UK-headquartered QED Clinical Services, recently, enhanced its global delivery of clinical trials by creating a wholly owned subsidiary - QED Clinical Services India - in Ahmedabad, India. This expands QED's capacity and capabilities to offer global coverage to continue to successfully deliver high quality, cost effective projects. Mr Thomas Ogorka, CEO, QED Clinical Services talks to BioSpectrum about company's expansion in India.

Can you please elaborate on the work that will be undertaken at QED clinical India?

Mr Ogorka: India is not only perceived as a key location for service provision in the Asia Pacific region, but also as a component that contributes to the delivery of global services. QED is excited to offer better access to proven skills in delivery, a significant patient population that can contribute to global studies and the chance of better access to new medicine for the local population. QED offers its customers access to:
clinical monitoring and management; project management; regulatory affairs and regulatory consulting; site management and site support services; feasibility and site identification; patient recruitment and retention services; safety and pharmacovigilance; data management; and market registration for imported products.

What inspired you to choose India over other Asia Pacific countries to locate a subsidiary?

Mr Ogorka: India is perceived as a "must have" capability in the eye of the pharmaceutical industry. Besides, local market understanding is the best way to access the talents of the development team as well as the patients. With a huge patient pool (17 percent of global population with 20 percent of global disease burden), and a balance of treatment, naïve patients on one hand and high standards of care on the other, there are extensive capabilities to meet different study needs, rapid recruitment, world class infrastructure, facilities and trained manpower.

There is also the strong ability to deliver niche as well as volume-based services from India. For QED, our operations in India will also serve as hub to support services in other neighboring countries ensuring further regional control of our local partners.

How important is it for QED to have a presence in the Asia Pacific market?

Mr Ogorka: QED has a 10-year heritage of delivery and customer focus with increasing access to local knowledge to deliver global, regional or multi-national full service studies. The QED emphasis on customer service means that we listen to the needs of our customers. It is clear that Asia Pacific is an important and developing need for small to mid-sized customers as well as big pharma, and QED has therefore invested in the highest quality of local talent and service offerings in the region to ensure that customers can access full service capability with the added comfort of the emphasis on service that our model is able to offer.

What is the progress of the site? Is it ready for operations? Who heads the India operations?

Mr Ogorka: Its fully functional and we are already delivering projects for international sponsors.

QED operations in India are managed by country head and director of operations - Mr Ali Sajjad Bohra. Ali holds a Masters of Pharmacy (M Pharm) degree with specialization in Clinical Pharmacy and Pharmacy Practice (Gold Medalist) from the exalted National Institute of Pharmaceutical Education and Research (NIPER), India. He has extensive industry experience and has held leadership roles of increasing responsibilities with the most recent being as regional director - clinical operations for Asia-Pacific region for a large global CRO; where he was responsible for leading the clinical operations team across the Asia Pacific region with focus on assuring quality, consistency and efficiency of monitoring services.

He brings experience of executing large global programs and complex studies in major Asia-Pacific markets such as India, Sri Lanka, Pakistan, Japan, Singapore, Malaysia, Philippines, Thailand, Hong Kong, Taiwan, South Korea and Australia. He also brings leadership experience in managing and delivering large functional service projects (FSP model) in India for global clients.

There are already quite a few CROs operating in the country. What makes QED different?

Mr Ogorka: As a unique international and highly customer focused CRO, QED has proven that the focus offered from a flexible specialist model is of significant benefit. QED's specialty is achieving high quality by better management of cultural integration, alignment of interest and therapeutic skill and capability to access multiple countries with the confidence of local knowledge. This allows for seamless delivery of full service international projects with a feeling of local confidence.

In addition, successful delivery is dependent on an effective talent management strategy that targets the major obstacles that still make companies hesitate to conduct trials in India (e.g. perceived site and other infrastructure challenges)

At QED, we provide customized and cost efficient solutions as per the client needs with focus on measurable high quality deliverables. Quality remains the prime focus at our operations as well as at investigator sites with whom we work. We place ourselves as being reliable/trustworthy partners to our clients rather than a typical CRO-client relationship. We build long term relationships that enhance repeat business and offer highly experienced and trained manpower to ensure quality outcomes.

What is unique is quite simply that customers both large and small can now work with a CRO that has established its reputation on service and delivery through access to local energy and commitment to full service projects and programs. In a nutshell, at QED great services are delivered with great service!

What is the outlook of the company?

Mr Ogorka: We have a vision that people really make or break the success of complex clinical projects and that the commitment and focus of people who have aligned values and customer focus can make a difference for our customers. There is clearly an emerging need for new ways to access the world's experience in getting better medicines to more patients. We will build relationships and work with talented people wherever we need to ensure that we stay agile and flexible as a partner to the pharmaceutical industry and we are proud to have taken this step to strengthen our position in the Asia Pacific region. We expect to continue to grow and flourish as we deliver on our promises and cement our base of satisfied customers.