SEC Associates, a regulatory consultancy, announced it has completed a three-day workshop to train the FDA on the intricacies of electronic clinical trials. In addition to describing basic functionality of core systems used in clinical trials, specific attention was given to how these systems are designed, tested, maintained and integrated by the pharmaceutical, biotech and medical device industries to ensure patient safety and data trustworthiness. The workshop was especially timely with FDA’s issuance in May 2007 of the FDA’s own “Guidance for Industry: Computerized Systems Used in Clinical Investigations.” SEC Associates’ press release notes the agency was especially interested in where the key risks and vulnerabilities reside within the many types of computer systems used in human clinical trials.

Cytel, a provider of statistical services and software, and Tourtellotte Solutions, a drug supply managment software concern, announced the integration of Cytel’s DoseSim adaptive trial simulator and Tourtellotte’s tcVisualize clinical trial simulator. The resulting combination will be a novel development to companies considering adaptive clinical trials, where estimation of drug supply can be complex. “The risk of drug stock-outs and supply overage in adaptive trials is highly significant,” said Ranganath Nayak, CEO of Cytel. We’ve asked the companies for more details.

New England Research Institutes (NERI), a privately held specialty contract research organization (CRO), showcased its expanded clinical trial services at this year’s 43rd Annual Drug Information Association (DIA) Meeting in Atlanta. NERI has added new businesses and increased its employee head count, in addition to its ongoing research studies for private and public sector clients, and also establishing a new “Center of Excellence”. NERI has received several new patient registry and clinical trial accounts for endocrinology and cardiovascular diseases. The company has created and filled 60 new positions, including principle scientists, project directors, data management professionals, clinical research associates, statisticians, epidemiologists and programmers. “NERI has established best practices for operating patient registries,” said President Sonja McKinlay, Ph.D. The organization’s proprietary ADEPT EDC system has recently incorporated real-time benchmarking reports for its outcome registries.

Pharsight, a provider of software and strategic services for optimizing clinical drug development, announced the release of the Drug Model Explorer (DMX) version 1.6. DMX is a web-based and desktop software tool that allows clinical drug development teams to quickly and efficiently explore the modelled efficacy, safety, and other performance attributes of a new drug versus competing therapies. The new release supports improved visualizations of predicted drug performance against user-defined target measures of clinical safety and efficacy that collectively define a product profile. “DMX’s intuitive presentation of model-based product profiles is especially powerful when a new drug faces tough competition,” said Shawn O’Connor, president, chief executive officer and chairman of Pharsight. “The new release makes competitive product profiles a central aspect of the interface so drug development teams and decision makers can interact with model-based results in a familiar context.”

The MathWorks, a developer of technical computing and model-based design software, announced that Merrimack Pharmaceuticals is using SimBiology to streamline the research and development of therapeutics to treat autoimmune disease and cancer. SimBiology plays an important role in Merrimack’s network biology discovery platform, which is multidisciplinary, integrating computational tools from engineering and high throughput biology to rationally guide drug design and development. Birgit Schoeberl, director of Network Biology at Merrimack Pharmaceuticals said, “SimBiology and other MathWorks tools have been instrumental in giving us the competitive edge we need, delivering a combination of powerful mathematics and an easy-to-use graphical interface that makes it easy to create and share models of pathways with other teams throughout each stage of research and development.”

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