Info & Opinion
December 13, 2018
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 top industry publisher says several trends point to an improving, quickening climate for clinical activity
Aetna, Covance and GNS Healthcare are joining forces to use so-called big data software tools to create a model of diabetes. In plainer English, they'll mine large numbers of medical records in an effort to link individual health status, prescribed medications and treatment outcomes. "Using data, we will now know very quickly which of these strategies works best for specific members,” said Michael Palmer, the head of Aetna's Innovation Labs. “We will also know where we can make improvements or create new programs to help our members.” Here's the release.
Scrip announced its clinical trial-related awards for 2012. Quintiles took top honors for best contract research organization (CRO); its founder, Dennis Gillings, got the lifetime achievement award. PPD took home the prize for best technological development. Icon won the best Clinical Research Team honor, which was based on ramping the launch of a large Phase III clinical trial at 109 sites in 15 countries within two weeks of receiving a final protocol.
BioClinica reported quarterly financial results. Revenue rose 16 percent, to $24.9 million. Profits jumped 51 percent, to $542,000. Revenues and backlog orders for imaging, randomization and electronic data capture systems were strong. Sanofi recently picked the firm's clinical trial management system.
Merge will offer its eclinical technologies through the EMC Select platform. “EMC will now be able to offer healthcare customers an integrated suite of solutions to share diagnostic content and results,” said Scott Filion, GM of the EMC health care division. “By leveraging a standards-based approach and using web-based technologies, iConnect enables health information exchange to lower costs and enhance patient care.”
This wire service article outlines competing vaccine, drug and, yes, human excrement-based therapies. All of the treatments are being targeted for the three million U.S. patients who annually wrestle with clostridium difficile infections that flourish after antibiotics kill most friendly bacteria in the bowels. The article suggests many doctors are more excited about stool-based transplants than pharmaceutical techniques, chiefly because the results can bring dramatic and immediate relief to patients.
Vista Equity Partners has sold a portion of its shares in Medidata Solutions, the industry's largest independent provider of clinical trial software. The San Francisco investors didn't disclose any reason for the sale. Vista began putting money into Medidata during October, 2011 and still owns slightly less than five percent of the firm. Here is a relevant SEC filing.
GSK said it intends to grant outsiders access to some patient-level datasets that most of the industry considers proprietary. It's not clear whether competitor firms or academic physicians would be able to troll the company's data, as the big UK firm will pick and choose who gets access. Said GSK: "This will enable researchers to examine the data more closely or to combine data from different studies in order to conduct further research, to learn more about how medicines work in different patient populations and to help optimize the use of medicines with the aim of improving patient care." Here's the release. In a related development, GSK is also participating in the TransCelerate consortium which intends to create metrics and data standards building on tools shared across both industry and academic research landscapes.