# ME-TA ApS

> ME-TA is a Danish contract research organization (CRO) specializing in biostatistics and
> biometric services for pharmaceutical and biotech companies: statistical consulting,
> statistical programming, AI-augmented CDISC deliverables (SDTM, ADaM, Define.xml, TFLs),
> integrated analyses (ISS/ISE), and a validated statistical computing platform.

ME-TA (Martin Eeg + Toni Awwad) was founded from firsthand experience inside pharma statistical
departments at Novo Nordisk and Novartis, with on-site history at Leo Pharma, ALK-Abelló, and
Ascendis Pharma. Track record: 40+ projects delivered, 100,000+ statistical outputs produced.

## Services

- Statistical consulting: senior biostatistician within your team (FSP) or per project —
  Statistical Analysis Plans (SAPs), CSR statistics sections, DSMB support, HTA/pricing dossiers,
  and integrated analyses (ISS/ISE) for regulatory submissions (a core specialisation).
- AI-augmented deliverables: fixed-price statistical programming — TFL packages, CDISC SDTM
  mapping and datasets, CDISC ADaM dataset suites, Define.xml and reviewers guides, delivered as
  portable SAS 9.4 programs.
- Metawebservice platform: a validated statistical computing environment (SCE) — .NET Core API,
  Windows client integrating with local SAS, full audit trail, job scheduling and dependency
  tracking. Details: https://promo.metawebservice.com/

## Compliance

- 21 CFR Part 11 (electronic records), EU Annex 11 (computerised systems), ICH E6(R3) (GCP),
  ICH E9 (statistical principles), GDPR.
- 22-policy version-controlled Quality Management System; auditable by sponsors and regulators.
- Data processing is intra-EEA: https://me-ta.dk/dpa/
- Framework-by-framework conformance map (pharma/GxP, device/IVD, EU AI governance, GDPR):
  https://me-ta.dk/compliance/

## Company

- Legal name: ME-TA ApS · CVR 37265705 · EU VAT DK-37265705
- Address: Agern Alle 5A, DK-2970 Hørsholm, Denmark
- Contact: contact@me-ta.dk
- Partners: Martin Eeg (statistician, MSc Statistics, 20+ years pharma) and Toni Awwad
  (platform architect, SAS programmer, DPO).

## Links

- [Company site](https://me-ta.dk/)
- [How to engage ME-TA](https://me-ta.dk/engage/)
- [Metawebservice platform](https://promo.metawebservice.com/)
- [Sign in to Metawebservice](https://metawebservice.com/)
- [Data processing](https://me-ta.dk/dpa/)
- [Regulatory conformance](https://me-ta.dk/compliance/)
- [QMS policy portal](https://policy.me-ta.dk)
- [Privacy notice — ME-TA SCE desktop client](https://me-ta.dk/privacy/desktop-client/)
- [Uninstall guide — ME-TA SCE desktop client](https://me-ta.dk/privacy/desktop-client/uninstall/)