DSG, a supporter of clinical trial data collection for the pharmaceutical and life sciences industries, recently announced a partnership with Solomon Group (SGL), a Taiwan-based contract research organization (CRO). The two companies will offer comprehensive electronic data capture (EDC) and data management services to the life sciences industry in the…more...

Icon, a contract research organization, has recently announced that it has set up a dedicated business group within its clinical research division focused on observational research and analysis services. The new group will incorporate Ovation Research Group, a patient registries, outcomes research and health economics firm that was acquired by…more...

We don’t hear much about gene therapy any more. But Research Dynamics Consulting Group, a specialty contract research organization (CRO) in Pittsford, NY, announced that it had been awarded a major contract for a multicenter Phase II gene therapy trial by an unidentified biotechnology sponsor. The trial will proceed at…more...

Random Technologies, the newest start-up company to emerge from the University of Rochester Medical Center (URMC), launched its statistical analysis software package at an international conference of drug industry professionals last week. Random Technologies’ RPro Statistical Software is based on the open source software system ‘R’—the most widely used statistical…more...

Key senators have agreed on the shape of legislation allowing biosimilars, the Wall Street Journal reports. There will be 16 years of patent protection for the original developer of a biotech product. Generic drug companies seeking to copy biotech products will have to run clinical trials, although the FDA will…more...

A key committee in the U.S. House of Representatives passed a weaker version of user fee and drug safety legislation, dropping a requirement for FDA analysis of post-marketing data and avoiding a showdown over tighter rules about promoting drugs after they are launched as products. The legislation would mandate a…more...

INC Research, a contract research organization (CRO), has officially implemented its Trusted Process in all of its current clinical trial programs. The Trusted Process is a series of phases that proactively lead customers through their drug and device development programs with repeatable and measurable methodology. As a result, INC Research…more...

Phase Forward, a clinical trial suite, recently announced a new submission checking service offering based on its web submission data manager (WebSDM) application. Developed under a cooperative research and development agreement between the FDA and Phase Forward’s Lincoln Technologies safety division, WebSDM gives organizations a means for testing FDA submissions…more...

SAS will facilitate data from health care providers and hospitals in its Drug Development environment for collaborative data analysis. Here’s the announcement. “Strong and efficient interfaces that link electronic health records with the pharmaceutical industry and regulatory authorities will enhance public health by improving both therapeutic product safety and efficacy,”…more...

Symfo, a provider of electronic patient reported outcome (ePRO) solutions for clinical trials, announced that its SymPhone eDiary is now equipped for wireless or landline data transfers. The SymPhone now offers sponsors the flexible solution of letting patients send data either through wireless (GSM) or landline (IDR) technology, whichever is…more...