Sell the outcome. We’ll power the engine.

Yes. You deliver under your own brand and engagement model — the platform is the engine behind your service line, not a competing one. Your templates, your document types, and your sponsor-facing process stay yours; TrialAssure sits underneath and we maintain it. Reseller, referral, and co-delivery arrangements are set out in our partner programs, and you keep the sponsor relationship throughout — we do not go around you to your client. The model already runs in public: Certara has licensed ANONYMIZE inside its own regulatory-science delivery since 2021.

Per-sponsor data separation is built into the platform rather than assembled per project. Each sponsor’s studies, documents, and audit trails stay isolated, and access is scoped to the portfolio it belongs to, so a shared delivery team never means shared data. You can run many client portfolios on one system while keeping each one walled off and independently auditable — which matters when one sponsor audits you and expects to see only its own record. It is a closed, Azure-hosted system with encryption in transit and at rest; client data is never shared between customers and is never used to train public models. TrialAssure is ISO/IEC 27001:2022 certified.

License, reseller, and referral — plus co-delivery for shared engagements and white-glove for overflow. Licensing puts the platform in your hands under your own brand and contract; reseller and referral suit firms that would rather not run the delivery themselves; co-delivery blends your team with ours on a single engagement; white-glove sends us the overflow while you keep the sponsor relationship. You can start with one model and change the mix as your pipeline changes, or use different models for different clients. The options are mapped at partner programs, and our team will match them to how you already contract with sponsors.

For most CROs, yes. Building in-house means months to years of development plus owning every registry and regulatory change forever — from the FDAAA 801 final rule to CTIS — in an area that keeps shifting. Licensing gets you delivering in weeks on a maintained platform where the rules engine tracks 40+ registries and the clocks for you, so your team focuses on the sponsor, not the tooling.

The full lifecycle: registration and disclosure across 40+ registries with REGISTRY, risk-based anonymization for publication with ANONYMIZE, plain language summaries and medical writing in Word with LINK AI, with every sponsor deadline tracked from the same record. In practice that covers what sponsors are handing over now: ClinicalTrials.gov and CTIS postings, EMA Policy 0070 and Health Canada PRCI packages with a quantified re-identification risk position, PLS on the EU CTR’s 12-month clock — 6 months for pediatric trials — in local languages, and CSRs, narratives, and protocols drafted on your templates. One platform means one contract, one audit trail, and one team to train — so you can pitch the sponsor’s whole ask, not a single obligation.

Single-product deployments measure in weeks, not quarters, and scale with the number of products and sponsors involved. Onboarding is mostly configuration rather than construction: we set up your templates and document types, the registries you file to, and per-sponsor separation for each client portfolio, then train your reviewers on the workflow they will actually run. Migration of existing sponsor portfolios is handled as part of onboarding, so you can move live work onto the platform rather than starting only with new studies. More products, more sponsors, or heavier legacy migration lengthen the timeline — we scope that with you before you commit.

Two ways. Platform-rate throughput lets your existing reviewers absorb far more volume than a billable-hours model allows — PLS and anonymization move up to 80% faster and manual anonymization labor drops 50–70% — so many peaks no longer require hiring. When volume outruns your team, route overflow to our co-delivery or white-glove services on demand: we produce the anonymized package, the anonymization report, or the summaries under your engagement and on your timeline. Capacity scales with your book instead of against your margin, and you are not carrying headcount through the troughs.

You do. TrialAssure is AI Enabled. Human Driven.™ — the platform accelerates the work while your writers and reviewers make the decisions and sign off. This is AI as control, not autonomy: validation, source referencing, and an audit trail are visible, so nothing reaches a sponsor deliverable without a person approving it. LINK AI carries per-statement source references back to the underlying document, and anonymization decisions are reviewable before anything is released. Accountability stays with your team, and your sponsor sees a defensible process — which is the point, because you are the one who signed the contract.

Yes. Every output carries a visible trail — what the platform did, what the reviewer approved, and the source behind it — and every transformation is logged and attributable. For anonymization, that includes the quantified re-identification risk and the methodology behind the anonymization report that accompanies the redacted package. For writing, statements trace back to the source document they came from. The controls around that record are independently audited: TrialAssure is ISO 9001:2015 and ISO/IEC 27001:2022 certified. When a sponsor or a regulator asks how a result was produced, the answer is on the record rather than in someone’s memory.

Platform-rate throughput lifts the margin on every study by breaking the link between capacity and headcount. In a billable-hours model, margin is capped and capacity equals headcount; on the platform the same reviewers clear far more pages, PLS and anonymization move up to 80% faster, and manual anonymization labor falls 50–70%, so your cost per document drops while the price you charge the sponsor does not have to. You keep the difference, and each additional study adds margin instead of adding staff. Those figures reflect named TrialAssure engagements and vary by document mix, scope, and delivery model — but the direction holds: transparency becomes a profit center instead of a break-even obligation.

Most offerings are either a point tool for one obligation or a fully outsourced service you resell at someone else’s margin. TrialAssure is the platform behind the service, spanning registration, anonymization, PLS, and medical writing — so you own the delivery, the client relationship, and the economics rather than reselling a black box. It is also the platform 8 of the top 10 clinical development companies use, which shortens the credibility conversation with a sponsor, and Certara already licenses ANONYMIZE inside its own delivery. You compete on your service, not on your tooling.