Electronics Patients Safety Training 
MedCity News
FEBRUARY 6, 2024
The manual data population of site folders and electronic trial master files (eTMFs), for example, is time-consuming and poses issues, including limited document security and data privacy, archiving and retrieval difficulties and human error, resulting in up to a 25% failure rate.
Nixon Gwilt Law
APRIL 22, 2024
If a Covered Entity or Business Associate is using PHI in model development (training data for example), deployment, or maintenance of a healthcare AI system, then HIPAA obligations likely apply. Effective: Ensures that DSIs achieve their intended outcomes, improving clinical decision-making and patient care. When does it apply?
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European Pharmaceutical Review
MARCH 12, 2024
If data used to support the safety , efficacy and quality of pharmaceutical products is compromised or unreliable, it can lead to regulatory non-compliance, product recalls, and most importantly, harm to patients who depend on those medications. Training and education. Good documentation practices. What is an effective solution?
European Pharmaceutical Review
DECEMBER 14, 2023
Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. As of October 2023, 62.93
European Pharmaceutical Review
JULY 20, 2022
Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.
pharmaphorum
DECEMBER 22, 2022
The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness.
pharmaphorum
OCTOBER 18, 2022
Now that the COVID-19 pandemic has provided the industry with a solid foundation of experience with decentralised trials, it is appropriate to reflect and ask whether DCT studies are truly helping to address long-standing issues in research and development for sponsors, study teams and, most importantly, patients.
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