Small Companies Face Unique Electronic Information Challenges, Expert Says
While drug and device firms know they need to manage their intellectual property electronically, they also face ongoing business and operational challenges around regulatory, quality and project management needs, according to an expert.
More companies are beginning to address business and compliance demands in one modular, configurable and cost-effective application, says Rita Geiger, president of InfoStrength.
After conducting detailed interviews with CEOs and executives of operations, quality assurance and regulatory departments at more than 65 large and small life science companies, Geiger said those professionals view their primary purpose as helping to create, distribute, apply and share knowledge. "It constitutes the intellectual property (IP) of their company and they recognize its value," she told PIR last week.
"The inability to effectively manage critical information and the potential loss of IP directly and negatively affects the financial health of a company," she said. For smaller companies, this loss means the very sustainability of their business is threatened, Geiger said.
"Our discussions with company experts confirmed that these smaller companies had the same critical business needs as the large companies independent of whether the company was a biotech, device firm or a consultancy to a life sciences organization," she said. "Unfortunately, the solutions adapted by large companies could not scale down to match the limited availability of IT expertise, implementation dollars or other resources most smaller organizations suffer from," according to respondents, she said.
Among the results of Geiger's industry interviews:
For companies of all sizes, project execution and business strategy are not always well aligned. "For example, it is not always clear to the scientist in the lab what deadlines, objectives or other promises his CEO or other executives have made to their investors or regulatory agencies," she said. The most common types of communication that smaller companies encounter are periodic face-to-face meetings, quick emails or conversations at the water cooler. Ineffective decisionmaking processes are evident in any organization where information is not readily available. "In smaller companies, project management is viewed as a luxury item and, in many cases, if a company is lucky enough to dedicate a part-time or full-time [project manager], this talented individual inefficiently spends [his or her] time moving from desk to desk collecting input about project timelines, milestones and deliverables," she said. "Critical decisions are made on gut feel instead of a collaborative effort of the project or executive team." Drug and device projects require multidisciplinary teams that consist of part-time or full-time scientists, engineers, quality and regulatory experts, as well as executives and business development people who may come and go throughout the lifecycle of the project.
"These projects are not just a set of tasks and milestones," Geiger said. They are collaborative processes that require decisionmakers at different intervals. These limited company project managers must manage multiple challenges in a dynamic environment and maintain an audit trail at the same time. On top of that, they must manage critical documents that hold the company's IP and evolve through multiple versions. Essential elements of these projects also include company and project-specific SOPs, communications and other resources.
To address these and other issues, InfoStrength has launched its InfoStrength Smart Enterprise Suite (InfoStrength SES). It is the first "smart enterprise suite" application designed for small to midsized life science companies. The product offers one validation-ready solution that is combined with business-critical functionality, traditionally found scattered across organizations or departments in multiple nonintegrated applications, according to Geiger. InfoStrength SES brings together extensive process and project management, quality and regulatory compliance management, and collaboration management into one secure application. "It is modular and easily configured without the need of IT expertise to meet specific operational needs," Geiger said.
InfoStrength SES helps companies to understand and control the activities of their organizations and ensure that policies and procedures are adhered to, Geiger said. This ability, in turn, creates greater confidence and a more organized and professional collaborative infrastructure. -- Michael Causey