GenNext at SIRO Clinpharm

The COVID-19 pandemic has left its mark on the clinical research and trials sector, but disruptions have only served to temper the steel of long-timers. Clinical research organisations (CROs) are helping pharma companies roll out the COVID-19 trials and while this is a huge business opportunity, it is also fraught with risk. Besides the usual risks associated with testing new products, is the fact that the trials had to be run under severe logistical constraints.

In September, an analysis by Frost & Sullivan informed that with the increased threat of COVID-19 and worldwide lockdowns in effect, the CRO market is experiencing interruptions in ongoing clinical trials and delays in new trials. Recovery is expected to commence from 2023; although it will be staggered, it will take revenue to the original growth trajectory by 2024–2025. As per the revised forecast after the impact of the COVID-19 pandemic, the CRO market is estimated to garner revenue of $63.83 billion by 2024 from $43.03 billion in 2019, at a compound annual growth rate (CAGR) of 8.2 per cent.

The report titled, Hybridisation of Clinical Trial Designs Reviving Global CRO Market Post-pandemic; 2019-2024, reveals that hybrid clinical trials and remote patient monitoring are key trends driving the global CRO market. Hybrid clinical trials leveraging safety-focused, direct-to-consumer logistical solutions are taking centre stage, ensuring research continuity.

Surviving testing times

But disruption is not new to the global CRO sector. India’s CRO sector went through one such upheaval when new clinical trial guidelines were released in 2013-14 but the revised regulations of 2019 have steadied the sector. One of the CROs which seem to have survived this testing time is SIRO Clinpharm (SIRO).

Founded in 1996 by Dr Gautam Daftary, initially as a subsidiary of Bharat Serums and Vaccines, a company set by his father, SIRO is one of India’s earliest CROs.

The company enjoyed a good run, growing as the sector matured in the country, notching up 250+ clinical trials spanning the pharma, medical devices and FMCG sectors.

Regulatory speed breaker

The company took on private equity investors (PEs) in 2007 to scale up but a fresh set of guidelines for clinical trials in 2013-2014 halted not just SIRO but the entire sector.

Meanwhile, the second generation was ready to join SIRO. Post an undergraduate degree from Emory University in Economics and Mathematics, Dr Daftary’s elder son, Akshay started his career at Bharat Serums and Vaccines in 2014, moving to SIRO in 2018. He now serves as a Director, in charge of global business development activities and client management.

Post an undergraduate degree from Babson College with a focus on finance and entrepreneurship, his younger sibling Karan worked at the Puma Group for a while before joining SIRO in 2018. He is now Global VP, SIRO Clinpharm and is in charge of ancillary services including finance, human resources, quality assurance, IT, legal and corporate marketing.

As the second generation at the helm, Karan and Akshay witnessed how the stringent clinical trial regulations of 2013-2014 caused many large global companies to leave India, resulting in a large reduction in clinical trials in India. They narrate this had a sizeable impact on SIRO’s operations as well, which was dependent on winning complex studies from global pharma companies.

According to them, SIRO was slightly better placed to weather the turbulence as before this regulatory downturn, the company grew its medical writing vertical extensively to ensure stability and holistic growth of the organisation. This service offering brought “great stability” to SIRO’s operations with standalone and annuity clients in alternative geographies.

Survival, not revival

Both siblings agree that the new Drugs and Clinical Trial Rules launched in 2019 created a very positive shift in sponsor sentiment and a willingness to return to India for their global clinical trials. This has revived an industry that was undergoing a significant downturn.

The company underwent a brand refresh in 2018 and re-established its core mission of Helping Lifesavers Save Lives. They feel that SIRO has been a perseverant organisation that saw an opportunity in the downturn and hence their success story has been that of “survival, and not revival.”

Charting the way forward, the siblings reflect that there was no one single way of continuing their growth, but a series of factors that helped them maintain their strong position in the clinical research segment.

While growing the India operational team, the duo also has their sights set strongly on establishing an operational presence in the US in medical writing and biometrics.

Meanwhile, Dr Daftary bought back stakes from investors and other shareholders in 2017 to once again become 100 per cent owner, resulting in “simpler decision-making processes, lofty growth ambitions and supply of ample capital” to achieve their growth plans.

Impact of COVID-19 on clinical trials

The importance of clinical research has increased as we grapple with the COVID-19 pandemic and the possibility of more such pandemics sweeping our planet. But out of the disruptions due to COVID-19, came swift changes in regulations, to cope with logistical nightmares posed by lockdowns, heightened fear of transmission of infection, etc. In hindsight, these changes will be for the better.

Akshay and Karan speak about the limited access to healthcare facilities, state-wise regulations in India as well as resource constraints during the lockdowns. While there was an obvious challenge in opening new sites for trials, even running existing ones was a challenge based on strict controls that had been swept into place in the light of the dangerous nature of the pandemic. To ensure the safety of personnel, clinical trials were stopped at several sites.

On the other hand, recruitment challenges were amplified with participants in clinical trials finding it difficult to visit sites as often as required by several stringent clinical trials. Although this impacted SIRO as a CRO, sponsor companies were greatly affected as well due to delay in timelines which in turn impacted their stringently planned clinical pipelines.

The short term impact of COVID-19 was the need to handle many aspects of the trial remotely. To overcome this hurdle, while maintaining strict adherence to clinical guidelines, SIRO decided to initiate remote monitoring which enabled them to continue with sponsors’ clinical trials in the middle of the pandemic. This initiative was greatly appreciated as it enabled studies to continue.

SIRO also took many precautions while sending their employees to offices or sites as and when needed. The Daftary siblings narrate how technology has been a great enabler in transitioning many activities to a virtual activity – as has happened in the past, while technology has been available for long, its adaptation and penetration into specific aspects of business process is greatly facilitated by challenging times like the COVID-19.

They feel that the potential long term impact of COVID-19 would be the continued use of technology to bring about a paradigm shift in how clinical trials are executed, with virtual clinical trials with real-time monitoring through wearables connected to the cloud.

The duo reflect that while the regulations for clinical trials will continue to evolve, one of the main drivers for change shall be the situation that we have seen due to COVID-19.

The pandemic has thrown several challenges to the regulators. Firstly, in terms of fast-tracking a vaccine or a drug for a COVID-19 kind of situation and second, ways and means to overcome the constraints of lockdown like situation on the clinical research.

They anticipate significant changes in regulations to provide for/govern virtual clinical trials/decentralised clinical trials and the increased use of technology in the conduct of clinical trials.

The ‘Good to Great’ approach

When asked about their strategy for the future, the second generation at the helm quote from Jim Collins’ book, ‘Good to Great’, “Greatness is not a function of circumstance. Greatness, it turns out, is largely a matter of conscious choice.” This dictum inspired them to believe