ME-TA is a Danish data processor under GDPR and Danish law. This page describes where your data goes, who sees it, and what is retained where — under which contractual instrument.
Configuration shown: base service.
Configuration shown: base service with AI-assisted production.
TL;DR. A sponsor uploads data through metawebservice.com directly into customer-scoped storage in AWS eu-west-1 (Ireland) under the AWS GDPR Data Processing Addendum. ME-TA operators on company-owned, BitLocker-encrypted PCs run a WinForms client that processes the engagement locally on the PC — work/ (human-actor) and sce/ (machine-only deterministic SAS compute, no AI). Deliverables return to the sponsor through metawebservice.com. Client-work data is stored and processed intra-EEA, and the default transfer path is intra-EEA end to end — no GDPR Chapter V transfer occurs in the standard configuration. The engaged infrastructure sub-processor is AWS EMEA SARL (Luxembourg); the full live register is published at policy.me-ta.dk. Breach-notification commitment: 24 hours to the controller, well inside the 72-hour GDPR maximum.
TL;DR. A sponsor uploads data through metawebservice.com directly into customer-scoped storage in AWS eu-west-1 (Ireland) under the AWS GDPR Data Processing Addendum. ME-TA operators on company-owned, BitLocker-encrypted PCs run a WinForms client that processes the engagement locally on the PC — work/ (human-actor) and sce/ (machine-only deterministic SAS compute). Deliverables return to the sponsor through metawebservice.com. Client-work data is stored and processed intra-EEA, and the default transfer path is intra-EEA end to end — no GDPR Chapter V transfer occurs in the standard configuration. The engaged infrastructure sub-processor is AWS EMEA SARL (Luxembourg); the full live register is published at policy.me-ta.dk. Breach-notification commitment: 24 hours to the controller, well inside the 72-hour GDPR maximum.
AI-assisted production is not part of the base service. It exists only as a per-engagement election, governed by a dedicated AI addendum to the DPA: ME-TA-operated through ME-TA's own client and platform software on EU-region AWS Bedrock or on ME-TA's own self-hosted inference server in Denmark, or sponsor-operated in the sponsor's own approved AI tenant. The inference target is agreed per engagement and stays in the EU on the ME-TA-operated options. The platform carries AI capabilities (AI-knowledge conversion, redaction candidates, a study assistant); under the base service they are not used for the engagement (P22 §22.3.6), and by validated requirement they can reach only those ME-TA-controlled inference paths. In every case: curated operational content only; patient-level data excluded in the standard configuration; no third-party AI tool carries client content; Anthropic is the upstream model author, not engaged as a separate sub-processor on the Bedrock path. See the AI-election section below.
Before the architecture detail below, the four areas a sponsor's IT and procurement function typically check first. Each is grounded in a named control, not an abstract claim.
Cognito user pool with passwordless sign-in: SAML federation to the sponsor's identity provider, configured per sponsor (P07 §7.11.1), or email one-time codes. Session tokens expire within 60 minutes (P07 §7.2).
With federation elected, sponsor users sign in with their corporate credential — no separate ME-TA password to manage, and account lifecycle stays in the sponsor's IdP.
Amazon VPC with private subnets for the data plane; encryption at rest throughout (S3 server-side encryption, Aurora storage encryption, both under AWS-managed keys). Regions: eu-west-1 (storage); AI inference on EU infrastructure when elected.
Amazon VPC with private subnets for the data plane; encryption at rest throughout (S3 server-side encryption, Aurora storage encryption, both under AWS-managed keys). Region: eu-west-1 (storage).
Each sponsor's files are held under a sponsor-scoped storage path, with temporary credentials scoped to one access class of one study. Storage and processing never leave EU regions, and the default upload path is intra-EEA end to end. One disclosed exception exists: an optional client-side accelerated-upload mode (off by default) routes encrypted upload transit via the AWS edge network for throughput; files are stored in the EU in either mode. No Chapter V transfer arises in the standard configuration.
22 effective policies (P01–P22), including AI-usage governance (P22-AI Usage v02, effective 25 AUG 2026); version-controlled; named policy owners; change-control discipline. Covers 21 CFR Part 11, EU Annex 11, ICH E6(R3), GDPR, AI usage.
22 effective policies (P01–P22); version-controlled; named policy owners; change-control discipline. Covers 21 CFR Part 11, EU Annex 11, ICH E6(R3), GDPR.
Audit-traceable; the effective policy set is publicly readable, so reviewers can verify the controls directly rather than request excerpts.
Art. 28 obligations, intra-EEA processing, 24-hour breach notification, dedicated AI-specific addendum, sub-processor changes notified before they take effect (30-day objection window).
Art. 28 obligations, intra-EEA processing, 24-hour breach notification, sub-processor changes notified before they take effect (30-day objection window).
The four substantive procurement gates pre-handled in ME-TA's standard template at policy.me-ta.dk. Each sponsor's executed DPA reflects modifications negotiated with the sponsor's legal function to meet that sponsor's specific requirements; ME-TA's standard template is the opening draft.
Both views of this page rest on the same foundation: a validated, audit-ready statistical computing environment operated by ME-TA statisticians.
The Statistical Computing Environment runs deterministic SAS under a Validation Master Plan and a signed Validation Report (VMP 1-5.1 v05, VR 1-5.3 v02), with evidence records frozen per release; the current released record is SCE 2026.09.2 (08 SEP 2026). Programs, outputs, and logs carry full versioning in customer-scoped S3, with audit-trail metadata on every artifact. AI inference is outside the validated scope (VMP §5.5); the controls that confine it are inside it.
Designed for 21 CFR Part 11 and EU Annex 11 alignment: attributable, contemporaneous, original, accurate records with a reconstructable history. A clause-by-clause mapping (1-5.4 v01) is maintained; validation records are available under NDA or audit rights. Electronic signatures are deployed but not yet exercised on a production record.
Delivery runs under ME-TA's 22-policy version-controlled Quality Management System at policy.me-ta.dk, designed for alignment with: 21 CFR Part 11 · EU Annex 11 · ICH E6(R3) · ICH E9 · GDPR.
Alignment is stated at design level and evidenced through the QMS and the audit trail, not asserted as a certification.
ME-TA statisticians and statistical programmers produce the deliverables; the SCE wraps their work in versioning, execution logs, and audit metadata.
The service is expert statistics; the environment makes every result reproducible and inspectable.
The base engagement runs entirely without AI: human statisticians (WORK) and validated, deterministic SAS compute (SCE), governed by the standard Art. 28 DPA. AI-assisted production is an optional election — governed by a dedicated AI addendum and recorded in the DPA's annex elections. The statistical service and its deliverables are the same either way.
The default posture. ME-TA statisticians and programmers deliver through the human and deterministic-compute stages alone; no AI addendum is attached to the DPA.
None of the AI sections on this page apply — the standard DPA alone governs the engagement.
AI drafting and assistance through ME-TA's own client and platform software (Tier 1 under P22 §22.3.3): the Windows client's AI surfaces call ME-TA's self-hosted inference server on ME-TA's own hardware in Denmark; server-side platform capabilities call EU-region AWS Bedrock or the same self-hosted server. Category A content only, under the AWS GDPR DPA on the Bedrock path. No third-party AI tool carries client content: Claude Code is approved for ME-TA's internal platform development only (approved-tools register F161). This is the AI architecture described in the AI sections of this page.
AI drafting and assistance through ME-TA's own client and platform software (Tier 1 under P22 §22.3.3): the Windows client's AI surfaces call ME-TA's self-hosted inference server on ME-TA's own hardware in Denmark; server-side platform capabilities call EU-region AWS Bedrock or the same self-hosted server. Category A content only, under the AWS GDPR DPA on the Bedrock path. No third-party AI tool carries client content: Claude Code is approved for ME-TA's internal platform development only (approved-tools register F161). This is the AI architecture shown in the AI-enabled view of this page.
Fastest path. ME-TA carries the full AI governance surface and produces the audit evidence.
The AI stage calls the sponsor's own approved AI deployment — for example an Azure OpenAI or AWS Bedrock tenant operated by the sponsor, under the sponsor's identity provider. ME-TA operates none of the inference.
If your AI-usage policy permits only tools approved by your own IT, this election satisfies it by construction — the AI-inference sub-processor drops out of ME-TA's chain entirely.
Whenever AI is elected: a human reviews all AI-assisted output before anything returns to the sponsor, and the AI has no write access to sponsor systems — it drafts, humans decide. The elections apply equally to clinical trials and to clinical investigations / performance studies (MDR / IVDR).
Reading this page: the AI-specific detail (data categories and the AI-assisted workflow loop) sits in the purple ▸ panels below.
The diagrams below refer to Category A and Category B. These are ME-TA's two data classes for AI processing, defined in P22-AI Usage §22.4 and used in the same way in every ME-TA DPA. The same vocabulary runs through SVGs 1–4, the sub-processor schedule, and the AI addendum.
SAPs, protocols, investigator brochures, table/listing/figure shells, SAS/R programs, define.xml, dataset specifications, SOPs and QMS templates, regulatory correspondence (FDA, EMA, notified bodies), reviewed context files, blank CRF templates.
No patient-level data; no trial-subject identifiers. The day-to-day work products of statistical programming and regulatory writing.
Patient-level clinical data (including completed CRFs), randomisation codes, unblinding information, unblinded interim or final results, trial-subject PII (name, DOB, address, hospital/national ID), customer-proprietary data without sponsor-DPA AI permission, US PHI under HIPAA.
A leak here would be a clinical-integrity or compliance event. Excluded from the AI leg in the standard configuration. Where an engagement provides for a capability that must read protected content (redaction, anonymisation), Category B may be processed on ME-TA-controlled inference only, under P22 §22.4.3: confinement to Tier 1, human authority over the result, and cover in the DPA.
Elevated-sensitivity content is a sub-class of Category A where a leak would carry material competitive harm to the sponsor — for example, device-specific failure analyses, post-market surveillance root-cause investigations, or trade-secret methodology. Routes through the same AI inference architecture as other Category A content; additional review gates can be agreed per engagement, and uncertain classifications escalate to the CEO (P22 §22.4).
Standard configuration vs per-engagement. ME-TA's standard offering is the classification above. Sponsors who require a different split — for instance, AI use on a Category-B-class data set under their own DPA and risk-control framework — can have a per-engagement configuration; that is negotiated as a sponsor-specific modification to the standard DPA, not by changing the categories themselves.
The base engagement is four steps — deterministic and human-driven throughout. With an AI election in place, program development is augmented by the AI-assisted loop in the panel below; the data boundaries and the human review gate are identical in both.
The engagement is four steps: deterministic and human-driven throughout, with the human review gate before anything returns to the sponsor.
Datasets, protocol, investigator brochure, SAP, CRF templates, prior submission files — all uploaded by the sponsor through metawebservice.com directly into customer-scoped storage in AWS eu-west-1 (Ireland).
Human work in the WORK stage on the ME-TA-owned, BitLocker-encrypted operator PC — programs, specifications, drafts. Full data access by the engagement-assigned human; nothing leaves the intra-EEA chain.
The SAS programs run on the Statistical Computing Environment — validated, deterministic, no AI present. Full datasets are used here. Outputs and logs are produced.
The SAS programs run on the Statistical Computing Environment: validated and deterministic. Full datasets are used here. Outputs and logs are produced.
The ME-TA data processor reviews the outputs in the WORK stage. Approved deliverables are returned to the sponsor through metawebservice.com.
With an AI election in place, the engagement runs as seven steps from sponsor upload to sponsor deliverable. Steps 4–6 are the SCE ↔ AI iteration loop; the loop runs as many times as the work requires, and only step 7 returns un-redacted material to a human. The data flow in SVG 1 below is this same workflow rendered visually.
Datasets, protocol, investigator brochure, SAP, CRF templates, prior submission files — all uploaded by the sponsor through metawebservice.com directly into customer-scoped storage in AWS eu-west-1 (Ireland). Lands in the WORK stage; nothing has moved to AI yet.
A ME-TA data processor reviews the sponsor's upload and promotes files to the AI stage according to what the per-engagement DPA permits. Typical promoted content: dataset metadata (the schema, not the data itself), redacted confidential documents, specifications, regulatory correspondence — i.e., Category A files per P22 §22.4. The DPA scopes which files may be promoted; ME-TA the data processor performs the review and the promotion. Discretionary human act — no file enters AI without it.
The AI stage drafts SAS programs from the promoted Category A specifications, on the agreed EU inference target. Client-side inference sends prompt content from the operator PC to ME-TA's self-hosted server in Denmark over authenticated TLS; server-side conversion and redaction send document content from eu-west-1 to the same server, or to EU-region Bedrock, which stays inside AWS EU regions. No conversation history is retained across invocations (INF-05-API).
The SAS programs run on the Statistical Computing Environment — validated, deterministic, no AI present, no human in the loop during execution. Full datasets are used here. Outputs and logs are produced.
Log files and redacted outputs flow back to the AI stage as context for the next iteration.
AI revises the SAS programs based on the redacted logs and outputs. Steps 4 → 5 → 6 loop until the programs run clean and produce the expected deliverables.
The ME-TA data processor reviews un-redacted outputs in the WORK stage — full data access by a human, no AI present at this step. Approved deliverables are returned to the sponsor through metawebservice.com.
Election differences: under AI election B, step 3 (and step 6) run against the sponsor's own AI tenant instead of ME-TA's inference path — everything else is identical. With no AI elected, this loop does not run at all; the four-step base workflow above is the whole engagement.
A sponsor's data follows a deterministic path from upload through ME-TA's three-stage architecture and back to the sponsor as deliverables. Every box and arrow below is under contractual coverage of the AWS GDPR DPA or ME-TA's own QMS controls. The AI stage and the Bedrock leg exist only when an AI election is in place (election A shown; under election B the inference target is the sponsor's own tenant; with no AI elected, those elements are absent and the diagram reduces to WORK ↔ SCE ↔ S3).
A sponsor's data follows a deterministic path from upload through ME-TA's two stages (WORK and SCE) and back to the sponsor as deliverables. Every box and arrow below is under contractual coverage of the AWS GDPR DPA or ME-TA's own QMS controls.
End-to-end data flow. The three inter-stage control gates (human-gated promotion, SAS-file submission, automated redaction) are described in the narrative bullets below — this diagram answers "where does data physically go?" only.
End-to-end data flow. The WORK to SCE gate (SAS job submission and results return) is described in the narrative bullets below; this diagram answers "where does data physically go?" only.
meta-cli sync with S3 for sponsor exchange.meta-cli sync with S3 for sponsor exchange.Each transition between stages inside the WinForms client is controlled — by humans, by structural design, or by an automated filter. None of these controls is shown on the diagram above (which answers only "where does data go?"); they are stated here in prose:
The single inter-stage transition in the base service is controlled: the WORK stage submits SAS programs to SCE for deterministic execution, and results return to WORK for human review. Programs, outputs, and logs are synced to customer-scoped S3 with full versioning and audit-trail metadata per the QMS retention policy, independently reconstructable on audit.
Each row below is an actor in or around the data flow. Each column is a class of data. A cell shows the maximum visibility under normal operations; least-privilege controls in our QMS reduce actual visibility further per engagement role.
* ME-TA admin / DPO visibility into clinical content is gated by customer-admin authorisation per P07 §7.10 and P21 §21.8. ME-TA personnel do not readily have access to customer content unless the customer has granted access. Engagement-specific contractors, approved by the customer per P17, act within the ME-TA operator row. Ancillary sub-processors (Microsoft 365 for workforce email and documents, Intune device management and Defender endpoint protection on operator PCs) see endpoint telemetry and contact data only; the full register is at policy.me-ta.dk (P21 §21.11).
What is kept, where it is kept, how long, and under which contractual instrument.
Durations are policy windows (P06 §6.3), not automatic purges: the platform never destroys a record in-app (RS 1-5.2.1 H-19); temporary data may be removed after 1 year in production and 3 years in backups; end-of-engagement return or deletion is executed as a controlled operation on the controller's election (DPA Clause 5.6).
Client-work retention only. ME-TA's internal-only use of consumer-tier Anthropic (no client content) is described in a separate note below.
Client-work retention only.
Separate from anything on the diagram above: ME-TA uses consumer-tier Anthropic (e.g. Claude Max) for internal work only — platform development, internal documentation, learning. No client content ever travels this path, per P22 §22.3.4. Conversations on this path live on Anthropic infrastructure in the United States under Anthropic's Consumer Terms (indefinite until operator-deleted, +30 day backend grace, T&S exception up to 2 years for inputs/outputs and 7 years for classification scores). Anthropic on this path is not a sub-processor of ME-TA — it is ME-TA's own tool vendor for internal-only purposes, with no controller-processor relationship arising.
Sections 1–3 above answer the procurement / DPO questions: where data goes, who sees it, how long it's kept. This section is for the IT-security review: nine specific boundaries the architecture is designed to maintain, the layered controls behind each, and what specifically enforces them. Read it if you are mapping our controls to a security framework (ISO 27001 Annex A, SOC 2 CC, NIST SP 800-53) or running a vendor risk assessment. Controls are stated at design level: the named mechanism per boundary; the as-deployed evidence set for a specific engagement is produced at engagement time. The deployed configuration can also be read by an assessor through a read-only cross-account role (RS 1-5.2.4 AUD-01) without ME-TA's involvement.
Sections 1–3 above answer the procurement / DPO questions: where data goes, who sees it, how long it's kept. This section is for the IT-security review: five specific boundaries the architecture is designed to maintain in the base service, the layered controls behind each, and what specifically enforces them. Read it if you are mapping our controls to a security framework (ISO 27001 Annex A, SOC 2 CC, NIST SP 800-53) or running a vendor risk assessment. Controls are stated at design level: the named mechanism per boundary; the as-deployed evidence set for a specific engagement is produced at engagement time. The deployed configuration can also be read by an assessor through a read-only cross-account role (RS 1-5.2.4 AUD-01) without ME-TA's involvement.
Rows 1–7 restate ME-TA's trust-boundary analysis of the platform (each row a boundary, each cell the enforcing mechanism), governed under the QMS policies published at policy.me-ta.dk (chiefly P07 Systems Access, P21 GDPR, and P22 AI Usage). Rows 8–9 (prompt-injection mitigation; audit log tamper-evidence) are AI-specific and audit-integrity additions per the IT-security review. Requirement IDs (H-12, RET-03, INF-01, L-29 and so on) refer to the signed Requirement Specifications of the validation package.
Rows 1–5 restate ME-TA's trust-boundary analysis of the platform (each row a boundary, each cell the enforcing mechanism), restricted to the boundaries present in the base service and governed under the QMS policies published at policy.me-ta.dk (chiefly P07 Systems Access and P21 GDPR). Requirement IDs (H-12, RET-03, RES-01, LOG-01 and so on) refer to the signed Requirement Specifications of the validation package.
ME-TA's contractual sub-processor chain for client work.
| Sub-processor | Role | Location | Instrument |
|---|---|---|---|
| Amazon Web Services EMEA SARL (Luxembourg) — infrastructure | S3 storage, Aurora (metadata, SAS programs and logs, audit trail), Cognito auth, serverless platform functions (SCE compute runs locally on the operator's PC, so AWS is not a sub-processor for that stage) | AWS eu-west-1 (Ireland) primary; file content replicated to eu-central-1 (Frankfurt); database backups retained 7 days | AWS GDPR DPA (auto-incorporated, Service Terms §1.14.1) |
| Amazon Web Services EMEA SARL (Luxembourg) — AWS Bedrock | AI inference for Category A content, invoked only by ME-TA's platform software (Anthropic Claude models on Bedrock via an EU-only cross-region inference profile; no provider-side retention beyond the request; no training) | AWS EU regions — inference stays in the EU | AWS GDPR DPA (auto-incorporated, Service Terms §1.14.1) |
| ME-TA self-hosted inference server (Denmark) — transparency listing | AI inference for Category A content on ME-TA's own hardware, reached over authenticated TLS by ME-TA's client software and by platform functions in eu-west-1; ME-TA-operated processing, not a third-party sub-processor; listed for transparency (P21 §21.11) | Denmark (ME-TA premises) | ME-TA DPA + AI addendum (ME-TA's own processing) |
| Microsoft Ireland Operations Ltd and other ancillary business sub-processors | Workforce email and documents (Microsoft 365), device management and endpoint protection on operator PCs (Intune, Defender for Business: endpoint telemetry only); engagement administration; no clinical data. Engagement-specific contractors, approved by the customer per P17, are listed in the register. | EU | Microsoft Online Services DPA; supplier DPA or NDA (P05 / P17) |
The AI-inference rows are election-dependent. The Bedrock and self-hosted rows above exist only under AI election A. Under sponsor-operated inference (AI election B) or the no-AI base service, the AI-inference rows drop from the engagement's sub-processor chain entirely — the base chain is the infrastructure row plus ancillary business sub-processors.
Under the AWS Bedrock access pattern, ME-TA's controller's prompts and completions do not flow to Anthropic. AWS hosts the model weights under license from Anthropic and operates the inference service on AWS infrastructure; prompts and completions are not shared with Anthropic. Applying GDPR Art. 4(2) / 4(8) and the EDPB Guidelines 07/2020 factual-nexus test, Anthropic does not factually process ME-TA's controller's data on this path and is therefore not engaged as a processor under Art. 28. The Art. 28 contract is with AWS. Anthropic is the upstream model author — a tool licensor — analogous to Microsoft for Word or the PostgreSQL Global Development Group for AWS RDS for PostgreSQL.
The full rationale, including honest caveats and the procurement walk-through, is available on request as part of the DPA package.
The contractual and policy instruments behind the architecture above.
Auto-incorporated into AWS Service Terms §1.14.1 — covers all AWS-hosted data including Bedrock inference.
Auto-incorporated into AWS Service Terms §1.14.1; covers all AWS-hosted data.
Download PDF →The clause that auto-incorporates the AWS GDPR DPA into every AWS customer agreement.
View on aws.amazon.com →ME-TA's AI policy: AI inference tiers, three-stage architecture, data classification, operator hygiene, AI Act compliance.
View on policy.me-ta.dk →ME-TA's GDPR policy, sub-processor register, encryption framework.
View on policy.me-ta.dk →Sponsor-tailored Article 28 DPA. Sent on request — combines the main DPA and the AI-specific addendum, with sponsor entity details substituted.
Sponsor-tailored Article 28 DPA. Sent on request, with sponsor entity details substituted.
Request via email →Validation Master Plan (1-5.1 v05), Validation Report (1-5.3 v02), 21 CFR Part 11 / EU Annex 11 mapping (1-5.4 v01) and per-release evidence records. Available under NDA or audit rights.
Request via email →Live sub-processor register at policy.me-ta.dk — changes notified before they take effect, with a 30-day objection window, per P21 §21.11.
View on policy.me-ta.dk →We provide an Article 28 DPA tailored to each engagement — entity details, Annex C scope, and AI-addendum elections. ME-TA maintains a standard DPA template and aligns it with each sponsor's requirements.
We provide an Article 28 DPA tailored to each engagement: entity details and Annex C scope. ME-TA maintains a standard DPA template and aligns it with each sponsor's requirements.
Email contact@me-ta.dk