A practical guide for pharmaceutical and biotech sponsors: which engagement model fits, how vendor qualification runs, what the DPA covers, and how a first project moves from signed agreement to delivered output.
ME-TA is a Danish CRO providing biostatistics and biometric services to pharmaceutical and biotech companies. Two situations bring sponsors to us.
Sponsors without an in-house biometrics function or statistical computing environment. ME-TA delivers the statistical work end to end: statisticians, programmers, validated compute, and the deliverables for your submission.
Sponsors with an established statistical department who need senior capacity. A senior biostatistician or statistical programmer works from within your team, under your processes, as a functional service provider (FSP) or on a project basis.
Track record: 40+ projects delivered, 100,000+ statistical outputs produced.
Choose the model that matches your infrastructure and needs. Models can be combined within one engagement.
A senior biostatistician working from within your team as a functional service provider (FSP), or engaged per project.
Fixed-price statistical programming deliverables, AI-produced and expert-reviewed. AI use on sponsor data applies only by per-engagement election under the DPA's AI addendum.
The work runs on Metawebservice, ME-TA's validated statistical computing environment, with your team as users on the study.
Delivery timelines and quotes are set per engagement, once scope is known. ME-TA does not publish generic turnaround claims.
ME-TA expects to be qualified as a vendor before study data flows, and is set up for that review.
Qualification timelines are governed by the sponsor's own vendor-qualification process; ME-TA does not quote a standard duration.
Every engagement that processes sponsor data runs under a GDPR Article 28 Data Processing Agreement. ME-TA maintains a standard template and tailors it to each engagement; the standard turnaround for the first draft is one business day.
The full picture, with diagrams: How we handle your data.
From signed DPA to first delivered output, for an engagement delivered on Metawebservice. FSP consulting inside your own systems follows your processes instead.
The study is created on Metawebservice, and your users are invited with study-scoped roles and permissions.
Your team uploads inputs through metawebservice.com into the study's own storage path.
ME-TA statisticians and programmers produce the outputs. SAS execution runs as deterministic, validated compute; AI assists only where elected under the AI addendum.
Outputs are versioned, and the audit trail records who accessed what, when.
Deliverables are released to your team through the platform, including the portable SAS 9.4 programs behind them.
For your team's day-to-day use of the platform, see Getting started on the platform.
Statistical consulting is billed hourly or per project. AI-augmented deliverables are quoted as fixed-price packages once scope is known. Platform access is subscribed per study. ME-TA does not publish price lists; request a quote at contact@me-ta.dk.
Yes. Statistical programming deliverables are produced as portable SAS 9.4 programs, so your team can rerun and extend the work in your own SAS environment. The platform is not a lock-in condition for the deliverables.
Yes. ME-TA operates a 22-policy version-controlled Quality Management System, published at policy.me-ta.dk, and is auditable by sponsors and regulators. Email contact@me-ta.dk to schedule an audit or request qualification documentation.
Not by default. The base service is deterministic: human statisticians and validated SAS / R compute, with no AI processing. AI-assisted production is a per-engagement election governed by a dedicated AI addendum to the DPA, with patient and sample data excluded. If you do not elect it, no AI touches the engagement. Details: How we handle your data.
In AWS eu-west-1 (Ireland), under a storage path scoped to your organisation and study, with access enforced by per-session credentials issued for that path only. The client-work data chain is intra-EEA. If AI-assisted production is elected, inference runs on AWS Bedrock in eu-central-1 (Frankfurt).
ME-TA operates a 22-policy version-controlled Quality Management System and a validated data platform, both designed to meet the requirements of ICH E6(R3), ICH E9, 21 CFR Part 11, EU Annex 11, and GDPR.
The engaged sub-processor is AWS EMEA SARL (Luxembourg). The live sub-processor register is published at policy.me-ta.dk and carries a 30-day change notice.
All contact runs through contact@me-ta.dk: project questions, platform support, QA and audit requests, and data-protection matters.
Describe the study or the capacity you need, and we will propose an engagement model and a quote.
Email contact@me-ta.dk