROs in particular catch up remarkably fast with developed countries, say the U.S and Europe. It will come as no surprise to witness a boom in eClinical here in the upcoming decade.
From the standpoint of global pharmaceutical cooperations and CROs, on the other hand, this robust area promises a big hub for clinical trials in the near future. Merge and acquisition (M&A) in CRO market in recent years shows a trend away from original markets towards Asia. Most recently, Childtern has completed its purchase of a Japanese CRO whose activities spread from Japan and Korea to Southeast Asia. This act combined with the rapid expansion of other big corps into this young market signals an outbreak of clinical trials and consequently a boost of demand for CDM.
The challenges remain
An uneducated market is already an obstacle itself since it takes quite a while to raise awareness. What’s more, the background of these countries in CDM has yet to surpass entry level, meaning that in order for them to fully understand the concept before even writing down a deal, patience and a lot of investment have to be spent. The same goes for policies. While in well-developed markets, legal policies encourage clinical trials to make use of eClinical tools for increased efficiency, authorities in SEA countries are hardly aware of this solution.
Another impeding factor is change resistance. Forcing a shift from the accustomed methods such as paper forms and manually crafted spreadsheets is no piece of cake. Plus, CDM systems normally require intensive personnel training before utilized to make sure all regulations and standards are complied with, which may turn out to be a pain rather than a solution for conventional entities. Services offered by global enterprises are most of the time unaffordable for small and mid-sized studies in SEA.
With the available traditionally generated data of clinical trials already conducted, the question becomes how to make the most use of this legacy so that eClinical doesn’t result in redundancy. A good deal of data, time and money will be wasted if a thoughtful strategy is not given to taking advantage of these databases.
To sum up
Although a fresh market offers opportunities for growth without much competition, it requires careful attention and enormous effort. However, even big-sized markets like North America and Europe also had to drag through the muddy beginning period before flourishing like today. Southeast Asia is still a potential market for clinical trials and clinical data management in the foreseeable future, so make sure you keep up with the trend in this billion-dollar industry.