At the Drug Information Association’s (DIA) 43rd Annual Meeting, June 17–21, 2007, in Atlanta, GA, experts from Parexel International, a major contract research organization, will present key topics. Dr. Alberto Grignolo, PhD, corporate vice president and general manager of drug development consulting for Parexel and the DIA annual meeting chairperson, will give the meeting’s opening remarks. Attendees will hear him and other Parexel experts discuss issues such as risk management, regulatory compliance, patient enrollment, quality assurance, EU regulations and more.

BBK Worldwide, a clinical trial patient recruitment company, announces the inception of its Global Mobilization Team, a new division specializing in operational strategy, planning, deployment of resources and implementation of large-scale, multinational clinical trial patient recruitment campaigns. The addition prepares the company to better anticipate and fulfill the needs of a clinical development landscape in which longer-term trials, requiring greater numbers of patients, and conducted in dozens of countries, are becoming the norm. BBK’s Global Mobilization Team draws on nearly 25 years of patient recruitment experience and thought leadership, and a cadre of experts and resources from among BBK’s world-class recruitment partners in the BBK Worldwide Alliance.

Fast Track Systems, a Pennsylvania-based provider of clinical cost data and software to improve the clinical trial productivity, announced new products and extensions. The improvements permit sponsors to actively manage investigator site and contract research organization (CRO) contracts. The new products provide a secure browser interface for contracting professionals to analyze past agreements with sites and CROs. Fast Track will let users to evaluate contracts along the following dimensions: protocol number, specific site, individual investigator or CRO, phase, therapeutic area, geography (country, state, zip code) and time period. Custom reports can be generated and archived to readily determine how much has been paid for work activities. Additionally, document retrieval functionality enables related agreements and unique contract provisions to be archived and referenced.

TrialStat, a Canadian electronic data capture (EDC) company, recently announced enhancements to ClinicalAnalytics 4.0. The new features and enhanced capabilities include integrated dictionary management, real-time patient milestone reporting and form re-use. CA already boasts EDC deployment times that are nearly twice as fast as the industry average, thanks to 100% browser-based study configuration tools. The additional features further improve the speed of starting and completing a study.

Quintiles Transnational, with headquarters in North Carolina, announced that its Asia Pacific unit has received three awards for excellence in customer service. Quintiles received the multinational clinical services provider of the year, multinational laboratory services provider of the year and customer service leadership of the year awards at the Frost & Sullivan 2007 Asia Pacific Excellence in Health Care Award Ceremony held June 8 in Singapore. Anand Tharmaratnam, head of Clinical Development, Asia Pacific, and CEO of Quintiles Southeast Asia, attributed the achievement to the company’s commitment to its employees and to its customers.

Green Mountain Logic (GML), located in Montpelier, Vermont, provides Phase I clinical trial software. GML recently announced that the company and Phase Forward, a clinical trial technology suite company, have agreed to work toward developing a future interface between GML’s LabPas CT product and Phase Forward’s InForm ITM electronic data capture (EDC) product. Phase I researchers and pharma/biotech sponsors would benefit greatly from this interface, which would be designed to enable validated Phase I clinical trial data collected with GML’s LabPas CT to be electronically transferred into Phase Forward’s InForm EDC product. This interface is expected to shorten overall Phase I trial times by reducing the number of queries and speeding time to data lock. “We are delighted to have the opportunity to work with an industry leader like Phase Forward. Their reputation for quality, experience and enterprise scalability in the clinical trial arena is unsurpassed,” said John Rosenblum, CEO of Green Mountain Logic, developers of LabPas CT.

Avandia critic Rosemary Johann-Liang, a key FDA staffer, has left the agency for another federal job. The FDA maintains the reasons for Rosemary Johann-Liang’s departure are unclear. Congress is investigating. Here is a quote from Johann-Liang in USA Today: “I really advocate for drug safety, and a lot of times the agency doesn’t want to hear that there are problems. I think, in general, there is a culture of ‘The drug is always innocent.’ ” Johann-Liang’s saga makes it more likely there will be Congressional pressure for a separate agency for drug safety.

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