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

Cardiovascular Solutions

Download BROCHURE

Centralized ECG Services

Download DATA SHEET

Global Median Beat (GMB)

Download OVERVIEW SHEET

Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Integration of #eTMF and #CTMS eliminates redundancies, improves workflows & enables greater study control. Join th… https://t.co/dnqwBLTvy3
Bioclinica (3 days ago)
Save time and minimize risk with Bioclinica’s Clinical Trial Management System (CTMS) Starter Package. A full-featu… https://t.co/MW4e031hXf
Bioclinica (4 days ago)
Bioclinica’s Resale #IRT offers flexible configuration, delivery in weeks not months, & an affordable, predictable… https://t.co/vVjH0VLpSv
Bioclinica (2 weeks ago)
The Clinical Trial Management System (CTMS) Starter Package from Bioclinica saves time and minimizes the risk often… https://t.co/VRGMjKlzL4
Bioclinica (2 weeks ago)
We are pleased to announce @directbiologics will leverage Bioclinica's IRT solution for its EXIT #COVID19 study. Th… https://t.co/Iun6UrL6Bt
Bioclinica (3 weeks ago)
The integration of Bioclinica CTMS & eTMF with SharePoint enable teams to work in familiar programs & remote work a… https://t.co/QRBt1sdljh
Bioclinica (3 weeks ago)