Clinical Trial Monitoring and Management - Project
management, clinical monitoring & site management,
phase I/II services, protocol development, site
selection and training, and meeting planning.
Biostatistics and Data Management - Statistical
design, data management, analysis planning and
programming, statistical interpretation and report
Quality Assurance & Regulatory Affairs - Good
clinical practice (GCP) audits, good laboratory
practice (GLP) audits, medical and scientific
writing, safety monitoring, final report writing,
regulatory document preparation and submission.
Pre-Clinical Services - Pharmacokinetics and
pharmacodynamics, adsorption, distribution, metabolism,
and excretion studies, bioequivalence, toxicology,
methods development and chemical analysis, quality
assurance, and IND filing.