Our Services

1. Phases I – IV, Oncology, Neurology, Cardiology and Respiratory
2. Regulatory Training: Relevant Codes & Guidelines in Clinical Trials
3. Audits: For Cause and Compliant Surveillance:
1. Patient Rights (21CFR50) and Procedural Conformity
2. Confidentiality Protection throughout
3. Protocol, IB, ICF & Monitoring Plan Compliance
4. Data Collection Management and consistency with DM
5. Vendor Management & Adherence Oversight
6. CTA and RICI Management Plan Fulfillment & Adherence
7. IT Service Protection (21CFR11)
8. SOW agreement protection
4. Project Management Consulting and Support
5. Monitoring: Reclaiming and Recovery
6. Medical Writing: Sponsor, CRO, FDA
7. Training of Clinical Trial Management for all procedures and processes
8. SOP Composing and redevelopment