What you can use right now
Resource Library
Original AVD Clinical regulatory reference guides 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 submission 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.
Ways a sponsor team could use AVD
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 Bundle
RFP template, feasibility questionnaires, sponsor & CRO oversight documents, study startup tracker, and site performance report — 11 documents for $99.
QA & Compliance Pack
Audit agenda, CAPA templates, deviation report, risk assessment, QMS framework — aligned with good clinical practice and quality-management standards.
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 one free SOP or template with a free account. The rest of the SOP library is browsable, with single documents at $9.
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 GCP or electronic-records rules?+
No single template makes an organization compliant. Our SOPs are designed to support HIPAA, GDPR, GCP, and electronic-records-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 2 business days.
CRO capability, sized for the study you're actually running
Not every trial needs a global CRO and a six-figure change-order process. AVD Clinical offers clinical research services as scoped project work — for emerging sponsors, investigator-initiated studies, and programmes that need a specific function covered properly rather than an entire org chart. We are an early-stage provider taking on our first engagements; we will tell you what we can and cannot cover before you contract anything. Delivered by our team as a hands-on pilot service while we build the workflow — this is not a software platform.
What makes us different
Most sponsors' frustration with CROs isn't capability — it's opacity. You get a number without the assumptions, a status without the detail, and a change order when reality arrives.
We work the other way round. Every budget we build shows its formulas, multipliers, and sensitivity range — the same methodology we publish openly on our methodology page. You see what drives the number, so you can challenge it. That's a harder way to sell and a much better way to work.
Feasibility & site selection
Site identification, capability profiling, feasibility distribution and response review, and a shortlist with documented rationale — so your selection decision is defensible, not anecdotal.
Budget development & oversight
Sponsor-level and site-level budgets, per-patient costing, pass-through modelling, screen-failure assumptions, and site budget review. Transparent formulas throughout.
Study startup
Essential document collection, site activation tracking, regulatory binder standards, and startup timeline management — with visibility into what's actually blocking activation.
Documentation & QA support
Protocol-specific SOPs, monitoring plans, oversight trackers, CRO/vendor duty matrices, and inspection-readiness documentation built to your programme.
Who this fits
Emerging biotech running a first or second study · investigator-initiated research needing sponsor-grade rigour · sponsors adding a small indication to a larger programme · teams who need one function covered well rather than a full outsource.
Who this doesn't fit
Global multi-region Phase 3 programmes needing hundreds of sites and full data management infrastructure. If that's you, we'll say so early and point you elsewhere rather than waste your time.
Send us the indication, phase, and what you need covered. We'll come back with a straight answer on fit and an indicative scope.
Our aim: one point of contact, one budget, one conversation.
Running a multi-site study usually means repeating yourself. Separate contract negotiations, separate IRB submissions, separate budgets, separate status calls — and a startup timeline that moves at the speed of your slowest site. The AVD Clinical Site Network is designed to make it one conversation. It is at pilot stage and recruiting its first member sites — talk to us and we will tell you honestly what we can cover today. Delivered by our team as a hands-on pilot service while we build the workflow — this is not a software platform. Matching is done by our team by hand during the pilot — there is no automated matching yet.
The usual way
✗ Six sites, six contract negotiations
✗ Six IRB submissions on six timelines
✗ Six budgets in six formats
✗ Six status calls to chase
✗ Startup gated by the slowest site
What the network is designed to offer
✓ One point of contact across every site
✓ One IRB submission only where the protocol and participating institutions permit central review; many sites will still require local review
✓ One budget, one consistent structure
✓ One status report across all sites
✓ Member sites will train on one shared SOP set as they join
Faster startup
Sites joining the network adopt a shared document and training standard, so activation should not have to be relearned at every location as the network grows. You're not waiting for six sites to each solve the same problem.
Consistent data & process
Member sites will adopt the same SOPs, source documentation standards, and reporting cadence. The intent is to reduce process drift between sites; actual deviation and finding rates always depend on the protocol and the sites running it.
One accountable partner
You have one named contact at AVD Clinical accountable for the engagement, rather than a chain of site coordinators who each have half the picture.
Tell us the indication, target enrolment, and where you need sites. We'll tell you what the network can realistically cover.
We're expanding — tell us where you need us
Our on-site staffing starts on the East Coast; training and Site Network membership are open nationwide today. We're opening further staffing regions based on where demand actually is. If that isn't your area yet, tell us — the regions we hear about most are the ones we open next.
Not in your region yet?
Register your interest and we'll come to you first when we open there — and we'll tell you honestly where you sit in the queue rather than leaving you guessing.
Need something we haven't listed?
Our services grew out of what people asked us for. If you need something adjacent to what's here, ask — we'll either take it on, or tell you straight that it isn't us and point you somewhere better.
Stay in the loop
New regions, new services, and new free templates as they launch. One short email a month, no spam, unsubscribe any time.
Get started
Use the free resources today. For enterprise platform access, send us a message about your portfolio scope.