Clinical Data & Operations Integrity
From Compliance to Velocity
In high-stakes clinical research, hidden operational friction and data entropy are the silent killers of ROI. We move beyond standard compliance checklists to perform a forensic-level analysis of your trial’s operational physics.
Leveraging our specialized Clinical Operations, eTMF, and Data Transfer Audits, we identify the specific bottlenecks and data integrity gaps that threaten your timeline. By applying Technology Business Management (TBM) principles, we quantify the hidden costs of these inefficiencies, ensuring your trial data is not just inspection-ready, but a streamlined asset that accelerates database locks.
⚙️ Clinical Ops Audit
Focus: Workflow Friction.
We analyze operational bottlenecks in study startup and maintenance to mitigate timeline risks.
🛡️ eTMF Audit
Focus: Inspection Readiness.
Ensuring your Trial Master File is not just a storage bin, but a structured asset that withstands scrutiny.
💾 Data Transfer Audit
Focus: Migration Physics.
Validating technical fidelity during migrations to prevent entropy, corruption, and data loss.
The Cost of Friction
Time is the single most expensive variable in clinical trials. Our Clinical Operations Audit identifies "dead air"—the unseen lag time between operational steps. We compare your cycle times against industry best-practice benchmarks to reveal where value leaks out of the system.
Days to Site Activation (Benchmark vs. Actual)
The Inspection Gap
Visualizing the delta between "Expected Documents" (Milestone based) and "Actual Filed Documents."
eTMF Health
A trial without a pristine story is a liability. If the "Actual" line lags the "Expected" line, you are accumulating Regulatory Debt.
Data Entropy
Moving data introduces chaos. Whether integrating a merger or migrating legacy systems, we validate the technical fidelity of every byte. Our Data Transfer Audit looks beyond simple row counts to verify semantic integrity.
- ● Clean Transfer: Semantic meaning preserved.
- ● Transformation Error: Date formats, unit conversions.
- ● Data Loss: Dropped records or corrupted foreign keys.
Migration Fidelity Analysis
The TBM Perspective: Cost of Quality
Applying the 1-10-100 Rule to Clinical Data. The cost to fix a data error increases exponentially the longer it remains undetected.
*Bubble size indicates Financial Impact on the study budget.