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  1. Jun 19, 2024 · Biomarker assays: Bioanalytical meets CLIA. 19 June 2024. Biomarkers are critical to drug development. Disease-related biomarkers can indicate the potential risk of developing a disease, such as using cholesterol as a biomarker for heart disease. Whereas, diagnostic biomarkers can inform whether a patient has a particular disease, such as using ...

  2. Jun 9, 2024 · Requirements & strategy considerations within clinical trial transparency. The clinical trial disclosure (CTD) landscape has changed significantly over the past decade, with more expansion likely in the coming years. Numerous national regulations and policies require clinical trials to register protocol information and post clinical trial ...

  3. 3 days ago · It can be challenging to keep up to date with new regulations governing the technology and data in decentralised clinical trials (DCTs). While there are no globally applied DCT-specific regulations and the technology tools required to conduct them need to be customised for each trial, there are a series of regulatory guidance documents that have been issued by the European Medicines Agency ...

  4. 5 days ago · As events unfolded, it became important to look at alternative solutions in many areas to minimise the impact of the pandemic and keep trials on track. The need for a more agile approach to clinical monitoring and associated data review has emerged and this demand is likely to continue into the future. Our whitepaper examines best practice in ...

  5. 3 days ago · FLEX ADVANTAGE is ICON's IRT platform for managing patient randomisation, investigator sites and clinical supplies management regardless of complexity or trial phase. The platform is built to meet the needs of each unique study. Flex Advantage is a configurable and fully customisable web-based platform that is fully validated and 21 CFR compliant.

  6. 5 days ago · ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

  7. 3 days ago · CI. Transcript : ICON Public Limited Company, Q1 2024 Earnings Call, Apr 25, 2024. Apr. 25. ICON Q1 Adjusted EPS, Revenue Rise, 2024 Guidance Range Narrowed. Apr. 24. MT. Earnings Flash (ICLR) ICON Reports Q1 EPS $3.47, vs. Street Est of $3.41.

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