Please Wait...

Thorough QT/QTc Studies

Bioclinica offers full TQT study support, including concept and protocol design, ECG management and analysis and regulatory reporting. Bioclinica has supported innovative and conventional TQT trial designs in collaboration with members of sponsor and regulatory team members. We offer proven global capabilities and experience, having successfully completed the first ever regulatory mandated TQT study for a Japanese new drug application (NDA) and the first TQT study in China.

Bioclinica's Full TQT Services include:

  • Study design with full protocol and SAP development
  • Advanced ECG data capture, analysis methodologies and equipment
  • Analysis by US board-certified cardiologists
  • Expertise and guidance for regulatory submission (FDA, EMA, PMDA, and CFDA)
  • Quality assurance including customized reader variability reports
  • Interim cohort reporting
  • Support capabilities for data safety monitoring boards
  • Expert QT report writing
  • WebHeart platform for cardiac safety data management
  • Site training and continuous project support
  • Support in identifying clinical pharmacology research units

From a therapeutic and regulatory perspective, Bioclinica appreciates that not all compounds can complete a formal TQT. Our medical and scientific teams have the experience and regulatory awareness of how best to approach addressing the QT cardiac safety considerations where conventional TQT studies are not possible.

In today's heightened regulatory and R&D environment, it is imperative to partner with a core lab that can deliver quality and consistent ECG data and has capabilities and experience in the successful design, conduct and submission of TQT and intensive QT data.

ADDITIONAL RESOURCES

Thorough QT Studies

Download DATA SHEET

Cardiovascular Solutions

Download BROCHURE

Centralized ECG Services

Download DATA SHEET

Global Median Beat (GMB)

Download OVERVIEW SHEET

Leader in Clinical Trial
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.

Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech… https://t.co/zFiQswIQFb
bioclinica (10 hours ago)
RT @Xtalks: #Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes @bioclinica https://t.co/5osqBkDFKm
bioclinica (10 hours ago)
Want stellar imaging acquisition & assessment in your #clinicaltrial ? Get tips in @bioclinica 's Tim Crowe's blog https://t.co/hzbV3Cmlyc
bioclinica (Yesterday)
Will you be at CBI's IRT conference in Philly Oct 26-27? https://t.co/C7vuxwnCH7
bioclinica (Yesterday)
Must-see live webinar packed w info for those who want to learn about CV safety from the leading experts.… https://t.co/4y5OaUNeIk
bioclinica (5 days ago)
Right at home near our Princeton offc is where to catch us talking all things #RTSM Oct.18-19.… https://t.co/h1OSFwiSFi
bioclinica (5 days ago)

Latest Blogs: