Over the past few months, I’ve been gathering information on software vendors that address quality data management in the life sciences industries. Related to this effort, I attended a half day presentation by NetRegulus earlier this month.
NetRegulus is one of the more prominent players in this space, which includes dozens of vendors offering solutions for quality management, such as Corrective and Preventive Action (CAPA), complaint tracking, internal and external audit, Six Sigma, non-conformance, and adverse event tracking. Some other well-known vendors in this space include
Pilgrim (SmartSolve, SmartCAPA),
Sparta Systems (Trackwise), and
AssurX (CATSWeb).
NetRegulus, however, covers a broader set of functionality than most vendors. It provides quality and regulatory data management for the production phase of the product life cycle, and it also provides support for the "study" phase, such as management of data for preclinical and clinical studies as well as postmarket and other studies. Study Management functionality includes ability to define study protocols, design and manage case report forms (CRF), define study sites, collect and verify study data, and prepare study data for regulatory submissions and other reporting. The system makes good use of open standards, such as Adobe Acrobat, to collect and manage study data.
The business case for NetRegulus is both tactical and strategic. On the tactical side, the system can reduce cost of studies, cost of compliance, and cost of quality. On the strategic side, the system promises to improve time-to-market through better management of study data. This strategic aspect gives NetRegulus a strong selling point for many life sciences companies, for whom easier and better preparation of FDA submissions and shorter approval cycles translate into faster generation of revenue from new products. Public health and safety is also enhanced if companies use the system to provide better correlation and trending of quality data with integration of complaints or adverse events with study data.
Pricing, however, might be an obstacle to early stage start ups that are accustomed to doing things on the cheap. NetRegulus is a Tier I solution, with pricing starting at about $50,000, for a limited number of user seats. NetRegulus points out, however, that when compared with the cost of outsourcing a single study to a contract research organization (CRO), the cost of the system, which can be used for study after study at no additional charge, begins to look reasonable.
NetRegulus is not alone in addressing requirements for study management.
Phase Forward offers similar functionality, and some major application vendors offer study management as part of their enterprise suites.
Oracle with its Oracle Clinical product and
Siebel with its Siebel Clinical product are two examples.
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. I'm especially interested in hearing about best practices, lessons learned, horror stories, and case studies of success or failure.
