Whether you’re testing dose ranges in healthy volunteers or cancer patients, conducting pilot studies to investigate dose-response or dose frequency, or pursuing numerous other safety and efficacy characteristics, our clinical experts can help.
Phases I–IIa are critical for determining next directions as well as satisfying regulators and reassuring stakeholders. Our significant early-phase experience and teamwork culture provide consistency and continuity. Dedicated staff keep their skills current with ongoing training.
Clinical Pharmacology Studies
We are highly experienced in:
- First-in-Human Single Ascending Dose/Multiple Ascending Dose
- Drug-Drug Interaction
- QT Cardiac Safety
- Food Effect
- Human AME Studies
- Serial and Continuous Cerebral-Spinal Fluid (CSF) Collection
- CNS Cognitive Evaluation
- Inhalation/Intranasal Delivery
- Intratympanic Injection
- Drug-Alcohol Interaction
- Female OC-Drug Interaction
Patient and Special Populations
- Impaired Renal/Hepatic Function
- Healthy Elderly
- Metabolic Syndrome
- Low Testosterone
We also have a network of partner sites that provide solutions for additional patient populations.
Will you be including the molecular characteristics of the patient’s cancer in inclusion criteria? Are all of the protocol-defined procedures appropriate for collecting data that will support a new drug application or investigational medicinal product dossier? Thoughtful design can aid in defining biomarkers to facilitate later-phase enrollment. We can help you develop novel methods to accelerate proof of concept, determine dose escalation and titration regimens, and adhere to globally consistent quality standards for patient safety and regulatory guidelines.
Our clinic in San Antonio, Texas, was designed specifically for early-phase trials. It is ICH-GCP* compliant, accommodates 300 study participants, and includes all essential facilities for storing and dispensing study drugs and maintaining investigator site files and study data. Specimens are seamlessly transferred for analysis to our bioanalytical lab or a lab of your choice.
Phase I-IIA Therapeutic Portfolio
- Alzheimer’s disease
- Anxiety disorders
- Bipolar disorder
- Cardiovascular disease
- Mild cognitive impairment
- Parkinson’s disease
- Women’s health
*ICH-GCP: International Conference on Harmonisation: Good Clinical Practice