Info & Opinion
May 27, 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
India's Wipro, one of the largest IT consulting firms, has built a specialized clinical trial portal for communication and project/document management. "There is an intensifying need in the market for a platform that can centralize information, manage financing, facilitate accurate reporting, automatic scheduling and provide the ease of patient recruitment," the company said in a release, claiming to be able to save 20-30 percent of the time in a clinical trial.
Drug safety experts at Sentrx and translation company Transperfect are aligning their services. The goal is to process and translate spontaneous adverse events reports more rapidly. "The trial interactive portal solution will enable direct safety information collection on a global basis from investigative site personnel via multiple sources, including fax, email, direct-entry, or by telephonic means, into a secure data portal. The approach will speed safety data exchange between safety teams and reporters while enhancing sponsors’ ability to support multiple stakeholders globally," the companies said in a release.
Almac added five new drug supply depots to its Asian network of locations to support industry-sponsored research. With the new locations, the company currently has 36 depots globally.
PPD recruited Edward Ian away from PRA and named him VP for clinical development in Asia. He'll be based in Asia, where PPD has more than 1,000 employees. "Edward Ian brings more than 15 years of clinical operations, central laboratory management, quality management systems and project management expertise through his long tenure with multinational companies in Asia Pacific and the United States," said Paul Colvin, PPD's executive VP of global clinical development.
Academic spine surgeons writing in The Spine Journal harshly criticized the scientific integrity of both Medtronic and numerous academic physicians who the Minnesota firm employed in clinical trials of a bone growth agent called Infuse. In a review of data published in 13 articles, the authors concluded that Medtronic's investigators omitted any mention of key safety risks. “It harms patients to have unaccountable special interests permeate medical research,” the authors wrote. Under pressure from Congress, the company had previously disclosed paying some of the physicians studying Infuse in excess of $10 million each. So far, Medtronic has issued a statement but is not directly disputing the allegations. Instead, it is insisting that different data, submitted to the FDA, were complete and correct. For the public, the saga raises additional questions about the statistics in industry-sponsored research and whether the most thorough assessment of new drugs and devices is occurring in the offices of regulatory agencies—or at medical journals.