Dr. Aditi Datta

Founder & Managing Director

The global Contract Research Organization market size is anticipated to reach $51 billion by 2024. Drug develop­ment is not only a lengthy, complex and costly process, but it is also entrenched with a high degree of uncertainty that a drug will succeed. Clinical Research Organizations are orga­nizations that are contracted by another company to take the lead in managing that company’s trials and complex medical testing responsibilities. CROs mainly reduce the cost of re­search & development to help businesses & institutions meet the needs and requirements of the evolving medical device & pharma industry.

Over the last few years,India’s regulatory environment has improved significantly and the New Drug Clinical Trial Rules that were formalized in 2019 are balanced & well received by the global research community. Nearly a fifth of all trials globally are hosted by India which are having huge potential for financial and scientific gains. CROs are taking an edge of gaining a large pool, qualified medical investigators, lower drug development costs and winding up the clinical trials in India on time. While the market is becoming competitive with large CROs going for acquisitions and mergers to increase their portfolio and reach, small and medium CROs are becoming more prominent with their personalized approach, contract flexibility, and budget-friendly services.

One such leading Mid-sizes CRO in India in the latest research, working with pharmaceutical companies and patients in PAN India is Bangalore-based Biosite Research. The company provides full and functional clinical research solutions to the biotech, pharmaceutical, and medical device industries worldwide. The team of Biosite Research comprises 100+ years of expertise in designing, performing, and translating complex clinical studies while upholding the highest standards of ethics.

In an interaction with Pharma Industry Outlook, Dr. Aditi Datta, Founder & Managing Director, Biosite Research, shares her views on how Biosite Research is accelerating clinical trials with faster site selection and patient recruitment.

What are the major expectations of clients from Contract Research Organizations? How do you meet those expectations?

Our clients look for the authenticity of the research data. As far as USFDA is concerned, we have witnessed several regulatory and other audits where Indian pharma research organizations have performed well. The precision of work and the speed at which the research is conducted are the major aspects. Therefore, clients mainly look for Precision, auditable work, good clinical practices, and authenticity of research data.

How is your company positioned in this market?

We see ourselves as a growing organization and already have our presence in the UK. Moving ahead, we are in talks for global clinical trials as well. We focus more on quality, and not on quantity, and hence this helps in ensuring a work-life balance. Although we work on several projects for our clients we aim to render the best services and not compromise on the quality.

Please elaborate on the various services and solutions that the company is known in the market for.

We are known for doing the fastest clinical trials and managing big recruitment targets. For instance, we have the capability and facility to handle around 400 or 500 patients. We are able to manage this with the help of our database and the support of the opinion leaders that we have in the market.

What are the various differentiating factors that set you apart from other players in this landscape?

What differentiates us is the commitment and oneness of our team. We are always available for our clients. We do not see it as a task that is handed over by the clients to us. We do it with a lot of zeal and passion. This is what has helped us grow in this sector and maintain a work-life balance as well.

Tell us about the overall infrastructure with respect to your laboratory, technological integration, and also the combined experience of the team.

Leveraging technology not only helps in accelerating your work but also helps in being transparent to your clients. In order to obtain a clear picture of what we have incorporated technology in our CTMS and use quality tools. We have also automated financial tools which help in tracking the financial payments for investigators.

Biosite Research uses different platforms such as quality platforms and data platforms as well as tools that enable completing the task at a faster pace. For instance, during the COVID-19 pandemic, when everything was paperless owing to remote monitoring and remote audits, we installed platforms both at the hospitals as well as our central data center. Both the teams would collaborate and capture the data most accurately. And this was possible only with the help of technology. Also, another instance is where we were able to conduct studies related to COVID, during the pandemic. While half of our team was on the ground the rest of the team supported in completing the project by working remotely.

What is the future roadmap for Biosite Research? How is the company gearing up for the same?

Currently, we have our presence in Bangalore, Delhi, and London. We would like to establish our presence worldwide and are looking forward to working with like-minded CROs. Also, we would want to develop a robust system through which we can conduct clinical trials in several countries, and not just in India.