‘Our aim is to make sure that patient safety is achieved at the end of the day’

Dr Vatsal Shah has been associated with SIRO Clinpharm since the last three years. He recently took charge as the Chief Operating Officer of the company. Shah, in an interaction with Usha Sharma, talks about the company’s ambitious plans and some of the challenging tasks which he has undertaken to maintain the company’s growth trajectory

What are your learning experience at SIRO Clinpharm?

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Dr Vatsal Shah

The biggest learning has been the answer to a very intriguing question: Why do some of the world’s largest biopharma companies turn to SIRO for their drug development needs?

Over the years, SIRO has gained versatility and earned a rank amongst those very few CROs in India that could support end-to-end clinical studies with all services inclusive of clinical trial supplies management. How a culture of innovation has allowed SIRO to raise the bar rather than being cocooned in its comfort zone is a lesson in itself! SIRO has been the only CRO to have set up independent services outside clinical operations in medical writing, clinical data management, biostatistics and statistical programming, clinical trial supplies, data analytics and medical communication. It can boast of sizeable groups for each of these domains, including the largest medical writing group on this side of the world so much so that an equal contribution or more comes from SIRO’s non-Clinops business as it does from Clinops business per se. By virtue of these, SIRO can adapt with ease to FSP-FTE-full scope engagements as is evident from our long standing contracts with top global pharma clients and their local regional and Indian affiliates.

In recent times, even while the evolving regulatory situation in India pushed several wanting firms out of business, SIRO’s ‘never say die attitude’ has allowed it to run with its head held high, without any global funding or affiliate, that too with a respectable EBIDTA. Although, SIRO is the oldest name in clinical research industry in India, its young but experienced and enthusiastic professional team teaches you how to age like a veteran and still perform like young blood. SIRO has undergone tremendous change in the last several years, three years in particular, and I am glad to have been a part of it — then and now. In my tenure here, I have seen the industry at its best and its worst. Being part of such a dynamic industry has taught me how to make quick decisions, how to always be proactive in taking the right measures to ensure that we are abreast of competition, and, foremost, how to learn the importance of ensuring proper governance in every segment of the services we offer.

Tell us about your responsibilities as the Chief Operating Officer?

The responsibilities pretty much remain the same, though the accountability towards several activities, including the overall sales, delivery and finances has tremendously increased. This however, is an opportunity in itself since nowhere else would a platform like this be made available to maximise integration and cross-utilisation, to optimise operational efficiencies and to maintain robust central governance. The metrics-driven culture and analytical dashboards, which have been the hallmark of SIRO and are much sought-after by clients, would now be integrated and implemented with ease across the board. We have been representing SIRO on various national and international forums, and the stakes only increase with a more consolidated and strongly integrated team as in SIRO.

Recently, the Indian clinical research industry has gone through tough times. Tell us how difficult it is to remain in the business and survive.

The change in the regulatory framework is an evolving process across the globe and it is always aimed at improving the conduct of clinical trials. So is the current regulatory scenario in India. However, often these changes pose challenges in actual execution of the projects and those CROs found wanting fell off the radar. SIRO, however, in its journey in the clinical research industry for nearly two decades, have had the opportunity of interacting with the top pharma companies across the globe. Such a level of exposure has taught us to provide the industry with just the right solutions, allowing us to remain afloat even when a number of other CROs have gone under. While continuing our focus on the ‘CRO core competency’ of clinical operations and strengthening our flourishing medical writing and data services business, we have consciously had a paradigm shift in business operations. There is a renewed and sustained focus on newer areas of growth like medical communication, data analytics, clinical trial supplies, transparency initiatives including redaction, TA alignment involving dedicated vaccines and devices experts, Clinops as an FTE-FSP business, FMCG as an independent sector and so on.

Reiterating my earlier stand, the evolving regulatory situation in India may have pushed several CROs found wanting out of business, but SIRO’s ‘never say die attitude’ and ‘innovative business models’ have allowed it run seamlessly, without any global funding or affiliate, and with an appreciable profitability.

India lags in maintaining research data which is becoming a severe compliance issue in the industry. What needs to be done to tackle this issue?

I would not like to generalise on this. India still retains its respect on the global clinical research map as a major research hub and drug development partner. While I would admit it has been challenging for many to meet the stringent, but necessary global research requirements, it is largely the company’s quality culture, domain expertise and executive governance that determine its adherence to compliance. Being a part of the global drug discovery process is one of the key factors that motivate our company to continue its pursuits to transcend new heights, the regulatory restrictions notwithstanding. And the reputation we have built over the years while globally delivering successfully for renowned clients only enhances this motivation.

As a company, our aim is to make sure that patient safety is achieved at the end of the day and the data generated from the trials handled by us is acceptable across the globe. A testimony to this fact is the number of successful regulatory inspections and audits, including US FDA inspections, handled by us as a company without a single critical finding.

What are your plans for the next two years?

This industry calls for an organisation to always be on the change. My focus will be on enhancing the share of integrated service offerings across the clinical development spectrum. While there will be significant thrust on medical writing and data services that enjoy steady revenue streams, there will be undivided focus on competency building and quality delivery in newer and niche segments like MedComm, Analytics, Regulatory Consulting and Devices/ FMCG sector, which will contribute significantly to the next phase of SIRO’s growth. In the next two years, SIRO will aspire to be the perfect strategic partner for any clinical research requirement. SIRO’s transformation to a customer-centric organisation with a new brand identity couple of years back, and enhancement of Clinops execution capabilities in the APAC region will provide a perfect platform to achieve this.

All in all, we will continue to work towards providing a differentiated customer experience through simple, novel solutions to every client.

u.sharma@expressindia.com

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