Info & Opinion
May 21, 2013
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
A second round of Datasci patent troll litigation is gearing up. ClinPage believes at least four firms are scrambling to determine their strategies. Reed Smith lost the Datasci account to Patton Boggs. In addition to clinical trial technology firms, at least two major contract research organizations are dealing with the possibility of litigation over the patent. Firms that have survived or settled Datasci cases include DataLabs, DataTrak, DSG, etrials, Medidata Solutions and Phase Forward.
New England Research Institutes (NERI), a privately held specialty contract research organization (CRO), announced that its statistical analysis on endovascular aneurysm repair contributed to the recent FDA approval of Medtronic stent approval. “NERI’s Biostatistical Group has a strong reputation in the industry. Their scientific integrity and talent is exactly what we were looking for,” said Simona Zannetti, senior director of clinical research at Medtronic. “NERI played a significant role in helping us achieve FDA approval and expanding our aortic stent graft product line.” Here’s the release.
BioImagene, a provider of innovative digital pathology solutions, launched AgilityBio—a contract research organization (CRO). AgilityBio will offer preclinical and clinical services in partnership with well-established Indian CROs. It will provide its clients with a U.S.-based customer liaison team to facilitate management of international projects. It has the advantage of using BioImagene’s web-based digital pathology technology to provide access to image data. Mohan Uttarwar, CEO, BioImagene, said: “AgilityBio will bring about a synergy between cutting-edge digital pathology technologies and India’s vibrant pharmaceutical and CRO industry eager to work with state of the art R&D methods.”
ProTrials Research, a contract research organization, is establishing new internal benchmarks for the experience level of CRO personnel. Nearly 75 percent of the company’s employees are seasoned industry veterans, with ProTrials’ project managers averaging over 17 years’ experience and regional clinical research associates (CRAs) averaging more than 10 years. “During growth periods such as this, it’s difficult to maintain a balance between experienced and inexperienced staff,” explains ProTrials CEO Jodi Andrews. Here’s the release.
Database giant Oracle announced the formation of a new global business unit. “The creation of the Oracle health sciences global business unit signals Oracle’s commitment to this important sector and our focus on delivering value to health sciences organizations by offering them a comprehensive set of capabilities and superior ownership experience,” said Neil de Crescenzo, senior VP and GM, Oracle.
Aris Global, a provider of drug safety and clinical trial management systems, announced that Novo Nordisk, chose Aris’s Register software as its standard for regulatory information management. Register is a web-based regulatory solution that offers a central repository for managing the tracking of product registration details and submissions. “We are very excited about Novo Nordisk’s implementation of Register for managing their product portfolios and regulatory affairs activity on a global basis,” added Tamir Sigal, product marketing manager at Aris Global.
Octagon Research Solutions, a provider of breakthrough software and services to the life sciences industry, announced a new service, CheckPoint. It provides over 300 separate validation checks of electronic clinical study data to ensure compliance with the Clinical Data Interchange Standards Consortium (CDISC) SDTM (Study Data Tabulation Model). “Electronic submissions enable agency reviewers to navigate to supporting data more quickly and efficiently,” noted Dave Evans, CIO, Octagon. “Compliance is key to a successful electronic submission. We want to give our clients the visibility into data compliance issues before they submit,” he added.