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Transcript:
Welcome to the PharmaVOICE Webcast Network and this episode of the industry vision. I’m Taren Grom, Editor of PharmaVOICE. Today, we’d like to welcome Srivatsan, head of Life Sciences North America and Kaushik Bhaumik, Global Practice Leader Consulting and BPO for Cognizant.
Srivatsan: Thank you. We’re glad to be here today.
Taren: Can you please discuss the strategies you believe need to be implemented to transform the drug development process.
Srivatsan: Life Sciences clinical operations face many challenges today. They need to be more adaptable and flexible. Operations teams are required to scale up dramatically to accommodate the increase in study volumes. There are new support models which need to evolve to help global teams as they execute more trials internationally. The groups are constantly challenged in the ability to deploy the right resource to the right strategic area of operations. And finally, this constant pressure to keep costs low.
So what are clinical operations doing today? They're transforming themselves by developing process standards that can be consistently deployed across all their clinical trials. They're deploying global platforms and information infrastructure which can better support their teams around the globe. There is an increased adoption of information standards, like CDISC, to facilitate the exchange of information in a consistent manner across all clinical trial groups. They're constantly assessing all the processes that are being executed in identifying what's core to them and what are not and deciding on innovative and creative sourcing strategies.
So if we were to summarize, there are three things which are important – people and process, the information infrastructure to support them, and the innovative mechanisms to source the work to be done.
Taren: That’s great. Those are three significant shifts. How will this transformation impact the sponsors organizational structure?
Srivatsan: The sponsors organization structures look at different components. The first component they look at are their people. Clinical operations will assess their people to make sure that they're deployed in the most strategic areas of their operations. They’ll assess core, which is important to them, and non-core functions and make sure that they deploy the right people towards their strategic efforts.
Next, they look at their process. They establish standards to execute each of the clinical operations process, define best practices such that they can enable to diverse organizations, internal sponsor organizations, and outsource organizations to deliver consistent output.
Finally, they look at execution models. They explore innovative sourcing models to reduce cost and to increase flexibility and scalability.
Taren: That’s terrific. Kaushik, can you build on Srivatsan’s insights and discuss how transformation differs from operational optimization?
Kaushik: Certainly, when clients approach these processes, whether we’re talking about clinical data management, pharmacovigilance, or what have you, from an operational optimization standpoint, they're often looking at these as chains of activities in isolation, and they're trying to optimize them within each step, trying to identify what can be further done from a global sourcing model or increased digitization. And that certainly yields value and a lot of companies have gotten a lot of value using tools, such as Six Sigma, in this vein.
Transformation takes a much broader holistic standpoint and looks at these processes across the realm and often starts with the outcome associated with a particular process and asks how can this outcome be delivered differently, how can it be done better, faster, cheaper, and take a clean sheet approach towards the steps in getting there. And I think when clients take it from that transformation view, they yield a much greater output and different types of changes. So they can often see step function improvements in terms of what a transformation can yield versus operational optimization.
The challenge is that transformation often takes much longer timeframe than operational optimization, so clients often look to us to see if we can marry the two. We have an approach called transform while perform, which does precisely that – it allows clients to get the near term operational optimization of their processes while moving towards a broader transformation program that improves the outcomes in a much more step function manner.
Taren: That’s great. You had touched on the concept of value; perhaps you can tell our audience where companies should first to look realize gains.
Kaushik: We advise our clients to start with the most proven low risk process areas first. And I think within the life sciences sector, we've seen that in clinical data management, pharmacovigilance, and now increasingly in finance and accounting, in that order. These are becoming the sources of value to look at, the process areas to realize those claims. So this has been our advice to clients, and it also turns out it is the trend of overall outsourcing in this sector as well.
Taren: Srivatsan, maybe you can wrap this up and provide some best case samples of how companies can successfully make that transformation.
Srivatsan: Definitely. Most organizations start by trying to deploy clinical operations perform that are global, like the state of the art clinical trial management systems, EDC (electronic data capture) are platforms for clinical data management. Once they do that, they start to leverage standards, standards for information exchange, like CDISC, to enable integration of information across all aspects of clinical operations.
Finally, they try to ensure that the critical aspects of the organization, which is the people, are deployed in the most strategic activities which the organization desires.
Through the above mechanisms, clinical operations can transform itself while performing its core functions in a flexible, efficient, and scalable manner.
Taren: Your insights are terrific, and I want to thank you both again for sharing the importance of adopting the transformation process to change clinical operations.
If you're interested in learning more about Cognizant, please visit www.cognizant.com.
I want to thank you for joining us for this episode of the Industry Vision.
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