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The Power of AI to Enhance Clinical Trials Clinical trials are essential to the development and implementation of safer and more effective devices and medications, but clinical trial success rates have been shockingly low. The likelihood of a new drug advancing to the next trial stage or regulatory approval is less than 14% across …
HiRO Enters U.S. with Acquisition of CRO Courante Oncology Harvest Integrated Research Organization (HiRO), a global contract research organization (CRO), has acquired Courante Oncology, a U.S.-based full-service clinical research provider specializing in oncology product development. HiRO is a boutique CRO serving the Asia-Pacific region. Its acquisition of Courante Oncology extends the organization’s presence into the …
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FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging …
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FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging …
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Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding …
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FDA Announces Additional Steps to Modernize Clinical Trials On June 6, the FDA released E6(R3) Guideline for Good Clinical Practice, a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates …
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FDA Issues Draft Guidance on Use of Decentralized Clinical Trials The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. “Decentralized Clinical Trials for …
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Best Practices and Pitfalls When Going from Concept to Commercialization MedTech Internet of things (IoT) start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position …
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Realizing the Promise of Real-World Evidence in MedTech Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase innovation and accelerate product development, medical technology innovators have been eager to comply. The burgeoning use …
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