


Recent Announcement Reveals Supply Chain Risk to Clinical Trials & Patients
Accreditation isn’t expensive, the cost of ICH-GCP violations is! Could the Pfizer / Valneva issue happen to your trial? In 2021 the FDA reported: 36% of all clinical trials fail 51% of clinical trials fail to follow the investigational plan Considering these...
Spotlight on Leadership: Sholeh Ehdaivand, Founder, President & CEO at LMK Clinical Research
Sholeh Ehdaivand has worked in clinical research for over 20 years and has a true passion for making a difference in people’s lives by aiding the development of newer, better healthcare solutions. Having launched LMK eight years ago, the business has continued to grow...
GCP violations lead to Global Leading Pharma Company’s Phase III Trial Discontinuation
Pfizer and Valneva have recently announced the discontinuation of a significant percentage of participants in the U.S. who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR). The rationale for the discontinuation of this Phase III...
Why do Clinical Trial Site Inspections Fail? Reducing Risk and Assuring Quality in Clinical Research
Clinical research is the fastest growing industry in the world worth US$ 49.8 billion in 2022 which is estimated to reach a staggering US$ 84.43 billion by 2030 (ref. Global Newswire). And yet over the past five years the FDA has reported a failure rate of 36% in...