‘Our vision at Navitas is to be the best knowledge company in the Life Sciences R&D space’

Information technology has become a crucial part of pharma industry helping it streamline itself. TAKE solutions has recognised this need by launching a new business arm. Srinivasan H R, Vice-Chairman and Managing Director, TAKE Solutions enumerates future plans in an interview with Shalini Gupta

Why did TAKE solutions launch Navitas? You were servicing life science clients earlier as well.

With Global IT spends by pharmaceutical sector estimated at 3.4 per cent of their annual revenue, Regulatory Information Management market (Products & Services) estimated at $1 billion and Clinical Data Management (Products, Services & Technology) at approx. USD 3-4 billion, we are looking at a mammoth market with a scope for immense growth.

The complexity of data and process is unique to pharma industry. This is where we have implemented our deep subject matter expertise, technology solutions, and business services enabling customers to swiftly and reliably move towards a unified approach of combining strategy and expert advice with efficient operations, empowering them to be compliant while being competitive. Our products, solutions and business services have resonated well with customers, enabling them to address needs within the R&D as well as the commercialisation areas.

This encouraged us to make the strategic decision of creating a wholly-owned subsidiary of TAKE Solutions called ‘Navitas’ in order to capitalise on our strengths in this domain. Our move to create a new brand is to meet the demand of this market for a niche player, in time to emerge as a competent and differentiated brand. Navitas, a pure-play life science solutions company, is a result of our new go-to market strategy. With the launch of Navitas, we can truly call ourselves as domain experts in the areas of clinical, regulatory, safety and compliance. We pride ourselves on our industry insight, our simplification approach and our pragmatic solutions.

What is the vision for Navitas? Would the services/ offerings remain the same or have you restructured/ repositioned them?

Our vision at Navitas is to be the best knowledge company in the life sciences R&D space by delivering the products, knowledge process outsourcing services and domain consulting expertise that the position entails. Navitas comprehensively covers consulting, technology, and outsourcing (functional services) across the clinical, regulatory, safety, and quality/ compliance functions for the life sciences industry.

What percentage of TAKE’s total revenues comes from life sciences annually? By how much has the business been growing Y-o-Y?

As of the quarter ended September 30, 2014, 61 per cent our revenues came from life sciences. There is a demand in the global pharma/life sciences market for regulatory compliance and customised solutions to meet business needs. The total addressable market of the life science industry is valued at $15.9 billion.

How have your services/ offerings changed with the growth in the life sciences industry? Which are most preferred services business wise contributing to the revenues?

We have always believed in deep subject matter expertise in life sciences and all our investments to date reflect our vision of being a comprehensive and a global collaborative partner to the bio-pharmaceutical and medical device industry. The growth in the industry has only highlighted the challenges of sustainable revenue growth with better margins against the backdrop of an increasingly stringent global regulatory regime. Navitas provides a very unique top down CxO advisory supported by collaborative industry networks. We guide our customers through change management, governance, process overhaul and organisation redesign and keep the industry well informed and hand hold them through transformations. We have adequately complemented this capability with organic technology offerings coupled with strategic partnerships with enterprise software companies. We have a service enablement capability which is very operational oriented and provides high quality and cost effective, value-added outsourced services, as evidenced by our ‘industry first’ accomplishments of unit pricing per deliverable and other significant efficiency metrics. We are quite clear that this unique approach to solving problems is essential and we will be attempting to grow them all and contribute equally to our revenues.

How has the slump in the clinical trial industry affected business?

We are not witnessing a slump in the global clinical trials industry. On the contrary, we are seeing a surge. If this question is to specifically address the situation in India, we are currently not participating in the Indian clinical trials market. We are monitoring the developments closely and are well prepared to participate in the Indian market when the situation warrants it. In fact, we are very well branded in the Indian market due to our flagship software portfolio, PharmaReady, that enables regulatory document management, document and submission publishing (electronic and paper), submission registration, tracking, and management as well as other content management solutions. We have also been very busy implementing drug safety systems, CAPA, QMS, and Track & Trace systems for our customers in India and the region. We are well poised in mind and market share to partner with our customers in their clinical trials area when the opportunity resurfaces in India.

Are Indian companies and MNC pharma utilising pharmacovigilance services?

Yes, it is mandatory for all companies without exception to be accountable for safety, adverse reactions or any other issue relating or subsequent to the launch of a drug. This accountability is a necessity and not an option.

Pharma companies globally have been in the red for drug safety violations and fudging clinical trial data. How, then, do you think companies such as yours and the services you provide can be counted as reliable?

Firstly, to place all pharma companies under this bracket is not fully accurate. As a business enabler and solution provider, the target of Navitas is to provide data-related service and derive inferences from the existing content given by the sponsor company. We are specialists in interpreting data and results to enable submission. It is not in our place to make judgments, challenge or determine the veracity of this data.

What technologies do you see as futuristic in the areas that you serve?

We are already working on the next generation of cloud-based regulatory IT tools that will radically change the way regulatory information is managed in the next several years. Technologies that would help support data transparency and collaboration as well as predictive analytics will drive the future. Real world evidence and outcomes based treatments will increasingly become the norm, and there will be a surge in the design of new and novel clinical trials that will produce more effective and safe drugs and procedures aimed at personalised medicine.

We are currently engaged in pilot exercises aimed at analysing Drug-ADR (Adverse Drug Reaction) co-occurences for a more effective and timely signal detection and management methodology. Upon scaling across several thousand drugs, this data could also be utilised for drug-drug interaction analysis, off-label usage of drugs, substance misuse, unmet clinical needs and better design of clinical trials and patient recruitment strategies and several more use cases. We are encouraged by the initial findings and hope to scale this platform using the Hadoop infrastructure and launch specific B2B and B2C solutions and services.

What role do you see technology providers such as yours playing in the life sciences industry in the future? What would/ does make you indispensable?

Navitas is not a mere technology company. It is a business enabler that has the ability to view the niche domain it operates in differently, thus delivering better outcomes for the pharma/ biotech industry in the form of lowered costs and faster time to market.

What are the future plans? By how much do you see Navitas growing by?

Going forward, we are going to invest more in developing critical IPs, delivering products/ services that lower the costs and time to market for our sponsor companies. We envisage a CAGR of 25 per cent for Navitas.

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