Research: Phase I-IIb
CEDRA provides the experience, personalized research services and flexibility that keeps clients coming back. Tight timelines, difficult enrollment qualifications and unusual study guidelines are challenges our staff welcomes.
CEDRA's staff has enrolled thousands of participants for both inpatient and outpatient trials. Our staff works closely with you to customize data entry and other processes to meet your specific needs. Our 25,000 SF facility in Austin and our 66,000 SF center in San Antonio contain extensive security measures to ensure that study drug supplies, patient information, study samples and associated documentation remain confidential and secure.
Our ability to accommodate large or even multiple cohort trials, combined with our dedicated, experienced staff, enables effective, integrated planning and implementation for Phase I-IIb clinical trials.
Phase I-IIb Study Capabilities
Pharmacokinetics / pharmacodynamics
Pharmacodynamics is often summarized as the study of what a drug does to the body, whereas pharmacokinetics is the study of what the body does to a drug. CEDRA uses PK/PD studies both in vitro and in vivo as an essential part of a rational early compound screening strategy.
Bioavailability
Bioavailability must be considered when calculating dosages for non-intravenous routes of administration. As one of the essential tools in pharmacokinetics, CEDRA scientists give it the attention it deserves.
Bioequivalence
CEDRA’s experience with generic drug development programs, as well as our expertise in study design and regulatory knowledge, insures smooth, efficient bioequivalence studies.
Dose ranging/multiple dose tolerance
Finding the appropriate safe therapeutic dose and dose regimen is an important consideration in early phase studies. CEDRA’s meticulous attention to detail insures accurate results.
Drug-drug interactions
CEDRA utilizes standard CYP450 probe substrates in studies to assess drug metabolism and evaluate drug interactions early in the drug development program.
ADME studies
CEDRA uses radioisotopic labeling to precisely track the passage of a substance through a human system. By including radionuclides in its chemical composition, isotopes of different masses can be separated using mass accelerator spectrometry in microdose or microtrace ADME studies or the compound of interest can be detected using scintillation counting for typical ADE study designs.
First-in-man
Trials where a pharmaceutical test article, previously developed and assessed through in vitro or in vivo studies, is studied in human subjects for the first time presents a risk to volunteers. That’s why you want CEDRA's experience, facilities and advanced capabilities working for you.