DEFINED OUTCOMES.
PREDICTABLE PRICING.
Solve common challenges with ready-to-deploy solutions. Perfect for when you know what you need and want a clear, efficient path to achieving it—with no scope creep.
WHY FIXED DELIVERABLES?
Predictable Budget
Fixed pricing with no hourly overruns or scope creep surprises.
Faster Time-to-Value
Proven methodology means faster delivery (4-8 weeks typical).
Proven Methodology
Battle-tested templates and frameworks used by Top 10 pharma.
Ready to Deploy
Customized for your organization but ready to use immediately.
AVAILABLE PACKAGES
RBQM Framework & KRI Library
4-6 weeksA complete set of documentation defining your RBQM governance, processes, roles, and responsibilities, plus a library of ready-to-deploy KRIs with predefined thresholds, visualization specs, and escalation paths.
What You Get:
Ideal For: Organizations establishing foundational RBQM capabilities, sponsors needing standardized documentation, or teams looking to pilot RBQM with a proven framework.
SOP & RBQM Plan Templates
3-4 weeksA suite of ready-to-customize templates for Standard Operating Procedures and study-level RBQM plans, fully aligned with ICH E6(R3) requirements. Includes guidance documents for implementation.
What You Get:
Ideal For: Sponsors needing ICH E6(R3)-compliant documentation quickly, organizations standardizing RBQM processes across studies, or teams preparing for regulatory inspections.
Risk Dashboard MVP
4-6 weeksA functional, Minimum Viable Product of a risk dashboard (in Power BI, Tableau, or R-Shiny) configured with your data and KRIs to demonstrate value, validate requirements, and inform future development.
What You Get:
Ideal For: Organizations piloting RBQM dashboards, sponsors needing proof-of-concept before full implementation, or teams validating requirements with stakeholders.
ICH E6(R3) Readiness Package
5-8 weeksA comprehensive package including a detailed gap assessment report, a prioritized remediation roadmap, updated core quality documentation, and a compliance tracker to ensure full ICH E6(R3) readiness.
What You Get:
Ideal For: Sponsors preparing for ICH E6(R3) compliance deadlines, organizations needing gap assessments before audits, or teams requiring structured remediation plans.
Validation Plan & Documentation Package
4-6 weeksComplete validation documentation for clinical systems, including validation plans, requirements specifications, test scripts, and traceability matrices—ready for QA review and regulatory inspection.
What You Get:
Ideal For: Organizations validating RBQM systems, sponsors needing TMF-ready validation documentation, or teams preparing for regulatory inspections.
OUR PROCESS
Kickoff & Requirements
We gather your specific needs, constraints, and customization requirements (1 week).
Development & Customization
We develop and customize the deliverable based on your requirements (2-4 weeks).
Review & Refinement
You review the deliverable, provide feedback, and we refine as needed (1 week).
Delivery & Handoff
We deliver the final package with training and implementation guidance (1 week).
READY TO GET STARTED?
Schedule a consultation to discuss which package best fits your needs, timeline, and budget. We'll provide a detailed quote and project plan.