This series of blog posts describes some of the benefits of partnering with Nuventra to meet your PK/PD needs in drug development. This post focuses on CRU selection and evaluation.
Phase 1 Clinical Study Clinical Research Unit (CRU) Selection and Evaluation:
- As consultants in clinical pharmacology and pharmacokinetics, Nuventra has helped conduct many Phase 1 healthy volunteer studies in addition to many other types of clinical pharmacology investigations (drug-drug interaction, ADME [mass balance study], hepatic impairment study, renal impairment study, elderly PK study, food effect PK study, PK/PD analysis, etc.).
- Nuventra’s consultants have visited most of the commercial Phase 1 CRU s in the United States and have a unique insight into selection of the right CRU for each type of clinical pharmacology study.
- A client came to Nuventra with a Phase 1 First-time-in-human (FTIH) study that required healthy volunteers to produce a bone marrow sample. Within 3 business days, Nuventra assessed multiple Phase 1 CRU s for this capability and provided the client with valuable information to progress their program forward rapidly.
Take home message
Nuventra can act as an extension of your R&D team to provide the type of ‘in-house’ clinical pharmacology, PK/PD, and popPK expertise that companies usually don’t have on staff. We have the experience to rapidly and efficiently assist clients with planning, conducting, and analyzing a Phase 1, healthy volunteer, clinical pharmacology study at phase 1 units (CRUs).