Continuous Vendor Oversight.
Inspection-Ready by Design.
Support ICH E6(R3) & FDA GCP compliance with structured, traceable vendor governance.
Outsourcing clinical activities doesn’t outsource sponsor accountability.
VISION connects vendor governance, risk, issues, actions, audits and supporting evidence in one environment — helping pharmaceutical R&D teams maintain continuous oversight and demonstrate how external partners are managed.
Connected vendor oversight
Oversight doesn’t end when the meeting ends.
ICH E6(R3) & FDA GCP call for appropriate, risk-proportionate oversight of outsourced trial activities.
VISION connects governance plans, meetings, decisions, performance, issues and corrective actions into a continuous, traceable oversight process.
Clear accountability. Documented actions. Inspection-ready evidence.
From study to vendor, category and portfolio — maintain visibility into oversight activities and the evidence of follow-through.
Four capabilities. One connected oversight model.
Govern continuously. Demonstrate compliance. Act on risk.
VISION brings together the workflows, records and intelligence needed for systematic, evidence-based vendor oversight.
01
Govern
Continuous Governance & Accountability
Structure oversight plans, governance meetings and calendar, responsibilities, decisions and actions. Maintain visibility into open obligations and documented follow-through across vendors, studies and categories.
Benefit: Consistent oversight with clear ownership and accountability.
02
Comply
ICH E6(R3) & Inspection Readiness
Connect vendor qualifications, capability evaluations, audits, CAPAs, governance documentation and evidence into a traceable oversight history. Demonstrate what was monitored, what was identified, what decisions were made and how issues were addressed.
Benefit: Maintain inspection-ready evidence and reduce the manual effort of audit and inspection preparation.
03
Anticipate
Risk Management & Corrective Actions
Identify, assess and monitor vendor risks, issues and recurring deviations. Track remediation, ownership and closure to support timely, risk-based intervention.
Benefit: Identify potential oversight gaps earlier and maintain evidence of corrective action.
04
Connect
Connected R&D Vendor Governance
Bring together relevant information from eClinical, quality, sourcing and contract-management systems. Connect QMS quality signals, eTMF documentation, CTMS/EDC operational data and contractual context to create a more complete view of vendor oversight. VISION complements these systems rather than replacing them.
Benefit: Reduce fragmented information and connect operational evidence with governance decisions.
Maestro AI / Embedded intelligence
AI That Understands
Pharmaceutical Vendor Oversight.
Purpose-built intelligence. Grounded in your governance data.
Maestro AI combines pharmaceutical-specific knowledge, governance processes and authorized VISION data to help teams understand vendor risk, oversight activities and compliance evidence.
It can analyze relevant governance records, meeting materials, performance information, issues, audits and supporting documents to generate contextual Insight Reports.
Maestro AI Insight Reports
From governance records and documents to evidence-backed, decision-ready reports.
Less manual consolidation. Greater visibility. More informed oversight.
Ask Maestro AI:
Inspection Readiness
“Prepare an oversight and inspection-readiness summary for CRO X, including governance activities, open issues, corrective actions and supporting evidence.”
ICH E6(R3) Oversight
“Summarize documented vendor oversight activities and outstanding actions for our Tier 1 CROs.”
Risk & Compliance
“Generate a CRO category risk report covering unresolved issues, audit findings, CAPAs and recurring governance concerns.”
Governance Intelligence
“Create an executive oversight report highlighting vendor performance concerns, overdue actions and decisions requiring management attention.”
Inspection readiness or inspection steadiness?
Be Ready Before the Inspection.
Inspection readiness shouldn’t begin when an inspection is announced.
VISION helps sponsors maintain a connected history of vendor qualification, governance, monitoring, risk assessments, decisions and corrective actions.
With continuous oversight, traceable records and Maestro AI-powered intelligence, teams can retrieve relevant evidence, understand outstanding issues and prepare more efficiently for audits and inspections.
The business value
The Business Value
Demonstrate Oversight
Maintain evidence of vendor monitoring, decisions and follow-through.
Strengthen Compliance
Support consistent, risk-based oversight aligned with ICH E6(R3).
Reduce Inspection Burden
Spend less time gathering records and reconstructing governance history.
Identify Gaps Earlier
Surface unresolved issues, recurring risks and overdue actions before they escalate.
Protect Study Execution
Address vendor performance and compliance concerns before they create broader operational consequences.
The platform
Three pillars. One connected view.
01
Category Management
Know your vendor ecosystem.
- Vendor capabilities and history
- Qualification and segmentation
- Category strategy
- Better sourcing decisions
03
KPIs & Performance
Turn data into decisions.
- KPIs and scorecards
- Trends and benchmarks
- Performance signals
- Early alerts and opportunities