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The Informed Patient: How Biosample Management Is Evolving For Consent
Clinical Research News | Rather than get too caught in the weeds of sample management, Merk KGaA’s head of clinical trial biosample management focuses on the informed patient: making sure that the patient is fully consented and aware of what samples are going to be collected and what are they going to be used for—even when that calls for peering a bit into the future.
Feb 5, 2019
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How Real World Data Changes Clinical Trials, And What That Means For Patients
Clinical Research News | It’s an exciting time for real-world data and evidence. With more data available than ever—and an FDA commissioner who views the use of real-world data to improve regulatory decisions as a key strategic priority for the FDA—our options for including new data sources cover the spectrum of drug discovery and clinical trials.
Feb 1, 2019
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Real Risk, Real Quality: Risk-Based Monitoring In Clinical Trials Today
Clinical Research News | Companies need to shift their perspectives so they are measuring real quality parameters, data quality issues, and safety issues, according to Andy Lawton.
Jan 31, 2019
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TrialAssure Creates Higher Education Discount Pricing Model For Clinical Trial Disclosure Reporting Software
Clinical Research News Brief | TrialAssure announced a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing all clinical trial results in a cost-efficient manner.
Jan 30, 2019
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Align Clinical CRO, ZappRx, SAP, And More: News From January 2019
Clinical Research News | January was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Align Clinical CRO, ZappRx, SAP, and more.
Jan 30, 2019
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A Realist Looks At AI In Clinical Trials
Clinical Research News | When assessing new technologies for clinical trials, one needs to be both visionary and skeptical. That seems to be even more true for AI technologies.
Jan 28, 2019
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FDA Announces New Guidances Focusing On Risk Evaluation And Mitigation Strategy
Clinical Research News | The FDA's commissioner, Scott Gottlieb, released a statement today announcing the availability of two guidances that will help improve the agency’s ability to ensure that the risk mitigation programs put in place for certain drugs and biologics as a requirement of their approval are working.
Jan 24, 2019
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Aetna, Anthem, HCSC, PNC Bank, IBM To Establish Blockchain-Based Ecosystem For Healthcare Industry
Clinical Research News Brief | Aetna, Anthem, Health Care Services Corporation (HCSC), PNC Bank, and IBM today announced a new collaboration to design and create a network using blockchain technology to improve transparency and interoperability in the healthcare industry.
Jan 24, 2019
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Modernizing Clinical Trials For Patients With Cancer
JAMA Network | In this Viewpoint, directors at the National Cancer Institute (NCI) review reforms to the NCI clinical trials program, including use of historical controls and a push to reduce the financial pressures of clinical trials.
Jan 24, 2019
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Temperature-Stable Experimental Tuberculosis Vaccine Enters Clinical Testing
National Institutes of Health (NIH) | Vaccinations have begun in a Phase 1 human clinical trial testing a freeze-dried, temperature-stable formulation of an experimental tuberculosis (TB) vaccine candidate.
Jan 23, 2019
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What Is Holding Back The Adoption Of eConsent?
Clinical Research News | The eConsent field is challenging: on the one hand it represents a major improvement in the consenting process for clinical trial participants. On the other hand, it is fraught with regulatory uncertainties and industry ambiguity. Tearing apart this tangle will be necessary for eConsent to do what the technology is meant to do: inform trial participants and speed enrollment.
Jan 23, 2019
