Xybion Corporation
Providing Interconnected Technology Enabled Solutions for Life Sciences, and other Highly Regulated Industries

"After working with a large number of global life sciences companies in strategy, process and technology for the R&D areas, I realized the need for end-to-end software solutions which embeds compliance into the operating processes and systems while lowering the total cost of ownership for global corporations operating in regulated industries. And that is the story behind Xybion Corporation,” begins Pradip K. Banerjee, Chairman, and CEO, Xybion Corporation. Headquartered in Princeton NJ, Xybion is a life sciences R&D and Healthcare IT solutions firm that offers integrated platform for drug safety study management, compliance, quality and risk mitigation, facility management and content migration. Today, the company offers a broad range of services including validation, software testing, implementation, custom application development, business intelligence, project management, training and global support.

“Drug development is a highly regulated process due to its severe regulatory requirements from the FDA and other bodies. Our idea is to help large companies to fast forward their drug development approvals in a systematic way, saving time, cost, and resource,” says Banerjee. “Our system automates the entire business process of safety assessment studies, compliance process of audit, Corrective and Preventive Actions (CAPA), documentation, along with assistance in management, governance, risk, and compliance.” In addition, Xybion also allows their clients to meet the 21 CFR Part 11 requirements for quality assurance.

With a special focus on laboratory management, Banerjee feels that the management and validation of critical documents are the other main challenges that the Life Sciences industry is facing today. “Documentation and validation are time consuming, intensive and costly processes, where every change has to be tested and re-validated. We opened our Indian operations in 2011 from where we carry out the validation process for our clients. In addition, to manage and maintain these documents, we have a technology-enabled content migration solution- Migration Studio,” reveals Banerjee.

The specialty of Xybion lies in its family of software products and deep domain experience that helps clients to integrate solutions to increase operational efficiency, while reducing the total cost of ownership.

Our idea is to help life sciences companies fast forward their drug development approvals in a systematic way saving time, cost, and resource

In other words, “We provide a complete end-toend laboratory management and drug safety solutions, along with the entire compliance features. On average, Xybion saves its customers 20-30 percent on IT hardware, software and maintenance costs,” adds Banerjee. Some of their top clients are Merck, Pfizer, Novartis, Bristol-Myers Squib and Johnson & Johnson, spanning fifteen countries in five continents.

In one instance, a major global pharmaceutical company chose Xybion’s Drug Safety study management system for its global laboratory facilities and de-commissioned 14 different legacy systems to be replaced by Xybion’s integrated Safety, compliance, data warehouse & analytics platform. Both implementation of the new platform and de-commissioning of the legacy systems had to be validated as per FDA’s requirements. The global company now conducts its entire global drug safety R&D studies on Xybion’s platform. Xybion is best positioned to leverage its various solutions, which encompass the entire range of healthcare services, including the Pristima Suite for preclinical, Stelex Enterprise Asset Management, eQCM for quality, Compliance Builder for Risk and Compliance, and Vital Path Suite for content migration. Xybion is truly a “one stop shop” that addresses all of the healthcare industry’s needs. Opening its Global Delivery Center (GDC) in India has helped the company improve deployment times, reduce costs.

Moving ahead, Xybion will continue to provide high quality enterprise software in drug development, governance, risk, and compliance areas in the cloud and in a hosted. “We are also in the process of launching an evidence based healthcare management platform based on treatment guidelines created by various American Colleges of Medicines, which will be a complete SaaS in Cloud,” concludes Banerjee.