Vendor oversight, data quality and inspection readiness.
Praveg helps sponsors oversee biometrics vendors, measure clinical data quality and prepare for audits and inspections under ICH GCP E6(R3), GCDMP and 21 CFR Part 11. It is for quality, clinical operations and data leaders who need evidence that their data and their vendors are inspection-ready.
Scope of work
Vendor oversight
Oversight plans, KPIs and governance for CRO and technology vendors.
- Vendor capability scorecards
- Oversight plan and metrics
- Escalation and issue management
Data quality
Data quality KPIs, risk-based review and quality tolerance limits.
- Data quality index and dashboards
- Risk-based monitoring inputs
- Critical data and process identification
Audit and inspection readiness
Mock audits, gap assessments and CAPA for data management and biostatistics.
- Readiness assessment against GCP and GCDMP
- Mock inspection and storyboard preparation
- CAPA design and closure
Computerised system compliance
21 CFR Part 11 and validation support for EDC and clinical platforms.
- Validation planning and UAT
- Audit trail review procedures
- Part 11 gap assessment
A good fit when
- Sponsors outsourcing biometrics for the first time
- Quality teams preparing for a sponsor audit or regulatory inspection
- Data leaders who need quality measured, not assumed
Senior, hands-on, accountable
Discovery call
A conversation about the real problem, not only the stated one.
Scoped proposal
Fixed scope, retainer or fractional model, with outcomes named.
Delivery alongside your team
Implementation, not only recommendations; adoption measured.
Handover and sustain
Capability transferred, lighter-touch support thereafter.
Trusted across industries
Praveg provided valuable strategic direction while helping us establish scalable biometrics processes. Their understanding of both operations and technology ecosystems significantly accelerated our setup activities.
The guidance on EDC workflows, role structures, and governance models helped us avoid several costly mistakes during our platform planning phase.
The training sessions bridged the gap between textbook knowledge and industry realities. Participants particularly appreciated the practical examples from live clinical-trial environments.
The Clinical Data Management course content was industry-oriented and extremely relevant for freshers entering the field.
FAQ
What does inspection readiness cover?
A gap assessment against ICH GCP E6(R3), GCDMP and 21 CFR Part 11, a mock audit, storyboard and interview preparation, and a CAPA plan closed before the inspection date.
How do you measure clinical data quality?
Through a defined data quality index covering accuracy, completeness and consistency, tracked per study on a dashboard with quality tolerance limits.
Let’s accelerate together.
Reach out for a discovery conversation, no obligation, just clarity on where structure can unlock speed.