Spotlight on Leadership – Dr Roberto Aguirre, VP, Global Research Director, AGA Clinical Trials
Dr Roberto Aguirre is VP, Global Research Director at AGA Clinical Trials, a leading clinical trial site that strives on excellence and collaboration. Roberto’s career led unexpectedly into Clinical Research when he moved to the USA and he has excelled in the field...
Spotlight on Leadership – Danielle Mitchell, CEO and Founder of Black Women in Clinical Research
Danielle Mitchell, CEO and Founder of Black Women in Clinical Research (BWICR), took her own route into clinical research; and has continued to take her own route having established a career in the field. Shocked by the lack of diversity within the Industry, Danielle...
How to Conduct a Mid-Year Self-Review
Guest Post from Sylvia Wambui – Black Women in Clinical Research A mid-year review is a chance to step back and take notes of the hits, misses, and learning from the past 6 months and plan how many milestones you need to take in front of you. A review will not only...
The Evolution and Continued Success of TMF University
LMK recognized a void in the area of educational excellence and regulatory knowledge surrounding the management of the TMF in the clinical trial space. While there are many webinars and conferences related to TMF, most provide only foundational knowledge and do not...
Competence and Clinical Research
A word that is finding increasing use in the clinical research sector is competence. But what does it mean and what is its significance? Competence can be defined as the ability of an individual to demonstrate knowledge, skills and behaviours. When someone is...
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...
Lifting the Veil on Clinical Research Certification
Navigating the Confusing World of Accreditation and Certification Clinical research certification, certified clinical researcher, certified project manager, qualified clinical researcher, certificates, accreditations, qualifications, etc, etc, etc. With so many...Get Accredited
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