At a time when the US slid into a recession and the blush of pink slips became a norm, Nidhi Saxena hit upon the idea of starting a contract research organization in Mumbai, India's finance capital. The company christened as Karmic Lifesciences, has been operational since June 2008.

Now into its fourth year, the company plans to focus on kSuitetm a proprietary platform for large multi-centric trials in the life sciences industry. kSuitetm is a web-based, Clinical Trial Management System (CTMS) designed to support end-to-end operational activities like project planning, budgeting, set-up, execution, performance and reporting for all its clinical trials. kTrials is its latest offering. "This year we will launch kTrialsTM v2.0, a fully integrated CTMS plus EDC plus SDTM Mapping tool. This has been tested on iPad and iPhone compatible CRFs and they work like an Electronic Data Capture form. Also on the agenda is the eTrial Master File (eTMF) which will be integrated into kTrials," said Saxena, founder, president and CEO of Karmic Lifesciences. According to Saxena, kTrials cost about one third of standard EDC and CTMS systems in the market.

Karmic has built its differentiation plank across two key differentiators - Science and Technology. The latter is represented by kSuitetm. Karmic has made a mark in the science domain - Oncology to be specific - it has handled several complex Oncology protocols.

While Oncology protocols continue to capture her attention, Saxena decided to look at the issue of data compliance through a Nano card or Nano-Bio-Chip. This is a smart card with a chip that stores information transmits it directly to servers and can be applied for clinical trials. For instance, it can act as a unique patient identifier to unlock EDC or IP Administration devices for entering data or accessing the drug. It has applications in diagnostics, wherein it can store data and transmit the same to the server.

The nano-bio-chip stores data, is wireless enabled and can transmit near real-time data to the servers which can then be analyzed. Nano-Bio-Chip sensors are further biochemically programmable that offer diagnostic utility and can be applied in multiple scenarios for recording patient vital data e.g. as a Glucometer or Cardiac Monitor.

The way it helps with data compliance is that the data is directly transmitted from the Source to the Server and hence it is virtually impossible to tamper or manipulate the data, which ensures that clinical data is of the highest possible integrity.

How does it function, in simple terms? "We are making it easy as there is no data entry required for all parameters that are digitally captured and transmitted to the server, especially diagnostic and lab parameters. Data entry load is reduced by almost 50%-60%," she explained and added, "We have been involved in pilot projects using such devices for Cardiac or Sugar Blood Glucose Monitoring."

To take things forward, Karmic has tailored an Online Learning Management Portal titled KarmaGyanTM. Built on Moodle open source technology, the system enables Karmic to train its global project management and monitoring staff using a simple web-based interface.

Cloud computing has been leveraged to simplify many of the IT and Clinical Data Management processes in a cost effective manner. Relevance Labs, a Bangalore-based enterprise manages many of the IT solutions.

What is interesting is that Saxena is a first generation woman entrepreneur, who has built a diverse customer base of global pharmaceutical and biotechnology companies and scalable clinical operations and data management group in India. This has ensured a four-fold revenue increase in 2011.

Naturally, it's no surprise that Saxena recently became the president of the India chapter of 'Women in Bio', the first chapter outside US. This organization encourages talented women to join the biotech sector.

With a master's degree from a top management school in India, Saxena has been exposed to cross-functional skills as she climbed the corporate ladder in leading companies, before she set out on her own. She felt the best way to leverage the cross-functional exposure in IT and Data Management would be to start a Contract Research Organization. When she set up Karmic Lifesciences, it was almost like a Karmic calling. (Karmic is derived from the word Karma and simply put it means the energy created due to one's deeds in past and present life.)