Jun 23, 2016, 05:10 by Michael Croft

Clinical Informatics News | As clinical trials become more complex and zero in on narrower patient populations, time spent in site start-up is increasing. To address this growing problem and identify and enroll hard-to-find patients more quickly, Quintiles recently launched its Precision Enrollment program, which is designed to activate site start-up within 21 days of patient identification.

Jun 22, 2016, 18:26 by Michael Croft

RAPS |  On Wednesday, the European Medicines Agency and the US Food and Drug Administration began exchanging more information on the best practices of involving patients in the development, evaluation, and post-authorization tracking of medicines.

Jun 22, 2016, 14:37 by Michael Croft

PHILADELPHIA, PA, UNITED STATES - Jun 23, 2016 - ERT, a leading eClinical solutions provider, including high-quality patient data collection and analysis, today announced a major release of its Insights Cloud trial oversight solution, with features to optimize transparency, flexibility and accountability for clinical trial sponsors and Clinical Research Organization (CROs)

Jun 22, 2016, 10:00 by Michael Croft

Clinical Informatics News Brief | WIRB-Copernicus Group announced its acquisition of CenterWatch today. Kenneth A. Getz, CenterWatch founder and owner, will join the WCG board of directors. The CenterWatch leadership remains the same.

Jun 22, 2016, 09:44 by Michael Croft

PRINCETON, NJ - Jun 22, 2016 - WIRB-Copernicus Group® (WCG™), one of the world's leading providers of solutions that measurably improve the quality and efficiency of clinical research, today announced its acquisition of CenterWatch, the leading provider of clinical trial industry news and information, and the addition of Kenneth A

Jun 21, 2016, 16:44 by Michael Croft

Xconomy |  Despite worries about conflict of interest, a National Institutes of Health committee that oversees the use of gene therapy and other cutting edge biomedical technologies voted today to let researchers move ahead with the CRISPR-Cas9 clinical trial.

Jun 21, 2016, 13:55 by Michael Croft

PHILADELPHIA, PA, UNITED STATES - Jun 22, 2016 - ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, today announced a data license agreement with Dexcom to integrate glucose information captured via continuous glucose monitoring (CGM) and traditional self-monitoring of blood glucose (SMBG) with symptomatic / quality of life data collected via its its electronic Clinical Outcome Assessment (eCOA) system

Jun 20, 2016, 14:16 by Michael Croft

Receives prestigious When Work Works Award for the fourth time   Chapel Hill, NC (June 15, 2016) – Rho, a full service contract research organization (CRO) focused on bringing new products to market

Jun 20, 2016, 13:40 by Michael Croft

Clinical Informatics News  Commonwealth Informatics announced this morning that it has been awarded a contract by the Food and Drug Administration to provide consulting services and technical assistance to the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to support their use of the Empirica Signal software for quantitative safety signal detection and safety signal management.

Jun 20, 2016, 12:28 by Michael Croft

STAT |  The approval marks an early but significant step in the effort to combat a disease that has quickly emerged as a global health threat.

Jun 20, 2016, 09:41 by Michael Croft

MUNICH, GERMANY - Jun 20, 2016 - Definiens, the pioneer in Tissue Phenomics solutions for diagnostics development and commercialization, today announced that chief commercial officer Merrilyn Datta, PhD, will present at Rational Combinations 360°, being held in New York, NY from June 23-24, 2016

Jun 17, 2016, 09:59 by Michael Croft

Xconomy |  Paratek Pharmaceuticals has stuck with its antibiotic omadacycline over the years, even as three of the company's pharmaceutical partners bailed on the drug. Today the company said that omadacycline hit all its main and secondary goals in a late stage trial.

Jun 15, 2016, 17:07 by Michael Croft

DOYLESTOWN, PA - Jun 15, 2016 - Bioclinica®, a specialty clinical trials technology and services provider, today announced the debut of two new divisions, creating an integrated offering focused on patient engagement

Jun 15, 2016, 16:43 by Michael Croft

PHILADELPHIA, PA, UNITED STATES - Jun 16, 2016 - ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, today announced that its’ Innovation Lab will travel to the Drug Information Association (DIA) Annual Meeting to give clinical researchers access to advanced models for clinical trials and patient data collection

Jun 15, 2016, 16:11 by Michael Croft

Popular Science |  An editorial out this week in the British Journal of Sports Medicine says that women have been routinely excluded from clinical trials due to, "complexities of the menstrual cycle."

Jun 15, 2016, 14:25 by Michael Croft

Clinical Informatics News | On Sunday the Food & Drug Administration is launching the first phase of a campaign to encourage minorities to participate in clinical trials. With a series of six videos, blogs, and an infographic, FDA hopes to increase awareness about clinical trials in minority communities and encourage discussion and participation.

Jun 15, 2016, 10:28 by Michael Croft

FDA Law Blog |  On June 10, FDA issued the draft guidance, "Dissemination of Patient-Specific Information from Devices by Device Manufacturers." At a mere six pages long, this guidance is not tipping the scales by any means, but its pages contain some important information for device manufacturers.

Jun 15, 2016, 08:42 by Michael Croft

PRINCETON, NJ - Jun 15, 2016 - WIRB-Copernicus Group® (WCG™), one of the world's leading providers of solutions that measurably improve the quality and efficiency of clinical research, today announced an industry-transforming agreement with karmadata, the market leader in clinical trial database and decision support applications

Jun 15, 2016, 06:01 by Michael Croft

PHILADELPHIA, PA, UNITED STATES - Jun 15, 2016 - ERTIntroduces Centralized DLCO Services for Respiratory TrialsCentralization reduces data variability, improves trial efficiencies ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, today introduced its  Centralized Services  for assessing diffusing capacity of the lungs for carbon monoxide (DLCO) data in respiratory clinical trials

Jun 14, 2016, 09:55 by Michael Croft

STAT |  Drug firms may be seeing improved success in their clinical trials, but whether that trend is sustainable is an open question, an analysis says.