Info & Opinion
July 21, 2019
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
ER Squared, a clinical trial technology consultancy founded by ex-Bayer executive Robert Musterer, has added another employee. John Fontenault will serve the Connecticut firm as VP of operations. ER Squared advises clients about eclinical challenges, software vendors, biostatistics staffing and data management, among other topics. Says Musterer: "I'm very optimistic. Companies are starting to feel a little less pressure from the economy. People are going to start hiring again and expand their projects again."
The U.S. government launched a modest campaign to promote research participation by the public. It's a generic, uncontroversial website, under NIH auspices, perhaps intended to address public skepticism of science in general and the pharmaceutical industry in particular. The site's portrait of clinical research is sanitized, with text borrowed from other federal web efforts. There is no whisper of money as one reason for physicians to participate in industry research.
China is proposing a plan to bolster drug safety for herbal compounds, new medicines and existing products. Here's a wire service story. The Chinese medical regulatory agency had no additional details.
Tobacco-settlement funds will be used to help the medical school at the University of Oklahoma to recruit research scientists and fund a Phase I clinical trial program. An endowed center for cancer research in Oklahoma has about a dozen ongoing projects, the university says. Here's an article.
The FDA approved an anesthetic from Insys Therapeutics that is delivered to cancer patients via the tongue. Pittsburgh electronic patient diary firm invivodata helped to support Insys' pivotal Phase III project. “We had a very good experience working with invivodata and are thrilled with the results they delivered,” said Neha Parikh, senior director of clinical operations at the Arizona-based sponsor. “We feel strongly that without invivodata’s expertise in designing and implementing effective clinical outcomes assessment (COA) data capture solutions, we could not have captured the critical, time-sensitive data we needed to demonstrate the full therapeutic benefit.” Here's a release.
Aptiv Solutions, a contract research organization (CRO), announced a novel technology platform. Aptiv claims the first integrated system to support adaptive trials, combining standard systems for electronic data capture, randomization and drug supplies. Said Michael McKelvey, formerly of ERT, who is Aptiv's executive VP and COO: "AptivAdvantage is a key component of our differentiation as the only service provider to offer both world class design and world class execution of adaptive clinical trials." Here's a release.