Jul 19, 2016, 10:06 by Michael Croft

MUNICH, GERMANY - Jul 19, 2016 - Definiens, the pioneer in Tissue Phenomics solutions for diagnostics development and commercialization and Indivumed, GmbH, based in Hamburg, Germany announced today a strategic partnership to offer a unique combination of tissue-based biomarker validation and assay development with Definiens Cognition Network Technology® for image analysis and data mining

Jul 18, 2016, 11:00 by Michael Croft

Clinical Informatics News | The National Institutes of Health (NIH) has issued a new policy stating that all NIH-sponsored multi-site research protocols within U.S. jurisdiction must use a single Institutional Review Board  across all sites.

Jul 14, 2016, 11:05 by Michael Croft

Clinical Informatics News | The American Medical Association (AMA), in partnership with Scripps Translational Science Institute (Scripps) and The Jackson Laboratory (JAX), have announced a new online program aimed at educating physicians and other health care professionals on the benefits and limitations of genetic testing and when it is appropriate to incorporate it into their practices.

Jul 13, 2016, 08:17 by Michael Croft

Forbes |  Juno Therapeutics has been given the green light to re-start a cancer clinical trial less than a week after regulators put it on hold because of three patient deaths. The Seattle biotech company, a leader in the emerging field of engineered T-cell immunotherapy for cancer, said today the FDA has allowed it to start enrolling patients once again.

Jul 13, 2016, 08:14 by Michael Croft

RAPS |  A team of researchers say that no currently available patient-reported outcomes for heart failure meet the FDA's criteria for supporting product approval.

Jul 12, 2016, 15:20 by Michael Croft

Clinical Informatics News | News and product updates from around the clinical trials industry include a cannabis trial, new options for trial payments, Medidata's Clinical Cloud in Asia, and more.

Jul 8, 2016, 09:25 by Michael Croft

Clinical Informatics News | Contributed Commentary | When developing a new treatment for a rare disease, the first thing developers should do is build a patient registry for their target patient population. Rare disease patient registries are online platforms where patients and caregivers record information about their diagnosis, condition, and treatment experience. These platforms give developers a mechanism to gather valuable insights that will shape their research and help them demonstrate effectiveness to regulators and payers as part of the approval process.

Jul 7, 2016, 11:05 by Michael Croft

Forbes |  After a few weeks of hype around the Obama administration's efforts to speed cancer research, officials tonight announced plans to kickstart efforts around the president's Precision Medicine Initiative.

Jul 6, 2016, 13:02 by Michael Croft

STAT |  The rise of commercial institutional review boards has led to questions over whether they can adequately protect the safety of study participants.

Jul 6, 2016, 09:40 by Michael Croft

PITTSBURGH, PA - Jul 6, 2016 - SAVE JON, a non-profit research accelerator that applies engineering approaches to medicine, today announced that it is relaunching as Curable

Jun 29, 2016, 05:35 by Michael Croft

Clinical Informatics News Roundup | News and announcements are coming fast out of the Drug Industry Association meeting in Philadelphia. Highlights here come from DrugDev, Veeva, inVentiv, Bracket, and MasterControl. The roundup will be updated throughout the week.

Jun 28, 2016, 12:03 by Michael Croft

PHILADELPHIA, PA, UNITED STATES - Jun 28, 2016 - Today, at the Drug Information Association’s (DIA) Annual Meeting, Veeva Systems (NYSE:VEEV) reported the latest findings of the industry’s largest, annual global survey of trial master file (TMF) owners, the Veeva 2016 Paperless TMF Survey

Jun 28, 2016, 06:35 by Michael Croft

Clinical Informatics News | Guest Commentary | Conducting clinical trials is a high stakes game, but disturbingly, the risk of selecting non-performing or underperforming investigative sites is greater than losing at the gambling table. When shooting craps, for example, odds are 17% that the player will role a 7 to start the action, and the odds of actually winning may be even lower. But, the odds of selecting sites that perform well in clinical trials are worse, far worse.

Jun 27, 2016, 15:58 by Michael Croft

DOYLESTOWN, PA - Jun 27, 2016 - Bioclinica®, a specialty clinical trials technology and services provider, today announced Parallel 6 has become the newest member of its eHealth App xChange™, an alliance channel within the eHealth Solutions business segment to advance technology innovation across life sciences and healthcare

Jun 27, 2016, 15:43 by Michael Croft

Healthcare IT News |  Several experts contend that the Office of the National Coordinator for Health IT is attacking the wrong problems and the last thing anyone needs is more prescriptive regulation about EHR functionality, usability and quality measurement.

Jun 27, 2016, 11:42 by Michael Croft

STAT |  Eric Lander says it will take several decades to find a cure for cancer. Speaking at the Aspen Ideas Festival, Lander said patient data sharing would make the difference.

Jun 24, 2016, 15:38 by Michael Croft

Healthcare IT News |  InterSystems' Russell Leftwich, MD, says 'there's still a lot of data yet to be incorporated' with the HL7 standard.

Jun 23, 2016, 14:35 by Michael Croft

DOYLESTOWN, PA, USA - Jun 22, 2016 - Bioclinica®, a specialty clinical trials technology and services provider, today announced the expansion of its extensive Safety & Regulatory Solutions portfolio by introducing three new software products to manage every stage in the pharmacovigilance process

Jun 23, 2016, 09:26 by Michael Croft

Forbes |  Alzheimer's might be the most frustrating graveyard in pharmaceutical R&D. Billions are being wagered on the idea that reducing amyloid plaque buildups will help slow or stop the memory loss and cognitive decline in old age. Nothing really works. Now a startup in South San Francisco has raised $44 million to take a different tack.

Jun 23, 2016, 08:21 by Michael Croft

PRINCETON, NJ - Jun 23, 2016 - Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced the availability of D360 Express