Strategic and quantitative support for your thorough QT waiver
Accelerate your drug development program with a thorough QT (TQT) study waiver informed by concentration-QT (c-QT) modeling. Our integrated team of clinical pharmacology and pharmacometrics consultants will work with your team to outline a waiver strategy, execute the c-QTc modeling, and integrate information for regulatory submission.
What's included
- c-QTc analysis and modeling
- Strategy and guidance
- Submission-ready documentation
Clinical trial design
Integrate quantitative insights with our expertise to de-risk clinical trial design
Clinical pharmacologyPharmacometrics
Exposure-response modeling of efficacy and safety
Quantitative models to describe and predict your drug’s efficacy and safety
Pharmacometrics
Mechanistic modeling (PBPK and QSP)
Bottom-up modeling integrating biological knowledge and in vitro data
Pharmacometrics
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