Q1: Could you explain what Sciformix does and what your role is within the corporation?
Sciformix Corporation is a leading scientific process organization (SPO) that partners with life science companies to develop, launch and sustain medical products that aim to improve the quality of healthcare worldwide. We collaborate with our clients through the entire product development lifecycle to provide a full range of services from study design to post marketing surveillance and commercialization support – in the areas of Safety and Risk Management, Clinical Research and Regulatory Affairs. In short, we are a partner to pharmaceutical companies in managing key scientific processes.
As Co-founder and Executive Chairman, my role is to provide strategic direction, manage major client relationships, and work closely with my senior management colleagues in helping drive key areas of business.
Q2: What are the challenges and opportunities with respect to technology and innovation in your market?
The Pharma industry is generally slower in adopting new technologies given the regulatory nature of the business. Existing technologies and tools in the areas we serve focus on the capture and management of data relating to scientific processes. They do not go far enough to make a meaningful impact on compliance, quality, and productivity, which are key drivers for clients. Therein lies the opportunity.
Let me share with you a real example in Pharma. Over the years, the role of pharmacovigilance or Product Vigilance (PV) has changed from capturing and reporting adverse events to a business imperative responsible for risk assessment, risk management, and risk mitigation. It is an essential element to every pharma company’s strategy. Implementing best practices in the area of patient safety and regulatory compliance strategy is the fine interplay between domain knowledge, streamlined processes, and technology innovation. Sciformix has done just that. By adapting a client’s processes and standardizing their sub-processes through a LEAN paradigm and by creating an automation layer that seamlessly traverses the information silos, we can ensure compliance while optimizing requirements of all types of resources. By making the process nimble, we can focus on producing homogenous results which conform to compliance, productivity, and quality under different environments.
We have developed an overarching automation layer, SciVigilance™, which can be easily applied to any PV process of any client. We realized at the outset that such automation encapsulating PV operations would have to work without any changes of codes in the underlying call center, case processing, and allied systems already in use and minimalistic changes to the operational SOPs. Thus we built an agnostic system based on robust technology with a three tier architecture that is highly configurable and customizable, and enables LEAN processes to be implemented without changing the code base. SciVigilance allows the client to continue working seamlessly across multiple underlying safety applications (databases and tools). SciVigilance is an automation layer which integrates proactive case management, quality management, and project management of PV process into a compliant and structurally validated system with inherent traceability and audit trail. It supports effectiveness in case management through active tracking, strategic alerts, and notifications that allows personnel to focus on core business objectives.
Q3: How does Sciformix employ technology and innovation to achieve excellence in outsourcing services for clients? (Do you deploy traditional technology in innovative ways or focus on providing new, technologically innovative products?)
We are taking a rational approach in adopting new technologies and towards our investment in building innovative products. We are expert users of existing technologies and are best suited to identify solution gaps in the market we serve – specifically life science. Our solutions are addressing these gaps while bringing in new levels of innovation to benefit our clients. Because of our rich knowledge and expertise, we are able to introduce the notion of lean processes and technologies that simplify workflows and automate tasks. We are offering “technology enabled services” as well as “technology as a service”. We deploy existing technologies in ways that maximize their potential, while building innovative products that interface with existing technologies to deliver measurable compliance, quality, and productivity benefits to the scientific processes we execute for our clients.
An example of how Sciformix is employing technology to achieve excellence in outsourcing services for clients can be demonstrated on our recent launch of Scignal Plus™. Scignal Plus provides superior, efficient signal detection of Adverse Events by incorporating computational algorithms for a new method of signal detection that was developed by the US FDA which has several distinct and important advantages over other products that are available in the market. It is a standalone web-based tool which employs a user-friendly interface for navigation and informative graphical displays.
Q4: In what ways does this benefit your clients?
The technologies and tools we are building and adopting are becoming an integral part of our service offerings. In turn, our clients have begun experiencing meaningful outcomes in areas of compliance, quality, and productivity.
An example of this can be demonstrated with SciLabel Pro™ - the engine behind our labelling automation services. Pharmaceutical product labeling is a highly regulated and complex process. “Product labeling” is a generic nomenclature that includes the actual label on the product, the package insert, and labels on any packaging material. Each label update involves input from multiple stakeholders like regulatory, legal, quality, and manufacturing personnel. The sheer number of reviews makes data management, version control, and audit trails prerequisites for the labeling process. Most organizations utilize key resources to do a side-by-side comparison of the two documents and implement the differences between the two documents, which is labor-intensive and error-prone. Sciformix SciLabel Pro™ automatically highlights the differences between the documents. The result is a significant reduction (in many cases >50%) in cost and delivery time with the added benefit of improved quality. This is due to the steep reduction of human intervention since the update process is automated.
Q5: How is Sciformix set up to adapt new, innovative technology to keep you ahead of your competitors?
Key members of Sciformix’s management team have a proven track record of delivering successful technologies and products to the pharmaceutical as well as managing large technology initiatives. An example from my past is NuGenesis SDMS. NuGenesis is currently the gold standard in scientific data management within pharmaceutical laboratories. Sciformix has the expertise, investment, and overwhelming client support in these efforts. We are adopting and delivering on these technologies in partnership with large pharmaceutical companies.
Ajit Nagral, Executive Chairman – Biography
Ajit Nagral is a serial entrepreneur who has built multiple companies in the Life Science and Technology domain that have generated hundreds of millions of dollars in revenue over their lifetime. Mr. Nagral has created sustainable market brands that continue to lead, innovate and deliver critical value to the pharmaceutical and biotechnology industries. In 2007, Mr. Nagral co-founded Sciformix Corporation and is currently its Executive Chairman. Prior to Sciformix, Mr. Nagral founded NuGenesis Technologies Corporation, a company that became a worldwide leader in Scientific Data Management and was acquired by Waters Corporation (NYSE: WAT) a multi-billion dollar Life Science company. Prior to NuGenesis, Mr. Nagral founded Megaware, Inc. in 1991, a critical provider of Software and IT Services to the Life Science industry. Mr. Nagral is a Charter Member of TiE (The Indus Entrepreneurs) and served on the Board of Trustees of TiE Mumbai. Mr. Nagral is an active investor and advisor to several startups.
About Sciformix
Sciformix Corporation is a world leading Scientific Process Organization (SPO), providing scientific knowledge-based services to pharmaceutical and biopharmaceutical, generics, consumer products, medical devices and other healthcare companies - in the areas of Safety and Risk Management, Clinical Research & Post-Approval Support and Regulatory Affairs. Our mission is to partner with global life science companies to provide high quality scientific knowledge-based expertise to deliver better quality outcomes and improved efficiencies across the entire product lifecycle with the ultimate objective of improving quality of healthcare for patients worldwide. Corporate headquarters is located in Westborough, MA with operations in USA, India and the Philippines.
We create value for our clients through our singular focus on the life sciences industry, strong pharmaceutical domain competency, exceptional subject matter expertise, industry reputed scientific advisory board, uncompromising focus on quality, process rigor, predictable results, and ability to scale. Our portfolio of services spans the full spectrum of product lifecycle from preclinical and clinical to post marketing activities to help our customers solve complex analytical challenges, improve the quality of patient healthcare and increase client productivity.
Sciformix is dedicated to providing our clients with outstanding services and solutions, fueled by an unrivaled commitment to quality. We share the same level of involvement, dedication and passion as our clients by becoming an integral part of their team. Our distinct combination of scientific expertise, process rigor and technology innovation delivers consistent, reliable and insightful results. Our ability to scale and grow to meet your evolving needs means we are flexible and dedicated to your success in delivering safe products with more efficiency and greater speed. We help you make the right decisions at the right time by providing Trusted Services Built on Science.