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Impact of the In-Vitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing – 2024 Report – ResearchAndMarkets.com

March 5, 2024 Off By BusinessWire

DUBLIN–(BUSINESS WIRE)–The “Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing – 2024” report has been added to ResearchAndMarkets.com’s offering.


This landmark report includes 90 biopharmaceutical participants from the United States and Europe and explores the impact of these delays on clinical trial CRO partnerships, with detailed findings on potential strategies and/or shifts to be implemented by biopharmaceutical companies to mitigate the current and expected delays caused by the IVDR.

In Vitro Diagnostic (IVD) tests are critical to clinical trial operations, serving to help select patients in clinical trials, provide accurate efficacy results, monitor patient response, and more. In May of 2022, the In Vitro Diagnostics Regulation (IVDR) in the European Union and the European Economic Area (EU/EEA) went into effect, seeking to ensure higher patient safety for medical devices, requiring device manufacturers to conduct more stringent safety and performance studies for said devices.

As a result, current and pending drug clinical trials utilizing IVD tests now must also adhere to the IVDR. Compliance among clinical drug trials with the IVDR means IVDs used in clinical trials providing a diagnostic test result that will influence patient medical management must go through a Performance Study, which requires submission of a Performance Study Application (PSA). However, this process is currently complex and uncoordinated, resulting in delays in clinical trials and patients waiting longer to participate in clinical trials, or even not participating at all.

In the report, the analysts provide commentary and interpretation of the data, which reflects more than 30 years of experience consulting to many of the leading global biopharmaceutical companies, clinical development CROs and CRO industry analysts. The report looks at the preferences among biopharmaceutical respondents for CRO partnerships and clinical trial site locations and how might these preferences change for clinical trials ongoing in the EU/EEA that are/will be impacted by the IVDR.

Key Topics Covered:

I. Study Background

II. Executive Summary

III. Methodology

IV. Detailed Findings

V. Respondent Demographics

List of Figures

  • Percentage of Clinical Trials Involving IVDs
  • Percentage of Clinical Trials Involving IVDs with Sites in EU/EEA Countries
  • Familiarity with IVD Regulation
  • Delays in EU/EEA Countries Due to IVDR and PSA
  • Likelihood to Take Select Actions Given Delays – Current Clinical Trials
  • Likelihood to Take Select Actions Given Delays – Future Clinical Trials
  • Impact of Continued Delays on Clinical Trials Involving IVDs with EU/EEA Sites
  • Preferences for Trials Shifted from EU/EEA Countries – Europe
  • Potential CRO Strategies for Trials Shifted to UK and Non-EU/EEA Countries
  • Preferences for Trials Shifted from EU/EEA Countries – APAC
  • Preferences for Trials Shifted from EU/EEA Countries – LATAM
  • EU/EEA Regulatory Landscape Market Leaders
  • Respondent Demographics

Companies Mentioned

  • IQVIA
  • PPD/ Thermo Fisher Scientific
  • Parexel
  • Charles River Labs
  • ICON/PRA
  • Fortrea/ Labcorp/ Covance
  • Syneos Health
  • Medpace
  • Worldwide Clinical Trials
  • Precision for Medicine
  • UBC
  • PSI
  • Allucent/ Pharm-Olam
  • Emmes
  • Celerion
  • Premier Research
  • CTI Clinical
  • Ergomed/ MedSource
  • Clinipace/ Caidya
  • TFS HealthScience

For more information about this report visit https://www.researchandmarkets.com/r/2sr2yf

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