The point at which a drug moves from preclinical testing to Phase I clinical research marks a strategic milestone for a pharmaceutical or biotechnology company. The primary aim of early phase studies is to obtain insight into a drug candidate’s safety and tolerability profile, and pharmacokinetics.
However, obtaining proof of pharmacodynamic activity and efficacy, or “proof-of-concept” (POC), as early as possible is equally important in defining the compounds ability to make it to the market.
Adding more complexity into early phase study designs provides a solution to obtain pivotal data early.
As a leading Phase I-II contract research organization (CRO), we have an international quality reputation for the complex study designs of clinical pharmacology trials that give you the opportunity to speed up the ‘go / no go decision’ process, while meeting regulatory standards.
As one of the leading European companies in exploratory and clinical pharmacology trials in healthy volunteers, special populations and patients, we have a Clinical Pharmacology unit, and two Phase I Patient units (in Belgium and Hungary).
Our highly skilled and trained experts work with you to determine your early phase clinical strategy, designing trials that are based on your particular circumstances and the demands of international and local regulations. Through them, you will have access to the most recent study designs, pharmacodynamics models, biomarker targets and data management techniques that work together to form a cohesive clinical trial program, including:
- First-In-Human (FIH) trials
- Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Food, gender and age effect studies
- Combined protocols and adaptive designs
- Regulatory Phase I trials
- Drug interaction studies
- BA/BE studies
- Pivotal TQT prolongation trials
- Exploratory Early Phase trials
- Early POC studies
- Biomarker exploration
- Viral Inoculation/Challenge Studies
With over 35 years’ experience in Phase I trial design and execution, we are particularly well placed to meet your clinical trial needs. Our services will help you to meet the standards of the US FDA, EMA, GCP, ICH, ISO guidelines and directives and local regulatory bodies successfully.
We are a trusted and experienced partner, ready to guide you through early phase trials quickly and safely.
To discuss your next early phase clinical research project, contact us today.