August 8, 2007 | Pounding the pavement at the Drug Industry Association (DIA) annual meeting in Atlanta at the Georgia World Congress Center, Bio•IT World found a number of chatty souls who shared their comments, observations, and announcements about the the meeting’s hot trends. Some of this year’s key themes are technology integration, greater focus on drug safety, and globalization of clinical trials.
TECHNOLOGY
Richard Piazza, vice president product strategy, etrials: “Right now, integration is very big. At DIA, we’re introducing our next generation eClinical solution, EDC 2.0, which integrates with our eDiary and IVRS and IWRS in real-time. We’re also looking at other data that we could capture and integrate such as data from blood glucose meters and maybe spirometers because we think there are applications for our technologies and processes beyond clinical trials.”
Brent Shepherd, vice president sales, TranSenda: “We’re officially launching our clinical trial management system (CTMS) designed for small- to mid-sized life sciences companies. Our CTMS product is part of the Trial Management Package, which will also consist of the CTMS Dashboard, plus the Payment Tracking Manager. These modules will be available in late Q3 or early Q4. These are integrated modular software solutions that use our Clinical Trial Process Manager platform. The industry is moving toward integrated solutions.”
Robert Quinn, senior product marketing manager, Phase Forward: “We have just released Central Designer, which will enable companies to streamline the processes they use to build EDC studies. Central Designer addresses the front end issues around getting the trial up and running in the first place. One of the challenges for sponsors is that it takes too long to build studies, and about 70% of the build time is spent on incorporating logic to improve data and trial quality, and then checking it after it’s done. People here are looking for solutions to these challenges.”
Alana Vantege, director, business development, BLCPro: “It was great to see so many companies marrying technological advancements with clinical/data management expertise. We now have more in-depth solutions with respect to adaptive trials design and data management solutions. Some of the highlights were: OmniComm just completing the integration of its EDC solution with Oracle Clinical; CRF Inc. offering comprehensive ePro solutions; Medidata offering impressive EDC solutions; Waban Software providing great tools for data handling, tracking and analysis, and many others.”
Beth Harper, president, Clinical Performance Partners: “I see the industry’s focus shifting from merely tracking site performance to predicting site performance, and the industry is seeking new tools to aid in this process. Operational modeling and simulation tools can leverage existing CTMS and EDC data to diagnose study performance problems, enable real-time ‘what if’ scenario planning, and provide cost/benefit tradeoff simulations based on recommended interventions. One of the emerging solutions, the PharmaLenz platform, provides a user interface, analytic platform and knowledge base.”
SAFETY
Cindy Kimchi, vice president business solutions, ProSanos Corp.: “We are launching CLÆRITY, a next-generation data mining product that detects safety signals, investigates signals of interest, and generates results in seconds. At DIA, we have access to industry leaders in safety and pharmacovigilance. Our technology is very cutting edge and DIA is a great forum for us to introduce it.”
GLOBAL TRIALS
Richard Leach, vice president, Global Clinical Trials in Russia and Eastern Europe: “There are people here with some serious needs, and the interest level in Eastern Europe and Russia is unlike what we’ve seen in previous years. It’s because the large pharma and CROs were the first to branch out over there, and a lot of the smaller pharma and biotechs are starting to feel comfortable with those areas.”
Venkatraman Sunder, vice president, operations, Asian Clinical Trials (India): “DIA is the best forum to promote India and ourselves. Last year in Philadelphia, there were more questions about conducting trials in India. This year, we are promoting ourselves. In one year, the number of CROs from India exhibiting here has doubled.”
Laura Luchini, executive director, EuroTrials Brazil: “The networking is better this year. We have two objectives — to improve our knowledge and to meet people from all over the world.”
Jeanne Meadow, senior vice president, Healthcare Communications Group: “One of the trends isn’t something you can see, it’s something you can feel. There’s a lot more energy this year even though the attendance is about the same as last year. There’s more buzz this year.”
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