Clinical Trial Podcast
JULY 31, 2022
He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.
Cloudbyz
AUGUST 9, 2023
The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.
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Cloudbyz
FEBRUARY 29, 2024
This leads to improved data accuracy and reliability, laying a robust foundation for comprehensive safety assessments during clinical trials. Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials.
Cloudbyz
MAY 24, 2023
The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Consumer product clinical trials typically involve the evaluation of new formulations or ingredients for safety, efficacy, and user acceptability.
pharmaphorum
OCTOBER 27, 2022
To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials.
FDA Law Blog
JANUARY 1, 2024
The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Patcos Cosmetics Pvt. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. Shah, M.D.,
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