Blog

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 equip attendees with the skills and behaviors to operationalize TMF management. This void led to the inception of the TMF University, which has been Independently accredited by IAOCR.

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 competent in a particular job role they have mastered all the knowledge skills and behaviours required for that position or function.

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 and 51% of clinical trials fail to follow the investigational plan.

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 driven by Sholeh’s passion for innovation and improvement.

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 clinical trial has been cited as “violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator”.

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 clinical trial site inspections.

Guest Post from Dr Suki Balendra, Life Sciences Lead, Imperial College Healthcare NHS Trust

Guest Post from Dace Dimza-Jones – Industry Facilitator, NIHR Clinical Research Network Greater Manchester

Quality is the backbone of what IAOCR strives to deliver both directly and by supporting the Clinical Research Industry. As part of our ongoingcommitment to the Industry, we have bolstered our team with the addition of Sarah Everitt who is our new Vice President of Operations.