Cabeus
Transforming Information Management for Regulatory within Life Sciences

Over the past two decades, the Life Sciences industry went through major transformation by streamlining processes and introducing new technologies in order to support strategic business drivers such as speed to market, greater compliance, and increased process efficiencies during the product development and commercialization lifecycle. In the process, many systems and applications were built and deployed which, while satisfying immediate functional needs, became siloed and fragmented over a period of time. In recent years, the business model has changed significantly, such as greater outsourcing, need to launch products simultaneously across the globe and greater scrutiny of product data by health authorities. Hence, this has created the need for unearthing the potential of data that is hidden in siloed applications and providing access to end-to-end information such as data, documents, and analytics, creating greater demand for improved efficiencies across the information management lifecycle.

Founded in 2010, Cabeus is a niche products, solutions and services firm focused on improving information management efficiencies across Regulatory, Safety and Quality functions within Life Sciences. The company provides high-end services around process design, enterprise architecture, data integration through constructs such as web services, master data management and data warehouse, enhancing data quality through data profiling and monitoring approaches and building applications to address specific challenges. In order to help customers be less dependent on their stretched internal resources or shared services, the company has its “Lab-in-the-Cloud” environments where they can easily spin up virtual environments and carry out early development and testing in an iterative fashion, showing interim progress to clients and getting their feedback for ongoing development.

The Regulatory Value Chain in Life Sciences is not sufficiently supported with process and technology capabilities during the early stages of regulatory strategy, planning, and submission phases resulting in major inefficiencies and significant revenue loss. Cabeus’ ReALM Suite of SaaS solution is built on an integrated information architecture to transform the entire regulatory value chain.

With unique triangulation of domain knowledge, strong technology leadership and exceptional delivery skills, Cabeus provides better data and information integration across the regulatory value chain.

The first two modules for Global Regulatory Intelligence and Planning (GRIP) provide a structured and repeatable process to access regulatory guidelines, subject matter interpretations and industry best practices for different types of regulatory activities and enabling detailed submissions planning at a component level.

“Our ReALM Suite is addressing an unmet need within the Regulatory Value Chain and we believe it is going to transform the regulatory strategy and planning processes,” says Dr. V. Bala Balasubramanian, President and CEO, Cabeus. ReALM has the potential to provide end-to-end visibility of regulatory information with an agile, robust, scalable and integrated solution. Going forward, Ravi Krishnamurthy, Vice President and Head of Technology Solutions, says, “As part of our product roadmap, we also have plans to build additional capabilities since we have the right information architecture to support the entire value chain. Also, some of the technology vendors have expressed interest in integrating our solutions with theirs to provide a more holistic set of capabilities.”

As a new standard in the EU called Identification of Medicinal Products (IDMP) is driving the need for end-to-end data integration, Cabeus has formed a consortium with two other companies in Europe to bring an integrated solution to address the emerging challenges of IDMP. This integrated solution addresses the extraction, management, and curation of both structured data from traditional database applications and unstructured data from documents.

As Nishchal Sehgal, Vice President for Client Services adds, “What differentiates us from others is the unique triangulation of domain knowledge combined with strong technology leadership and exceptional delivery skills. We are successful because we are very consultative and advisory going beyond what’s required when it comes to client engagements.”