Clinical Research Organization (CRO) services
- PhaseI-IV study capabilities
- Full clinical trial management services
- Functional services:
- General consulting
- Project management
- Medical writing, research and services (protocol development, ICF, IV, reports, publications, white papers, presentations)
- Regulatory services (ethics, CTA, IND, pre-submission meetings)
- Data management
- IP management
- Site selection and management
- Vendor management
- Safety management
- Biostatistics
- Quality management
Clinical trial site services: Apex Trials
- Phase 1-111 study capabilities
- BA/BE, pharmacokinetic, MAD/SAD
- Proof of concept, adaptive design, efficacy
- NHP/dietary supplements, pharmaceuticals
- Adaptive participant: centric facility
- Qualified staff
- Board certified emergency medicinePl
- Medical staff (MDs, NPs)
- Pharmacy staff (QPIC, AQPICs)
- Dedicated teams
- Coordinators, recruitment, laboratory, QC, QA
- Onsite pharmacy
- Level 5 security clearance
- Controlled drugs and substances dealer's license
- Institution wide cannabis research license
- Sample storage at 4°C, -20°C, -80°C
- IP storage (room temperature, refrigerated, frozen)
- In-house PBMC isolation capabilities
- Standard diagnostic equipment
- Access to imaging (X-ray,DEXA, MRI)
- Crash cart
- Environmental monitoring system for all storage areas with automated external alerts
- Back-up power (gas generator)
- In-house ELISA analytical capabilities