SIRO Clinpharm - A win-win situation

With the aim of fulfilling all CRO needs independently, SIRO Clinpharm is continuously enhancing its research capabilities both in domestic an international market. Chetan Tamhankar, CEO, SIRO Clinpharm, discusses the company and different opportunities in the CRO industry with Usha Sharma

What services is SIRO Clinpharm offering globally?

From our Europe and Indian operation, we are offering full CRO services, which include clinical monitoring, project management and planning, data management, biostatistics and statistical programming, medical writing, medical monitoring clinical trials supplies (in India only), regulatory liaison and clinical audit and quality assurance.

Could you throw some light on the latest strategic agreement between SIRO Clinpharm and CambReg?

Due to the fragmented nature of European geography, regulatory services many times pose a hurdle for many small and medium sized non European companies wanting to enter the European markets. We thought of facilitating and channelising the efforts of these companies. This is one very unique service as a CRO which we at SIRO thought of offering through our partner CambReg in UK. With SIRO having sizable delivery presence in emerging markets and access to customers from around the globe, we are looked upon as one of the leading CROs. The management of CambReg, therefore, thought of extending their hand for an alliance. The strategic alliance will offer full scope regulatory services to companies wishing to register human medicines in Europe, including new small molecule or biotech entities, biologics and herbals as well as generics.

Most of the MNC pharma companies are looking at Asia for outsourcing their early to late phase clinical work; in this scenario, how is SIRO Clinpharm positioned for this opportunity?

As I said earlier, SIRO is one of the leading CROs in India. In fact we established our office way back in Mumbai, India when the clinical research industry in Asia was at a nascent stage. Today, China, India and South East Asian countries like Taiwan and Korea are attractive destinations for conducting clinical trials for some common and few varied reasons. The common ones being treatment naïve patient population, epidemiology base in terms of having disease profile of the Western countries as well as the tropical countries and the huge cost saving potential.

However, amongst the varied reasons, the most important one is regulatory approval timelines apart from IP protection, tax incentives, infrastructure etc. Due to speedier regulatory approvals in India, TRIPS compliance since 2005 and SIRO's acquisition in Europe and various past and upcoming alliances, SIRO becomes a very attractive international CRO for global pharma and biotech companies to work with.

Till now, how many trials and sites have been successfully carried out by SIRO and in which therapeutic segments? Which are the new areas SIRO will be tapping in the near future?

If I look at last five years, we have conducted more than 300 clinical operations studies and approximately the same number of studies for clinical data management broadly covering more than 25 therapeutic segments primarily including oncology, diabetes, infectious diseases, cardiovascular, respiratory etc. Our entry into new therapeutic segments will be in line with our global strategy.

Globally we have worked with more than 3,000 investigator sites which in turn have recruited more than 70,000 clinical trial subjects. These sites are from diverse geographic locations but predominantly from Germany, other central and eastern European countries and of course India.

How big is your global footprint?

SIRO is an international company going global having its roots in India. With our operational presence in seven countries, we cover 17 countries globally. We have our offices in India, several European countries, Israel and USA.

We have definite plans of expansion in immediate future in other geographies like South East Asian countries and in near future to expand our base in the US markets.

We have worked with most of the top 10 global pharma companies and many top biotech companies. We also have sizable customer base of many small/start up companies in biotech space. Globally, we have 450 plus employees. Last month, we opened our new office at Czech Republic and have definite plans of further expansions in line with our global growth strategy.

As a rapidly progressing international CRO aiming at global operations, already there are tie ups lined up in the international markets and we are open for tie ups that are in line with our global strategy.

What are the new trends in the CRO industry, eg, in medical writing, clinical audit services and quality assurance?

Traditionally, CRO industry services market is phase III and phase II predominantly. Service type wise, it is the clinical operations, project management and clinical data management which constitute a major portion of the service pie. Of late, we are experiencing rapid growth in segments like medical writing, clinical audit and quality assurance. Apart from these, internationally there is an upward trend in areas of bio analytical services like immunology, central lab services, drug safety etc.

Why does medical writing in clinical trial activities look inviting?

Any service is in demand and looks attractive and inviting if you have competent and committed people providing the service at a competitive price. Many medical professionals in India possess industry experience and consequently know how to put together reports and analyse safety data. The primary language of higher education is English which helps a lot. There are certain skills required by medical writers like excellent communication, presentation, knowledge of information technology etc. The talent pool in India has all the abovementioned qualities and India can offer significant cost arbitrage over getting the medical writing done in West. No wonder does medical writing in clinical trials looks attractive from perspective of sponsor, CRO and for medical professionals themselves. It's a win-win situation for all stakeholders involved.

Where do you see SIRO Clinpharm by 2012?

Our mission is to provide exceptional drug development solutions through our passion for excellence and unwavering commitment. To attain this apart from providing a nurturing work culture, empowerment with accountability and recognition to our employees, fair ROI to investors which we have been doing, our primary focus in last couple of years has been on delivering the advantages of non traditional geographies through our expertise and customer oriented approach. We will also create niche presence in developed markets like North America before 2012, which will allow us to offer full services globally with strong delivery capabilities in emerging markets.

u.sharma@expressindia.com