Auditing
Auditing And Audit Prep
If you know all implemented clinical trial regulations and have been confirmed and inspected with regularity, an Audit should be a celebration of your diligence.
Feel confident that you have followed the circuitous route to victory.
However, if a call from an auditor rings through and you need help, contact us and we will guide you through the critical curves in Phases I - IV beit surveillance or For-Cause.
A vast array of audits may be performed which will be contracted within the Scope of necessary Work or ad hoc.
- Audit Prep for Any and All Procedures (SOPs), Processes & Policies
- Contractual Fulfillment
- Data Collection and DM Precision
- GCP and CFR Compliance
- Investigational Product: (Un)-Blinding Fulfilment & Patient Safety
- IT Security Surety Fulfillment
- Laboratory Compliance
- Manual Completeness and Accuracy: Blood, Imaging & IP
- Patient Safety & Well-Being Assurance
- Project Management Review & Restructuring
- SOP Compliance
- Vendor Custody and Oversight: Blood Labs, Imaging & IP
- Vendor Software Utilization compliance
Every aspect of this enterprising business is embedded with profoundly recognized individuals in the biotech and pharmaceutical industries that identify with excellence, accuracy and completeness.
We are well aware of corporate customs in clinical research and we excel at navigating the sometimes dangerous twists and turns on the path for an ordered and quantified outcome.
We take the anxiety off your shoulders and ensure regulations have been followed to ensure patient safety and the precision of data collection.