FDA / 21 CFR
Regulated clinical trial conduct and inspection-ready records
Sponsor/CRO readiness
Compliance alignment for responsible research operations.
A readiness view centered on FDA-regulated conduct, IRB oversight, GCP, HIPAA safeguards, source documentation, and inspection-ready records.
Sponsor/CRO readiness
Compliance foundation behind responsible research operations.
Research operations are organized around FDA-regulated conduct, IRB oversight, informed consent, investigator accountability, privacy safeguards, source documentation, and inspection-ready records.
Compliance alignment
Icon-style badges highlight the agencies, standards, and review pathways sponsors expect to see before site activation.
ICH Good Clinical Practice
Training, conduct, delegation, and documentation standards
HIPAA Safeguards
Privacy, access control, and protected information handling
NIH Research Guidance
Participant education and human-research awareness
ORI Research Integrity
Responsible conduct, integrity awareness, and research accountability
GDPR Awareness
International privacy considerations when applicable
CCPA / Privacy Rights
Consumer privacy-rights awareness when applicable
PCI Control Awareness
Payment-data controls when payment workflows apply
AICPA / SOC Controls
Operational control discipline for vendor and platform review
Regulatory Governance
- FDA Good Clinical Practice and applicable 21 CFR clinical trial requirements
- IRB review, approval, continuing review, and informed consent oversight
- Investigator CV, medical license, training, financial disclosure, and delegation documentation
- Regulatory binder or eReg structure for audit-ready essential documents
- SOP alignment for protocol conduct, safety reporting, documentation, and closeout
Governing Agency Alignment
Operations can be aligned with sponsor, CRO, IRB, FDA, HHS/OHRP, HIPAA, and study-specific expectations before study conduct begins.
Medisana's clinical foundation supports feasibility and execution when protocol fit, investigator oversight, privacy requirements, and study procedures are aligned.