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Regulatory Expertise

Led by tenured senior executives with extensive clinical research experience, Bioclinica's global cardiac safety and efficacy regulatory expertise is second to none. Bioclinica's unmatched regulatory leadership is well recognized and backed by ongoing professional relationships with key authorities and panels. We have worked with the ICH and FDA to advance industry standards and guidance in the conduct of TQT studies and have successfully completed the first ever regulatory mandated TQT studies in both Japan and China. Bioclinica has supported the design and specific cardiac monitoring technology for our sponsors on studies requested by regulatory authorities. The data from such studies has met the predefined goals established by both sponsor and regulatory organizations.

Bioclinica's regulatory services include:

  • Protocol consultation and guidance throughout development life cycle
  • Fast-tracked ECG and imaging data regulatory submissions and archiving
  • Audit preparation and support
  • FDA ECG warehouse submission
  • Integrated Cardiac Safety Summary reports in support of the alternative approach to formal TQT study requirements

Industry Associations

Bioclinica continues to accelerate drug development, working in tandem with regulatory bodies and key clinical research associations to establish and maintain core lab industry standards for cardiac safety services.

Our contributions include interaction with the following:

  • Metrics Champion Consortium (MCC)
  • Cardiac Safety Research Consortium (CSRC)
  • International CardioOncology Society (ICOS)
  • ICH-E14 expert advisory panel
  • American Society of Hypertension (ASH)
  • American Telemedicine Association (ATA)

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Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Our Medical Imaging team is in the spotlight for a job well done! https://t.co/fkmt0zvPhf https://t.co/D7YMTeiSd3
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RT @melfass: "What this agreement means is that we can allocate scarce resources to areas of higher risk" @US_FDA on MRA with @EMA_News at…
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RT @DrugInfoAssn: What has been the biggest takeway for your organization so far? Tweet @ us using #DIA2017
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"Q" on #RBM & Total Quality Mgmt? @Kristin_Mauri has "A" @DrugInfoAssn #DIA2017 https://t.co/MqCxkmAfa0
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Kristen Mauri shows the @DIA audience the value of risk based monitoring https://t.co/ssJCfc9gQ5
bioclinica (4 days ago)
Innovation Theater Kristin Mauri of @bioclinica presenting on RBM & TQM @DrugInfoAssn #DIA2017 https://t.co/zsGroQcpiU
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