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FDA Guidance and Clinical Trials

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The Food and Drug Administration (FDA) released Clinical Trial Imaging Endpoint Process Standards guidance for clinical trials industry. Why? To standardize. To automate. To move closer to zero-delay clinical trials. Read AG Mednet's perspective on this FDA guidance.

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FDA Guidance and Clinical Trials

  1. 1. WHEN FDA GUIDANCE AND TECHNOLOGY INNOVATION MEET
  2. 2. the Food and Drug Administration released Clinical Trial Imaging Endpoint Process Standards guidance for clinical trials industry. In March 2015,
  3. 3. TO STANDARDIZE. TO AUTOMATE. TO MOVE CLOSER TO ZERO-DELAY CLINICAL TRIALS. WHY? AND WHY NOW?
  4. 4. TECHNOLOGY Verifies that scans meet protocol criteria. Is the critical tool to make this FDA guidance a reality. Ensures that image data is properly de-identified. Guarantees case report forms are consistent with the images they complement.
  5. 5. Sponsors must optimize the quality of imaging data obtained in clinical trials. With the increased significance of patient scans as surrogate endpoints in clinical trials, the ability to collect imaging data that meets protocol requirements is more important than ever before. AG Mednet technology meets and exceeds this FDA guidance.
  6. 6. Sponsors, core labs and clinical research organizations (CROs) collecting imaging time points as part of their trial protocols rely on AG Mednet’s automated system. How? By enhancing site compliance, reducing site queries and enabling secure electronic transfer of scans from thousands of locations around the world.
  7. 7. Aligning with AG Mednet’s core technology, the FDA guidance focuses on: critical imaging acquisition, display, archiving, and interpretation process standards when imaging is used to assess a trial’s primary endpoint.
  8. 8. additional standards regarding imaging endpoint process standardization for clinical trials. THE GUIDANCE RECOMMENDS
  9. 9. those standards. AG MEDNET MANDATES
  10. 10. AG MEDNET STANDARDS ENSURE THAT: A verifiable record of the imaging process exists. Quality of imaging data is maintained.Imaging data complies with a trial’s protocol.
  11. 11. AG Mednet’s Submission Quality & Compliance with Longitudinal Analysis is the only automated software that checks data across subject visits – at the source – and makes determinations about consistency and validity of imaging data as a clinical trial progresses.
  12. 12. QUALITY   + SPEED AG MEDNET IMPROVES THE OF CLINICAL TRIALS
  13. 13. by   AUTOMATING IMAGE DATA COLLECTION and promoting compliance with trial protocols to ensure images are consistently performed
  14. 14. WITH THE RIGHT EQUIPMENT
  15. 15. TO THE RIGHT SPECIFICATIONS
  16. 16. The FDA and AG Mednet agree that AUTOMATION STANDARDIZATION +
  17. 17. CREATE CONSISTENCY THAT DRIVES ACCURATE CONCLUSIONS.
  18. 18. SAVES SPONSORS TIME AND MONEY.
  19. 19. HELPS CORE LABS EXPAND BANDWIDTH TO TAKE ON MORE TRIALS.
  20. 20. Read more about the FDA’s Clinical Trial Imaging Endpoint Process Standards Guidance for Industry here: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm268555.pdf Learn about AG Mednet’s Longitudinal Analysis technology here: http://www.agmednet.com/clinical-trials-solutions/submission-quality-compliance-module/ Download our white paper to learn how to help the clinical trials industry achieve zero-delay clinical trials. http://info.agmednet.com/white-paper-quality-begins-at-the-source/?__hssc=&__hstc=&hsCtaTracking= 4a2a0c6c-41a6-40f5-b10c-118932481f22|afb85200-8562-4841-a6f5-151b64b87f17

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