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

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.

Bioclinica Delivers Individual Case Safety Report (ICSR) Processing w Quality & Consistency While Crossing One Mil… https://t.co/77NOME2Dj7
bioclinica (Yesterday)
Who made the BioSpace list of 11 most innovative life sciences companies in the world? Ck it out here via @biospace… https://t.co/f9vtRpsbMW
bioclinica (Yesterday)
BREAKING: With a passion for Drug Safety, we’re delighted to share @bioclinica #pharmacovigilance crossed 1M ICSR c… https://t.co/PAdROjo7tE
bioclinica (2 days ago)
RT @isciencebox: Draft and Final FDA Guidances Detail Development of New Drugs for Neurological Disorders @RAPSorg https://t.co/cAewLypUY7
bioclinica (2 days ago)
RT @RAPSorg: Final @US_FDA Rule Requires Medical Device Trials Outside US to Conform to GCP | #Regulatory Focus https://t.co/jgwaqxfiXl #FD…
bioclinica (2 days ago)
Congrats @bioclinica on @Clin_Info_News Best Practices Award 4 "Transformational Med. Imaging in #ClinicalTrials. '… https://t.co/NxauNywq23
bioclinica (1 week ago)

Latest Blogs:

Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen