The pharmaceutical and life sciences industry has always been data-centric, especially when it comes to the three major dimensions of a drug product – safety, efficacy and quality. Clinical trials data focuses on efficacy and safety while chemistry, manufacturing and controls focus on the quality of the product – how it is made, packaged, shipped, etc. Over the last decade, cost pressures and the need to improve efficiencies led the industry to realize that data is a corporate asset.  The industry embraced the importance of collecting data, curating it and exploiting it in more meaningful ways across the entire value chain, not just a few functional areas. Now, there is greater focus on master data, data governance, data quality, integration of data, etc.

We've been serving the pharma and life sciences industry with business solutions for over a decade.  We help companies harness data in impactful ways to achieve business outcomes. We provide software solutions and services in areas that have traditionally been slow to exploit the power of data.  We believe effective information management is the foundation to accelerate product launches to global markets. We enable life sciences companies to be more competitive, efficient, and compliant through our products, strategic advisory, and implementation services. We help across four key areas:

  • Regulatory: We understand the data and information needs of the entire regulatory function. We have provided process and systems solutions for several clients by streamlining existing Regulatory Information Management (RIM) processes, designing new processes and enabling them with end-to-end technology solutions. We have a special focus on RIM solutions, including ReALM® for Regulatory Intelligence, which has been an unmet need in the industry. We are partners with major software vendors, such as Veeva around Veeva Vault RIM, Opentext/Documentum, Microsoft, etc., and we are thought leaders at the DIA in defining the scope of RIM and developing the RIM Reference Model as a set of core capabilities for the industry to adhere to.

  • Quality: We understand the data and information needs of the entire quality function. We have provided process and systems solutions for several clients by streamlining existing Quality Management processes, designing new processes and enabling them with end-to-end technology solutions. We have a special focus on Quality Management Systems (QMS) and solutions on Veeva QMS and Trackwise. We are partners with Veeva QMS.

  • Clinical/Safety: Clinical trials are becoming more complex in that they require integration of multiple data sources for better planning and execution of trials and collecting/curating data. We have enabled the integration of data across the clinical value chain to get better visibility into effective planning of trials and analytics of clinical data from trials. We have shown the effectiveness of AI/ML techniques to generate patient safety narratives and clinical study reports. We are partners with the leading Natural Language Generation provider Yseop.

  • Digital Health: With data becoming the currency of operations across the life sciences value chain, there is greater need to harness the power of data using digital transformation techniques, such as AI/ML, to generate greater insights, be it for drug discovery, identifying markets, or generating revenues.


Any major digital transformation initiative requires carrying a multitude of stakeholders across the transformation journey, so there is increased adoption of new processes and systems. We believe strong change management initiatives are important right from the beginning of such transformation initiatives and during implementation and post deployment of new systems and processes. It is important to be engaged with end users to ensure continued use and adoption of new tools.

In addition, data quality and data governance processes are important for data utilization to make better decisions and improve efficiencies. We are well versed in data unification using platforms such as Tamr and master data implementations, especially as companies get ready for IDMP implementation.
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