Briefs

BioStorage Lands New Financing

BioStorage Technologies (BST), a provider of advanced biomaterial storage, inventory management and cold chain logistics for the global biopharmaceutical market, last week said it had secured a $5 million Series A financing (including conversion of outstanding notes) led by Radius Ventures and joined by returning investor Twilight Venture Partners.

In connection with the Radius investment, George M. Milne and Arthur H. Spiegel III have joined the BST board of directors.

Milne is a venture partner at Radius and the former executive vice president of Research and Development at Pfizer, where he also served as president of Worldwide Strategic and Operations Management.

Spiegel is a member of Radius’ advisory board. He is the former president of CSC Healthcare, which delivers management consulting, systems integration, full-service IT outsourcing, and claims processing systems and services to the life sciences, health plan and provider markets. Previously, Spiegel was founder and president of APM, the nation’s largest management consulting firm dedicated exclusively to the healthcare industry.

Among BioStorage’s products is a proprietary 21 CFR Part 11 sample inventory management system designed specifically for compliant biomaterial storage, tracking and reporting.

NetRegulus Announces Enhancements

NetRegulus, a provider of enterprise compliance software for regulated industries, last week announced enhancements to its NetRM study solutions.

Enhancements to the workflow capabilities include seven new pre-configured study workflows that enable users to easily keep track of tasks and alerts that impact their specific roles within a study. The NetRegulus workflow engine allows companies to tailor existing workflows or create additional workflow steps, thereby allowing the solution to be configured to specific business or study needs without requiring customization, the company said.

In addition to these new capabilities, NetRegulus announced a number of other enhancements to its study solution, including an improved dual data entry verification process flow for paper-based studies that includes rapid verification of tabular data.

A specific clarification workflow has also been added to support either paper-based or electronic clarifications. This approach ensures that data clarifications are processed efficiently and that dependent processes are not closed until clarifications are completed.

MasterControl Rolls Out New Solution

MasterControl, a software provider for companies in FDA and ISO environments, last week introduced a solution that automates and manages the process for controlling and handling nonconforming materials, the company said.

For regulated companies, conformance to approved materials and components is key to ensuring product quality and safety. The FDA’s current good manufacturing practice regulations, ISO 9001, ISO 13485 and ISO 14001 all require manufacturers to establish and maintain procedures for the disposition of products that don’t conform to specified requirements.

Under these regulations and standards, the nonconformance disposition process is an integral part of the quality management system — and an essential part of compliance.

MasterControl Nonconformance is a configurable solution designed to automate, manage and streamline the process for identifying, evaluating, reviewing and handling nonconformance incidents. As part of its integrated quality management suite, this application connects the nonconformance procedure to other quality processes (corrective and preventive actions, training and change control) under a single Web-based platform.

In addition, MasterControl provides a time-stamped audit trail, reporting and electronic signature capabilities that fully satisfy the FDA’s 21 CFR Part 11 requirements.

Octagon Adds Consultants

Octagon Research Solutions, a company engaged in the electronic transformation of clinical R&D in the life sciences industry, announced the appointments of Mary Lenzen and Frederick Wood as principal consultants in Octagon’s Clinical Data Strategies division.

In their new roles, Lenzen and Wood will oversee Clinical Data Interchange Standards Consortium (CDISC) training initiatives and head the company’s efforts to continue building on its leadership position in CDISC conversions and training, the company said Aug. 1.

Octagon is a corporate sponsor of CDISC, a collaborative working group made up of representatives from industry and the FDA. CDISC’s mission is to lead the development and support of global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.