Jan 30, 2019 6:30:00 AM
QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD, statistical modeling and the modeling of go-no-go decision rules. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those...
Topics: Clinical Research Services, Statistical Analysis, careers, clinical data management, clinical research, Data Management, Statistical Programming, quantitative decision-making, model-informed-drug-development, Early Phase Trials, Phase I, pharmacometrics, pharmacology
Jan 10, 2019 8:00:00 AM
Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We recently spoke with Nand for the Cytel podcast to gain his thoughts on the unique aspects of Phase 1 development and where innovative approaches supported by thorough planning can meet these challenges head-on. Read on for key insights or listen to the podcast.
Topics: clinical research, clinical trials, biostatistics, Cytel Strategic Consulting, clinical development, Phase I, pharmacometrics, quantitative decision-making
Nov 12, 2018 8:04:00 AM
In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a...
Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, biostatistics, Statistical Innovations in Clinical Development, randomization, patientricity
Oct 18, 2018 11:09:00 AM
In this blog, we talk with Simon Kirby, former Senior Director at Pfizer, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. Simon will address the topic of Selection Bias for Treatments with Positive Phase 2 Results and in this blog he explains why this is a key topic of particular relevance for pharmaceutical companies...
Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, go-no-go, biostatistics, Statistical Innovations in Clinical Development, randomization
Oct 5, 2018 7:00:00 AM
We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In this blog, we sit down for a discussion with Stephen about his career in statistics, his advice for early career statisticians, his upcoming research, and the topic of his presentation at the East User Group Meeting “70 Years Old and Still Here: the Randomized Clinical Trial...
Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, go-no-go, biostatistics, Statistical Innovations in Clinical Development, randomization
Sep 27, 2018 9:00:00 AM
In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. The topic Heiko will address is Decision Making in Development Programs with Targeted Therapies and he explains to us why this is a key topic for pharmaceutical companies today as they...
Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, Biomarkers, go-no-go
Jan 30, 2017 9:50:24 AM
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD) characteristics, and of course identify the maximum tolerated dose (MTD).
Conventionally, SAD and MAD studies were conducted separately, but increasingly are combined...
Topics: biostatistics, adaptive trials, adaptive designs, Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Compass, Dose-Finding, Phase 1, Phase I