Software when you want control. People when you want it done.

Yes — all three modes run on the same platform, so switching mid-contract changes who does the work, not your tooling, templates, or audit history. License the platform, co-deliver with our specialists, or hand us the requirement entirely: insource when you have built capacity, and outsource when deadlines stack or a Policy 0070 package lands mid-quarter. Training and AIMWC certification are included with the license, so bringing work back in-house does not mean starting from scratch. Rules, templates, and audit history stay in place, and you keep the same visibility regardless of who is at the keyboard.

Service levels for our transparency managed services are defined per engagement rather than published as one blanket figure, because realistic turnaround depends on volume, document mix, and how much review sits on your side. Once agreed, they are written into the statement of work — typically throughput, review-cycle timing, and query-response windows — so expectations are explicit on both sides and measurable against the audit trail that arrives with every deliverable. We share the current service standards for your type of work during scoping. We would rather commit to a date we can hold than quote a headline turnaround we cannot. Ask us for the standards that apply to your work.

The work is performed from two TrialAssure offices: our U.S. headquarters in Canton, Michigan, and TrialAssure B.V. in Eindhoven, Netherlands. That means EU clients can contract with and be served by an EU entity, with GDPR-aligned handling and a DPA available on request. The work stays inside TrialAssure’s own teams rather than being offshored to unnamed subcontractors, so the specialists who sign off on your documents are our own employees. Processing runs in our Azure-hosted closed system: encrypted in transit and at rest, never shared between customers, and never used to train public models. Details are in the Trust Center.

To date, TrialAssure has delivered more than 8 million pages of documents and 400+ datasets for clinical trial data sharing and regulatory submissions, across 100+ projects for 30 clients. That work spans EMA Policy 0070 and Health Canada PRCI packages, FOIA responses, GDPR- and HIPAA-aligned data-sharing sets, and plain-language summaries — which is why our rule sets and templates are already shaped by packages that have been through regulatory review rather than by theory. These are cumulative delivery volumes, not a license or seat count.

Our anonymization services include risk-based anonymization of documents, datasets, and DICOM images; transparency-ready template development; and formal risk-of-re-identification assessment. A cross-functional team of clinical data analysts, biostatisticians, and medical writers does the work in ANONYMIZE, so a rule set can be applied as batch anonymization across a whole portfolio instead of document by document. Typical deliverables are EMA Policy 0070 and Health Canada PRCI packages, FOIA responses, and clinical trial data sharing sets aligned to GDPR and HIPAA. Nothing ships unreviewed: every transformation is logged and attributable, and a specialist signs off before release. See how ANONYMIZE works.

Our disclosure services cover registration and results posting across 40+ registries from a single dataset, so a study is entered once and mapped to each registry’s fields rather than re-keyed authority by authority. We also calculate disclosure due dates automatically from study milestones, keep amendments and results updates on that schedule, and produce customized reports that surface compliance risks and operational bottlenecks before they turn into late postings. Scope typically covers EU CTR / CTIS, FDAAA 801 and ClinicalTrials.gov, and Health Canada obligations. You keep approval of every posting. More at transparency and disclosure.

We act as your outsourced transparency department. With 15+ years working alongside regulators, registries, and patient advocates, the team sets strategy and SOPs, interprets new guidance, and runs the change management when a policy shift lands on your process. Day to day that means authoring plain-language summaries to guideline, summarizing study data for reporting, managing review cycles and QC, and drafting responses to regulator queries. We advise and draft; your team keeps the decision and the final sign-off, and every document carries its own audit trail. See plain language summaries.