Phase I Early Clinical Development
FOCUS ON COMPLEX STUDY DESIGN
At PPD, we understand that early phase development in complex studies requires a highly coordinated effort to anticipate challenges, recruit the right subjects, engage experienced investigators and design a trial that will establish a platform for later-stage clinical success.
PPD’s early development team performs complex studies through our global network of sites. With over three decades of experience conducting Phase 1 trials, our teams bring a unique understanding on how high-quality performance looks and we work with our sites to ensure conduct and data meets an exacting standard.
IN-DEPTH Phase I SCIENTIFIC AND THERAPEUTIC EXPERTISE
FLEXIBLE SOLUTIONS CUSTOMIZED TO FIT YOUR Phase I STUDY NEEDS
PPD provides comprehensive and flexible pharmacokinetic (PK) and pharmacodynamic (PD) support of Phase I-IV clinical trials. We offer clinical pharmacology expertise as part of an integrated drug development program or as a discrete stand-alone service with clinical, scientific and regulatory experience in a variety of areas.
- Translational Medicine including toxicokinetics (TK)
- Clinical pharmacology program and protocol development and support
- Analysis and interpretation of PK and PK/PD data
- Scientific and medical expertise aligned to each client’s pipeline
- Comprehensive access to patients, healthy volunteers and special populations
- Experience in design and execution of both adaptive and traditional early phase studies
- A fit-for-purpose, flexible operating model
Seeking Ways to Ensure Participant Safety in First-in human Trials
Kirsten Messmer, Ph.D., R.A.C., principal regulatory affairs specialist, details changes in regulatory guidelines for first-in-human trials.