Life science is a very important segment for information technology companies including Infosys. It is no doubt one of the most profitable industries in the world as well as highly regulated, with significant expenditure on IT. Investing for Clinical Trial Supply Management (CTSM) enhances efficiency and  collaborations between pharmaceutical companies and contract research organizations (CROs). We are seeing extremely positive response from clients across global markets including Europe, US and Japan, Ramesh J. Chougule, Associate Vice President, Life Sciences and Services, Infosys, tells Nandita Vijay, in an email. Excerpts:

How important is this segment of life sciences particularly clinical trials contributing to the revenues of Information Technology companies including Infosys?
Life science is a very important segment for IT  companies including Infosys. It is no doubt one of the most profitable industries globally besides being  highly regulated and this creates need for  significant expenditure for  IT solutions.  

The supply chain management (SCM) has evolved over the last decade and particularly for  clinical trials is there is need for considerable   flexibility. This is primarily because of the  dynamic nature of the outcome or results from clinical studies undertaken at various stages of drug development. All the  data ensuing from clinical studies need to be incorporated into the supply chain solution. Many pharmaceutical companies have tried to adopt SCMs used in non-life science  industries for clinical trials have failed.  This is because  CROs have very specific needs like randomization, study design, packaging, repackaging, re-labeling and the need to connect seamlessly to multiple players in the supply chain. Infosys CTSM solution offers cloud architecture, mobile technology as well as SAP HANA-based platform, which no other IT player can offer for the CRO space  currently.

How has Infosys fared with its CTSM in global and Indian market?
The Infosys CTSM solution helps life sciences companies enhance efficiency of clinical trial processes by driving greater collaboration between pharmaceutical companies and CROs. We are seeing extremely positive response from clients across global markets including US, Europe and Japan. With the launch of CTSM on cloud, we are also able to target mid-size companies with revenues  of  less than $5 million to expand our reach. Till date, we have not targeted India, but we have a few leads and are in talks with one leading pharma company in the country.  

Since 2008, the global economic scenario has impacted every segment of the business including clinical trials and in the case of India human studies were restricted following the Supreme Court in 2013. Have these unprecedented developments impacted the sales of Infosys CTSM?   
There has been no impact whatsoever. In fact, there has been a  huge demand for Infosys CTSM solution. Multiple clinical trials are implemented in global organizations in various parts of the world as this solution largely addresses the global needs and focuses on supply chain efficiencies.

What according to you would be an estimated size of the market?
If we are only looking at CROs and smaller pharma companies, then industry studies indicate the market size to be about $500 million for the Clinical Trial Solution.

There are several players in the space gunning for a share of the market for cloud-based solutions. Which are the key competitors in this space for Infosys?
We have the first mover advantage in this space as there aren’t any traditional IT service providers offering such a solution in the CRO space. There are smaller boutique product companies which offer services in the clinical trial space; however, none of them offer cloud-based solutions.

What are the key strengths of Infosys to compete in this market which also has the presence of dedicated solutions providers like Cytespace among others?
Infosys has a strong presence and capabilities in the SAP space. Our core skills in this space have enabled us to develop a solution that addresses the requirement of integrating business platforms to deliver industry-specific capabilities in commercial services, research and development, and supply chain.

Secondly, R&D has been a complex subject in the life sciences space. Therefore, it takes immense experience and in-depth knowledge of this sector to develop IT solutions that can help address the complex needs of CROs and pharma companies. We partner  with global pharma players to help address their business challenges. Our strong consulting and system integration capabilities and  focus to develop innovative solutions enable us to become the partner of choice for our clients.

Reaching across global pharma is a clear differentiator for Infosys. New  generation technological capabilities like SAP solution on cloud, SAP HANA, mobility have made  our solution far superior to those offered by the boutique competing players. In a life sciences market which is constantly evolving, we are ahead in providing futuristic needs of the CRO market.

How would you describe the current scene of clinical trials and contract research industry from a global and Indian perspective?
Clinical trial industry is evolving. There are a lot of inefficiencies that need to be addressed. This  space is becoming increasingly diverse as many  CROs and  CMOs are coming up. There is also backward integration taking place where  some CROs are trying to package, their in-house manufacturing capability to prospective  pharma companies. Currently, the clinical trials sector is undergoing a digital transformation. They need to have a robust solution which is easy to implement. CROs will adopt cloud-based model for cost effectiveness and are in the process of developing IT applications on cloud which has convenient accessibility through mobile. This is true for Indian organizations too though the IT solutions are tailored for the infrastructure availability in India. With cost of communication network reducing significantly every year, requirements in Indian scenarios are not going to be different than the global organizations in the near future.

Going forward how do you see solutions like CTSM to transform the space of human studies and contract research industry?
Earlier it used to take a couple of weeks to get the result of a clinical trial and build those into the changed supply plan. The time lag resulted insignificant wastage of material, resources and time.  With Infosys CTSM, this period has come down to days/hours from the earlier weeks. This goes to show how digitization is improving the efficiencies and productivity in the clinical space, leading to a decrease in costs. Infosys anticipates that this would reduce the cost of trial by 20%. The development of a new molecule in the pharma industry takes around 10 years and cost about US$ 1 billion. So, every pharma company is keen on using IT solutions that can reduce both - cost and time for new drug discovery.

Is the clinical industry convinced that the cloud based CTSM space is the ultimate solution in hand to transform the human studies as an efficient and transparent operation?
Cloud-based CTSM technology is definitely the solution that the CRO industry needs today. The cloud based solution reduces the initial IT investment significantly and considering investment appetite, CROs are likely to adopt a Cloud based solution. Apart from cost, there is a huge amount of data available and large amounts of interactions on the social media. Pharmaceutical companies are taking advantage of his in their drug development cycle. The IT ecosystem moving to cloud is a definite trend, starting with CRM, HR and then to other functional areas. So cloud based CTSM is the way to go.

What are the challenges in terms of installation of CTSM and marketing this solution to companies?
Infosys CTSM solution is SAP-based and smaller CRO players would have found on premise SAP installation an expensive exercise. To overcome this challenge, we have come up with a cloud based solution with customizable versions of the main solution. Based on the complexity of the need, the required version can be installed at each client company. Secondly, we have created open source integration with any technology that the smaller companies may be using. As the market for this solution is small, we have developed different sales channel as well as a separate marketing strategy to sell this solution.

How easy is it for Infosys to access the required qualified personnel to handle this knowledge intensive sector?
We have access to a sufficiently large pool of qualified personnel for our CTSM solution due to multiple factors being in our favour. Infosys has extensive experience in handling SCM for various industries, including the pharma sector.We have a strong process outsourcing division with a team of over 200 persons with research expertise in the pharma sectors,US FDA and regulations of different countries.

The availability of talent in the CRO industry, that is of specialists who are doing clinical data entry and analysis, is large. While some have joined Infosys, many more are interested in working for us. So, we have never faced any problem in getting qualified people in this area.

Apart from the above, we have 12,500 SAP professionals in Infosys and many have worked on SCM. We have special training modules for CTSM that are undertaken by professionals within Infosys and help them quickly come on board. Since SAP is the foundation for the solution, it has been easy for us to scale up these SAP professionals for the CTSM solution.

We have a great journey ahead in providing the most advanced IT solutions for the CRO space globally.