Clinical Pharmacology (Phase I-IIa)
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Phase I
Phase IIa
Clinical Support Services
Phase I
As potential drugs progress to clinical testing, the initial human trials (first-in-human trials) provide a preliminary evaluation of drug safety, tolerance and pharmacokinetics. As the drug candidate progresses through clinical development, additional clinical pharmacology studies, such as drug-drug interaction, food effect and special population studies, will be conducted.
With eleven Clinical Research Units in the United States and United Kingdom, Covance has helped hundreds of drug development companies progress their compounds from preclinical to proof-of-concept studies. Each Clinical Research Unit has a dedicated team of professionals, including physicians, scientists, project managers, nurses and recruiters. With Covance, you also have access to bioanalytical chemistry, radiosample analysis, central laboratories, centralized electrocardiogram (ECG) services and a team of pharmacometrics professionals.
Phase I Study Designs
- First-in-Human
- Dose tolerance escalation
- Bioavailability/bioequivalence
- Dose proportionality
- Absolute bioavailability
- Food effect
- Appetite studies
- Drug/drug interaction
- Radiolabeled AME
- Definitive QTc
- Age/gender
- Controlled release
- Nutritional
- Pharmacodynamics
- Japanese bridging
- PET imaging
- microdose
Phase IIa
Proof-of-Concept studies are classically seen as those that demonstrate clinical relevance of a novel NME intended to treat a disease through establishing efficacy. However, the objective of Phase IIa clinical trials has expanded: Studies are designed to generate go/no go criteria from patient populations by also looking at safety, tolerability, PK/PD profiling and commercial viability.
Our dedicated Phase IIa team is comprised of highly experienced professionals who design, initiate and manage all aspects of the study. Similar to our Phase I capability, each sponsor has access to bioanalytical chemistry, central laboratories, centralized ECG services, regulatory support, and a team of pharmacometrics professionals.
Phase IIa Services
- Feasibility and risk assessment
- Site selection and prequalification
- Project management
- Clinical and medical monitoring
- Site management
- Study design
- Contract and financial management
- Recruitment support
- Staff training
- Protocol and CRF development
Clinical Support Services: Phase I & Phase IIa
- Bioanalytical chemistry
- Central laboratories
- Centralized ECG reading and management
- Radiosample analysis
- cGMP pharmacy
- Pharmacometrics
- Pharmacokinetics
- Pharmacodynamics
- Data management
- Biostatistics and
programming
- Medical writing
- Program management
- Regulatory Consulting
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