Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
Due to an exponential growth in the investment in female health and wellbeing, Forbes and Dealroom reported that 2023 saw 1.14 billion USD raised collectively across 120 deals in ‘FemTech’. ...more
The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials. Originally...more
Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more
Version 1.1 of the European Medicines Agency's (EMA) “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials...more
The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more
The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more
Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a research compliance work plan? - How to better shift your program’s research focus in...more
Report on Research Compliance 17, no. 11 (November 2020) - In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more
We currently live in a world where the rapid spread of COVID-19 has provoked the urge to initiate the search for an effective vaccine or medicines to fight against it....more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more
Anonymisation has always been (and still is) a real challenge for those carrying out clinical research. To shed some light on this matter, the Medical Research Council (MCR) – which is part of UK Research and Innovation – has...more
The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data...more
The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU....more
Blockchain and artificial intelligence (AI) are opening new doors towards improving data efficiency in the life sciences industry. But these technologies may also impose unique limitations and curtail the traditional role of...more
The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more