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

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

RT @lauren_chazal: OA is highly prevalent worldwide! Let's work together globally to fight OA... #orasi2017 @bioclinica https://t.co/sAofL…
bioclinica (2 days ago)
Awesome #TYCTWD in our Audubon office yesterday! Great grp of kids.Thanks all for making it a big hit & a day to r… https://t.co/gLZilvN4Wy
bioclinica (2 days ago)
[Fun Friday] When It Comes to Success, Age Really Is Just a Number Via NYT https://t.co/u82mvoYxhg
bioclinica (2 days ago)
RT @eClinical_Jen: Ron Fitzmartin of FDA states "The Reason why the FDA supports standards is to get medical products approved faster" 👍#C…
bioclinica (3 days ago)
RT @eClinical_Jen: Donate your health data to research! Check out the S4S project mentioned by @iamnotthelotus at #CDISCEurope #pharma http…
bioclinica (3 days ago)
RT @lauren_chazal: #oarsi2017 what IS the future of OA? @bioclinica https://t.co/Q9MhW8F50g
bioclinica (3 days ago)

Latest Blogs: