Which office are you located at?
GCT openedan office in India in 2017. Since the beginning, I am based out of our Indian office in Powai, an eastern suburb of Mumbai. Powai’s is an upscale township within Mumbai, where there many IT/ITES, Research, Consulting Companies, and Banks are located.
What can you say about India’s involvement in clinical trials?
India has emerged as a hub for global clinical trials and has already proved its position by participating and contributing to international trials in the last two decades. The vibrant pharmaceutical industry in India has showcased its strength globally in generics, biologics, and vaccine development. The regulatory framework of India has achieved landmark significance globally due to its stringent guidelines and newer approaches to clinical trials. Indirectly, it has slowed down the pace of the growth of the clinical research industry but over the last few years, it had shown signs of improvement and re-acceptance for more global trials. For the global pharma industry, India will play a major role in clinical research due to its huge population, market size, IT savvy, and qualified professionals both at the industry level (managers) and at the hospital level (doctors, nurses, etc).
How long have you worked here? Can you tell more about your role and background?
I have been working at GCT India since its inception in 2017. It has been wonderful 4 years working with GCT, LLC. Regarding my background, I have more than 20 years of experience managing full-service operations in Asian countries for global CROs. Within GCT, I am responsible for country management and business development within India. I am also in charge of project management and biometrics operations (data management, biostatistics, and medical writing).
How is the COVID situation in India? Is it hard to stay afloat?
Covid is continuing to make a dreadful impact on the life of the Indian people. We were very happy when the 1st wave was within manageable limits and we felt, we were lucky to escape the worst situation in India. But the 2nd wave was devastating. We felt somewhat lucky to have two vaccines manufactured in India. But that was not enough for the size of the population in India. So, all the advantage of the population for our CRO industry has now seen as a serious challenge for logistics and management of quick vaccine administration in India.
How is the CRO business progressing in the times of Covid?
My understanding is that there are a lot of activities around covid trials globally, but other pipelines are also active just shifted to decentralized and remote model. Remote monitoring is often the new norm in the covid era. The sites are reorienting themselves from manual 100% source data verification (SDV) to partial remote monitoring using tools and technologies. Most regulators, including India, have fast-tracked COVID applications.
What’s changed at the company since you’ve joined?
GCT has grown horizontally and vertically. GCT has expanded into many new countries in Europe and CIS countries. GCT has also added new services, providing in-house data management, biostatistics, and medical writing services, and pharmacovigilance services. Our USA operations have strengthened and expanded. We have started winning more multi-centric global trials involving many countries/geographies.
What is important for you at GCT?
Respecting local expertise, granting freedom to operate locally under a global framework, and facilitating a friendly professional work environment based on mutual trust — all these things are unique about GCT. I respect this value proposition of working here as it is what I believe in.
Can you describe an event that was particularly memorable during your career at GCT?
There are many memorable events. Starting from completing the Indian legal entity as planned in record time, setting up biometrics’ SOPs and processes -that is something fulfilling and memorable.
What was the moment when you knew you had made the right decision to work here?
I remember my first communication with Jeff, our President, and my first teleconference with Eugene, our CEO. But the real confidence I gained when I met Eugene in person and discussed the shared objectives, then I felt, it matches, and I can work and contribute.
What do you think the mission of GCT is?
The mission of GCT is to continue growing as an unparallel full-service provider in emerging countries and provide personalized and holistic services for drug development in the interest of the community at large.
How do you see GCT in 10 years?
I see GCT growth adding multiple offices in Asia and the Middle East in addition to strengthening the existing teams in the USA, Europe, and CIS countries. GCT will adopt many more trial management tools and adapt to technological changes with the growth of the industry.