What you can use right now
Resource Library
Curated TransCelerate, ICH, FDA, EMA references for sponsors.
Trial Budget Calculator
Total trial estimation aligned to industry budget structures.
AVD original SOPs
Sponsor-level SOPs: pharmacovigilance, QMS, protocol development, regulatory submissions, CSR, CSV, sponsor oversight, audit & inspection.
What we are building for sponsors
Sponsor role portal
Role-based access for medical monitors, regulatory, operations, and finance teams. Audit-logged, PHI-controlled access. (Basic email OTP sign-in for Library and Calculator access is live now.)
CRO oversight view
Visibility into CRO duties as defined in the Transfer of Obligations matrix. Performance scorecards. Deviation tracking.
Multi-study budget tracking
Roll-up across active studies. Compare planned vs actual. Identify variance drivers.
Regulatory submission view
Visibility into submission status, agency questions, and response timelines (informational; does not replace your eCTD system).
KRI / QTL dashboards
Quality Tolerance Limit monitoring with threshold-based alerts.
Site relationship view
See which sites are performing across multiple studies; data-informed site selection for future trials.
How sponsors actually use AVD today
Templates and tools available now
Sponsor budget modeling, protocol templates, regulatory submissions, CSR frameworks, and QMS tools.
Sponsor Budget Calculator
Model total trial costs by site, country, phase, FTE, and procedure mix. SC-code aligned. Free first estimate.
Sponsor / CRO Bundle
RFP template, CRO oversight tracker, vendor oversight plan, study startup tracker, enrollment dashboard — $99.
QA & Compliance Pack
Audit agenda, CAPA templates, deviation report, risk assessment, QMS framework — aligned with ICH E6(R3) and ISO 9001.
Inspection Readiness Kit
Mock inspection agenda, evidence request tracker, TMF/eISF review checklist, CAPA response template — $149.
Questions from sponsor medical, regulatory & ops teams
What can sponsors use for free today?+
The Resource Library, the Trial Budget Calculator (free first estimate), and the full set of original AVD SOPs — all live now with email OTP sign-in.
How accurate is the Sponsor Budget Calculator?+
It uses industry-standard medians from published trial budget references to produce directional estimates — useful for early planning or RFP prep, but not a substitute for a formal sponsor budget or CRO bid. Treat it as a starting point, not a final number.
Do the SOPs make us compliant with ICH E6(R3) or 21 CFR Part 11?+
No single template makes an organization compliant. Our SOPs are designed to support HIPAA, GDPR, ICH-GCP, and 21 CFR Part 11-aligned workflows — final compliance depends on validated implementation, executed BAAs/DPAs, access controls, staff training, and audit logs on your end.
Is there a CRO oversight or KRI/QTL dashboard yet?+
Not yet — the sponsor role portal, CRO oversight view, multi-study budget tracking, regulatory submission view, and KRI/QTL dashboards are on our roadmap. What's live today is the self-serve calculator and template library.
How do we start an enterprise engagement?+
Enterprise platform access isn't available through self-serve checkout yet. Send us your portfolio scope and team size and we'll respond within 1-2 business days.
Get started
Use the free resources today. For enterprise platform access, send us a message about your portfolio scope.