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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.

IAOCR has been committed to transforming the world of clinical research for over a decade. Driving this through the adoption of global best-practice standards for the enhancement and advancement of people and processes in the clinical research industry.

Suki Balendra’s career has spanned academia, industry, central government and currently the UK’s NHS; working with the pharmaceutical Industry. She is working at Imperial College Healthcare NHS Trust as part of National Institute for Health Research (NIHR) Clinical Research Network (CRN), Suki’s role is focused on growing the commercial research opportunities for North West London.

Quality is the backbone of the clinical research industry, and IAOCR is dedicated to upholding and adhering to the highest quality standards. Whilst doing so, IAOCR holds an integral independence from the industry to insure a suitable degree of impartiality, however in spite of this it remains important to be in constant dialogue and listen to the industry.

The growth and widespread use of electronic data capture was one of the factors behind the release of European Medicine Agency’s Reflection Paper on Risk Based Quality Management in Clinical Trials in 2013. Included in the glossary of this document is the definition of Central Monitoring.

IAOCR is delighted to announced that LMK Clinical Research Consulting (LMK) has been awarded IAOCR Certified Academy Partners status for their pioneering of Trial Master File University (TMF University). TMF is the foundation of every clinical trial and holds critical importance to the outcome of clinical trials, yet previously there were no international standards for individuals to work by.