DIA Round-Up

Applied Clinical Trials

If you didn’t have a chance to attend the DIA annual meeting two weeks ago in Washington, DC, or were too busy to read the myriad of press releases that came out of the event, or if you need a diversion from your to-do list, this summary of news should prove helpful. It’s in alpha order by company, under the general categories of Technology and CROs.

Technology/SoftwareBBK Worldwide, a patient recruitment company, announced the iPad will support its Franchise e-Binder level processes for subject recruitment and management. Under the various Binders, relevant audiences can access necessary forms or processes, ie., the Study Manager e-Binder offers access to inclusion/exclusion criteria, patient/subject materials, and other forms.

BioClinica has incorporated the Metrics Champion Consortium’s (MCC) Clinical Trial Performance Metrics into its reporting system, which allows sponsors and CROs to “share a common view of clinical trial performance across studies.” The metrics include patient retention, generation of query to update of query response, CRF Pages received/scanned to data entry complete, site productivity and more. BioClinica also demonstrated how its eClinical Technology Suite integrates with Microsoft’s Office and SharePoint platforms.

Firecrest demonstrated its Firecrest Clinical, which bridges education and investigative site performance in a unique Web-based platform. Firecrest Clinical is licensed by the sponsor or CRO for its sites to use in a Web portal. From the portal, the investigators and study team can learn more about protocols, forms, and all the site tasks required for the study in a visual, language appropriate program. The solution has already been a part of over 160 studies in 60 countries.

Medidata Solutions unveiled Balance, its new randomization and trial supply management solution for clinical research sponsors and sites, and can be integrated with its EDC CDM product Rave. Medidata co-founders President Glen de Vries and CEO Tarek Sherif, also received that week the Ernst & Young Entrepreneur of the Year award for 2010 for the Metro New York area. The award makes the duo eligible to receive the national award in November. Sherif and de Vries were chosen for their technology and business vision, notwithstanding facing a recession while taking their company through an IPO last year.

Nextrials’ Prism clinical trial data management platform is available for the iPad, and as an iPhone app, available on iTunes for free download later this year.

Pegasystems met with Applied Clinical Trials to discuss its rules-engine based business process management platform that integrate data out of the silos and into cloud computing for greater use and transparency. The life sciences team is comprised of ex-Adobe execs, who de-camped in January this year to provide the push needed for large CROs and pharma.

PharmaVigilant announced its new CRO Partners Program, inviting CROs to offer their sponsor clients’ access to PharmaVigilant’s suite of technology that includes EDC, data warehousing, study building, Electronic Trial Master system, remote Source Document Verification, study administration, and an automated site payment system. Partners are receive access to training and branded marketing materials.

Qumas also announced that its compliance solutions are integrated with Microsoft’s SharePoint platform.

Virtify positioned itself to address the myriad complexities surrounding FDAAA’s clinical trials disclosure requirements by announcing that Clinical Trials Registration & Results (CTRR) Enterprise 2.0 will be available in Q3 2010 as part of the company’s Enterprise Content Compliance software suite. CTRR addresses and automates U.S. disclosure rules, as well as moving forward to address emerging global registry requirements include EudraCT in Q1 orQ2 2011, Brazil, India, Germany, China and more.

CROs
ICON
announced it was one of two CROs that were selected by Bristol-Myers Squibb to provide global support for BMS’ clinical development program. The three-year agreement covers the entire pipeline. BMS chose this strategy because of its robust pipeline and significant inlicensing activity, requiring a large volume of clinical development work and expanding upon existing partnering approaches, which in ICON’s case is 10-year long relationship.

InveSci http://www.invesci.com debuted its CRO services, which cover a broad range of the clinical trials spectrum, and through to post-marketing and risk management strategies. InveSci, a recently formed full-service CRO, is finding great opportunities in providing high quality service and forming partnerships with sponsors and other service providers both within the U.S. and globally.

Parexel announced it was selected by Bristol-Myers Squibb to provide global support for BMS’ clinical development program. The three-year agreement covers the entire pipeline. BMS chose this strategy because of its robust pipeline and significant inlicensing activity, requiring a large volume of clinical development work and expanding upon existing partnering approaches. Parexel COO Mark Goldberg, MD, told Applied Clinical Trials that the agreement is an example of what is occurring the sponsor space, where companies are looking for more strategic opportunities to get away from former partnering agreements such as preferred providers and traditional RFP processes. “The benefits of working collaboratively give the company the opportunity to invest in partnerships, in the business processes, the technology and to find real benefits in reduced cycle times,” said Goldberg. And with the ability to eliminate fixed costs, pharmaceutical sponsors are outsourcing an increased number of their studies explained Goldberg. Phlexglobal is expanding into the United States, opening its first office outside Europe in Carlsbad, CA. Aidan Nuttall, PhD, is the U.S. office president whose experience includes co-founder and president of Abingdon Life Sciences, and former president of Chiltern’s U.S. operations.

Quintiles released its report “A Survey of Biopharmaceutical Stakeholders in The New Health,” which looks at the points of view of healthcare, drug development and drugs from the unique perspectives of biopharma executives, managed care executives and patients. The survey is available at Quintiles Web site here http://www.quintiles.com/newhealth/report/

United BioSource (UBC) announced expansion of its clinical research and medical affairs capabilities in Europe by opening an office in Lorrach, Germany. This office is near UBC’s Basel, Switzerland office and is the 10th UBC office in Europe, which has locations in the UK, Ukraine, Spain, Sweden, Hungary and the Czech Republic.