The business of clinical research outsourcing

The business of clinical research outsourcing

Karmic Lifesciences, a clinical trials and clinical data management services company, is now gearing up for its next level of growth by clinching contracts from global pharma companies

S. MEERA

Prior to starting Karmic Lifesceinces (Karmic), Nidhi Saxena worked in the IT and BPO industry for over 15 years in several project management roles. She felt the urge to start something on her own, one that would give her the room to innovate and, possibly, give back to society as well.

After weighing her options, Saxena zoned in on starting a contract research organisation for the pharmaceutical and healthcare industry, an opportunity with a market size of US $30 billion – US $40 billion according to research conducted by Connecticut-based IMS Health. She specifically picked contract research not only for its potential market size but also because leading an organisation that would work on next generation research in healthcare, excited her. Moreover, her services industry background and project management skills would come in handy as well.

As she points out, starting a venture needs an entrepreneurial bent of mind, and the ability to identify and hire the right team to get it going. And her initial years were focused on understanding how the industry works, the kind of people it would require and hiring them, developing the business plan, getting the licenses, raising money and finding the anchor client.

Off the Ground

Today, Mumbai-based Karmic Lifesciences’ core business is servicing pharma and medical devices companies design and test their products using the standardised protocols and analyse and manage the data generated. Till date, the company has executed over 65 clinical trials and over 75 clinical data management projects for clients across the globe. It raised venture capital from various angel investors including the India Angel Network, Mauritius-based Basil Growth Corp, Mumbai Angels and Blume Ventures.

The company’s 112 strong team services global pharma and medical devices companies from the US, Europe to the APAC region and all major Indian pharma companies. The company subcontracts a part of its work, but has automated the clinical trial process on an indigenously developed portal that enables clients in data management as well as process control. In fact, Karmic is also licensing this portal to its partners, thus generating another revenue stream. This has also given it an edge over its competition.

The clinical trial in itself does not enable Karmic to have any direct role in innovation, so one of the key strategies is to invest in a licensing and development process on a revenue sharing basis.

Investing in Quality

One of the critical areas of research and development in this segment is quality assurance. While Karmic is ISO 9001:2008, ISO 27001:2005 certified and ICH-GCP compliant, it has also built in the quality process in its automated solution so that every aspect is measured and tracked. Saxena herself is a Six Sigma expert and she has initiated several projects for waste and error reduction.

In addition to that, periodic external auditing ensures transparency and quality adherence. In cases of time delays or any lapses, it is immediately addressed through the processes put in place to address them.

The core focus for the company currently is oncology since that is the biggest market at US $75 billion-US $80 billion (according to the IMS Health study) and expected to be US $83 billion–US $88 billion by 2016. It also does work in cardiovascular, endocrinology and other such therapeutic areas.

Dreaming Big

Karmic has big dreams – of becoming 250 people strong in two years and of achieving US $50 million topline in five years, maintaining a 100 percent growth rate, year on year. For this growth, it is planning to strengthen its presence across the globe and follow a distributed model. “Clinical trials need access to different races for testing, and to run those centres, distributed leadership and localised empowerment are crucial,” points out Saxena. It needs several entrepreneurial people who can run the centres independently and take quick decisions.

Going forward

Last financial year, the company touched revenues of about Rs. 8.5 crore (till February) and started operations in the U.S. with two full-time people and eight contractors. The company recently clinched deals with pharma companies in Israel, Australia, Korea and the U.S. Karmic has also roped in senior folks from Glenmark and Wockhardt into its team.

The company uses various strategies to keep its workforce in sync with Karmic’s big plans. Specifically, employee stock options and profit sharing is offered to key employees and internal learning and leadership development and training are seen as a crucial part of the operational process.

Going forward, the company is looking at raising a Series B round to the tune of US $6 million- US $8 million. This will be used to expand into global markets, execute on the pipelines of new deals it has already secured and further build its team.

One challenge it faces is that of government policy framework in India where the Indian research model is still not stabilised. The government needs time bound systems so that it can firm up regulations quickly to match global standards to give Indian research and development organisations a level playing field.

Another equally serious problem is that of finding investors for R&D. “Sometimes you invest millions and the product fails. Many do not want to fund because of this reason,” she admits. Though she says Karmic is self-sufficient as of now, she is looking to raise another round to enable its expansion. But she is also clear that she will only go with venture capitalists firms that understand and share her passion, leaving her independent to focus on her core business.

In this context, her advice to aspiring entrepreneurs is to have conviction in their beliefs and fire in the belly. “Don’t get influenced by your funders, your spouse, or anyone else. Entrepreneurship is a highly personal thing, and become one only if you do not fear failure and are ready to take a risk for what you feel passionately about,” she says firmly. She also believes in personal integrity and taking the slow but the longer route to achieve her goals.

She received the Indian Leadership Award for Industrial Development in March 2013 from the All India Achiever’s Foundation and says that financial success is not the only yardstick for success, but how it inspires others. “It also creates pressure to keep up the standards. I think what is more important is personal satisfaction,” she adds.

Saxena is raring for growth, but is sure that she would not take short cuts to reach where she wants. Organic and inorganic growth are on the roadmap, and she will take one step at a time, as the opportunity arises, so that Karmic Lifesciences – named from the Sanskrit word Karma or action and detachment from results – can be reckoned for its quality and delivery in clinical research.


Snapshot

Karmic Lifesciences

Founder: Nidhi Saxena – President & CEO

Focus: Clinical Research and Clinical Data Management

Founded in: 2005

Funded by: India Angels Network, Mumbai Angels, Basil Growth, Blume Ventures


Concept in brief:

Contract Research forms an integral part of the healthcare industry as many pharmaceutical and medical devices companies outsource their design, testing and data management processes. Karmic Lifesciences was formed in 2005 when Nidhi Saxena, who had 15 years experience in project management in IT and BPO industry, decided to start a life sciences company. She raised Rs 10 crores in seed capital and has established a base in India with offices in the US, Europe and APAC. The company not only is a part of the testing process but also co-owns the development process to give it a stake in product development. Now, Saxena is looking to raise a Series B round to the tune of US $6 million- US $8 million to enable the company to achieve its goal of US $50 million in topline in five years.