IQVIA conducts over 45 vaccine studies in India during last 5 years

By Ayushi Jain

New Delhi: “IQVIA has conducted over 45 vaccine studies in India, enrolling more than 70,000 participants across various trials in the past five years. The company’s involvement in COVID-19 vaccine studies and its ongoing work on dengue and cholera vaccines further underscores its expertise in this area. The company’s ability to recruit subjects and execute studies efficiently has been a key differentiator,” stated Kirti Narang, Associate Director Clinical Project Management, IQVIA while highlighting how vaccines are an important case study for India’s growth in terms of affordable product innovation.

Narang spoke at a webinar titled “India Local Solutions (ILS) Center of Excellence: Vaccines and Biosimilars,” held by recently by IQVIA where a panel of experts discussed India’s growing role in clinical trials for vaccines and biosimilars.

The event highlighted IQVIA’s expertise in conducting local studies, its achievements in this field, and its future prospects.

Narang spoke on importance of vaccines in India’s healthcare landscape, noting that the country has become a global hub for affordable vaccine innovation. “IQVIA’s success in vaccine trials is driven by its extensive site network, comprising over 130 locations across India. This network has enabled the company to meet recruitment targets ahead of schedule and efficiently execute studies.”

Narang explained that early engagement with investigators and thorough site preparation are key factors in ensuring smooth study execution.

She highlighted IQVIA’s ability to complete a phase 3 cholera vaccine study involving over 1,800 volunteers within a short timeframe, demonstrating the company’s operational efficiency. This success is largely due to the strong relationships built with site teams and the early engagement of investigators during the planning stages. “We start engaging with the customer at the pre-award stage,” Narang emphasized, underlining the importance of understanding the operational needs early on to ensure smooth study execution.

Bhairavi Bhinde, Head, Operations India Local Solutions & Avacare provided an overview of the India Local Solutions (ILS) model. Bhinde explained that the flexibility and efficiency ILS framework, designed to cater to single-country studies, enables IQVIA to deliver high-quality clinical research efficiently in India. “India Local Solutions is a small CRO in a large CRO of IQVIA,” she said, emphasizing that the model offers flexible, bespoke solutions while adhering to global standards. “Over the past seven years, IQVIA has completed over 100 studies across various therapeutic areas, achieving a 91% rate of on-time or early delivery​.”

Sachin Sadekar, Associate Director India Local Solutions, R&DS India then shifted the focus to biosimilars, an area where IQVIA has established a Center of Excellence. Sadekar emphasized that IQVIA has conducted over 88 biosimilar trials globally across multiple therapeutic areas, including oncology, rheumatology, and dermatology. “IQVIA has brought experience into biosimilars, conducting trials for 33 biologics since 2009,” Sadekar noted. The company’s strategic approach, which includes early regulatory consultations and data-driven site selection, has been instrumental in the success of these trials.

One of the key takeaways from Sadekar’s presentation was the importance of IQVIA’s Center of Excellence for Biosimilars. This specialized team works across various therapeutic areas to provide end-to-end support for biosimilar studies. From regulatory consultation to innovative approaches in clinical development, the Center of Excellence ensures that each study is tailored to meet the specific needs of sponsors. The collaboration between biosimilar experts and therapeutic area specialists allows for optimized study design and efficient recruitment strategies, which are essential for the success of biosimilar trials.

The webinar concluded with Sarang Vinze, Associate Director Patient and Site Services, R&DS JAPAC discussing the Oncology Biosimilars Network initiative. This global initiative focuses on optimizing site capabilities and ensuring faster timelines for biosimilar studies.

Vinze highlighted the importance of site readiness, noting that IQVIA’s vetted site network across India and other regions has enabled the company to deliver better outcomes for sponsors. “The biosimilar landscape is going to be very interesting in the next few years,” Vinze remarked, pointing to the expiration of patents for several key oncology drugs by 2030, which presents new opportunities for biosimilar development​.