AAIPharma provides a comprehensive range of Early Clinical Development services. Whether you choose us to execute an individual study or a comprehensive program our team of skilled professionals will work with you from study design to final study report. With our expert team, access to normal healthy and specialty subject populations, and dedicated facilities we can provide you with timely, relevant and high quality information to enable your decision making.
Study Design:
- Full protocol design and writing
- ICF generation, IRB processes in our Scientific Affairs group
- PK Dept for creative study design and analysis
Operations: Tailored Service for Clients:
- Innovator-sized clinic: 300 beds for dedicated attention to your study
- Clinic Review Boards and Teams: overseeing trials, metrics and resources
- First in Human (FIH) ICU ward with telemetry and nearby hospital for subject safety
- Expandable units designed for dosing large cohorts and long term confinement studies
Support: full clinical package:
- On site pharmacy and local safety laboratories
- Clinical monitoring and full regulatory support for all filings
- Data management via client EDC or Oracle-based CRFs
- Dedicated Lead Data Managers
- Biostatisticans providing analysis plans, integrated summaries
- Bioanalytical labs for method development, validation and sample analysis for preclinical and clinical studies
Study Types: ECG intensive studies, FIH, SAD, MAD, SAD/MAD adaptive studies, BE/BA equivalence, PK and PD, Age and Gender comparison, Food and Drug interaction studies, renal and hepatic impairment studies
Populations: large and diverse populations of several million prospective study subjects including: obsese, hyperlipidemic, elderly, postmenopausal, chronic pain, diabetes, COPD, GERD, migraine, P450 specific metabolizers, Renal and Hepatic
Therapeutic Focus: Metabolic, infectious disease, pain, CNS, neurological disorders, dermatology, women's health, respiratory and oncology
