The FDA is relaxing its guidance for computer systems in computer trials. 21 CFR Part 11 enforcement will be more “discretionary.” We’ll be writing more about this. For now, here is an excerpt from the new document: “This guidance finalizes the draft guidance for industry entitled Computerized Systems Used in Clinical Trials, dated September 2004 and supplements the guidance for industry entitled Part 11, Electronic Records; Electronic Signatures—Scope and Application (Scope and Application Guidance), dated August 2003. The Scope and Application Guidance clarified that the Agency intends to interpret the scope of part 11 narrowly and to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying. However, other Part 11 provisions remain in effect.”

Hutchinson Clinic recently announced that it has selected TouchWorks Electronic Health Record (EHR) and Practice Management (PM) solution from Allscripts to automate and connect its clinical and administrative processes. Allscripts is a provider of clinical software, connectivity and information solutions. Hutchinson Clinic plans to offer the Allscripts solution to smaller physician groups in Central Kansas via a Medical Service Organization (MSO) model. The Clinic would host the solution and offer technical support to the smaller groups in return for a monthly or annual fee.

The Boston e-diary company PHT has entered into a partnership with Mebix, a provider of evidence based medicine monitoring solutions in Japan. Mebix will provide PHT with sales support, project management services and study monitoring at the local level. PHT already has four trial projects through the Mebix partnership. PHT will be able to further enhance and advance the ePRO experience for Japanese biopharmaceutical companies. With this partnership, PHT is strengthening its position as the ePRO vendor of choice in the Asia-Pacific region.

Synchron Research has acquired an India-based CRO, Innovance. Innovance has built a clinical research facility at Ahmedabad. This acquisition has provided Synchron an edge in offering an excellent internationally accepted clinical research facility. The deal was facilitated by Deloitte. “Synchron is looking for more important acquisitions in India and other parts of Asia in [the]future to increase our Asian foot-print to provide more research offerings to our clients” said Dr. Shivprakash, chairman and managing director of Synchron.

A China-based pharmaceutical company Novamed is planning to facilitate clinical development work in China, India and South Africa. In order to fulfill the plan the company is seeking to secure the services of a professional India-based CRO, Veeda Clinical Research, with offices and facilities in the UK and India. According to the proposed agreement, Veeda will allow Novamed to seek development projects from Japan, the U.S. and Europe, which in turn will be delivered through Novamed’s development network in India, China and South Africa.

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