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June 27, 2014

The Way Ahead: Simplify Clinical Trials

Posted by Manish Tandon (View Profile | View All Posts) at 4:28 AM

The pharmaceutical research and development (R&D) process has many complex layers. Most of these layers go beyond the drug development process itself. We are talking about logistics, the compliance process, and the distribution network. Caught up in this maze, pharmaceutical companies often end up focusing on these processes, instead of the job at hand: developing effective drugs to make people healthy.

From my conversations with industry insiders, I've come to realize that the immediate cause for concern is really - managing the clinical trials process. Clinical trials is the part of the drug development process that has, in recent years, been outsourced to a batch of enterprises (Clinical Research Organizations) that specialize in dealing with the complexities. There are so many facets of the trial that keeping the cost of the processes down to make the drug commercially viable has become a huge challenge.

It is evident that a clinical trial supply management (CTSM) solution, which streamlines the supply chain, is clearly the way forward. Our research points us towards the following attributes - essential for developing a successful CTSM solution:

  • Scalability: Big pharmaceutical companies will continue to develop blockbuster drugs and market them to a worldwide audience, while smaller biotech firms are researching and developing drugs that tackle less common ailments. Big companies might require hundreds of test runs, while smaller biotech companies need a handful of trials. Therefore, it is important to develop a solution that can scale up or down, according to the requirement
  • 'Join the dots': The CTSM solution needs to connect the various stakeholders involved in the clinical trials process
  • Stock accountability: One of the most important aspects of the multi-level clinical supply chain is taking account of unused or expired drugs. An enterprise must make sure that it gets the optimal amount of drugs to market so that it doesn't encounter the possibility of having a significant portion of the stock go rancid
  • Cloud-based: While the right CTSM solution can reduce inventory overages by a significant percentage, enterprises often fear that the total cost of ownership (TCO) will offset any inventory savings the solution might provide. The answer is a cloud-based solution, which takes care of everything from product development, packaging, and distribution to dispensing, inventory, return and destruction

A CTSM solution must 'turbo-charge' the process from end to end. Being turbo-charged doesn't simply mean having enough power to go faster; it means giving power to the right places along the supply chain in order to draw out and amplify efficiencies. Then and only then does the process become faster. A cloud-based CTSM solution can do just that. It can keep all aspects of the pharmaceutical industry nimble and ready to develop tomorrow's life-saving drugs.

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