ME-TA — Martin Eeg and Toni Awwad — deliver TFLs, ADaM, and SDTM with the depth to direct your submission when it matters. Built from firsthand experience inside statistical departments at Novo Nordisk and Novartis, backed by a validated platform and AI-augmented production.
We start as your statistical programmers. When complications arise, we bring the depth to direct the submission.
TFLs, ADaM, SDTM — the hands-on work
When the submission gets complicated
For companies without their own SCE
Autonomous AI agents can now write SAS from specifications, execute programs, read logs, and iterate until clean. But they need infrastructure that supports them. Most pharma SCEs were built for humans working through remote desktops and GUIs — environments where agents cannot operate. Metawebservice is API-first: designed so AI agents and statisticians work side by side on the same platform.
Safety officers, clinical operations, DSMB chairs
Board members meet every three to six months. Between meetings, they return to their full-time roles and lose the thread. When the next data package arrives, they spend hours re-reading the last one to remember what was flagged, what was decided, and what was being watched. The statistician preparing the briefing spends days manually compiling what changed since last time.
Device companies with multiple concurrent studies and high turnover
Someone leaves and takes the study knowledge with them. The new hire inherits a shared folder with hundreds of files and no narrative — no record of what was done, why, or what still needs to happen. The first weeks are archaeology: reading old programs, guessing at intent, occasionally re-doing work that already exists somewhere.
Virtual biotech preparing their first NDA or MAA
The trial succeeded, the deadline is set, and the team is three people who have never built a submission package. A traditional CRO quotes 12–18 months with milestone-only visibility. The CEO asks "are we on track?" every week and nobody can answer until the next quarterly report.
ME-TA operates a comprehensive QMS under ICH E6/E9, 21 CFR Part 11, EU Annex 11, and GDPR. All policies are version-controlled in audit-ready format.
ME-TA commits to notifying affected parties within 4 hours of a confirmed breach — far exceeding the 72-hour GDPR minimum requirement.
All infrastructure changes are deployed through version-controlled code with two-person approval gates before reaching production.
Incident response procedures follow the SANS framework with annual testing to ensure readiness and effectiveness.
Version-controlled policies, complete audit trails, and documented change control. We welcome vendor audits — request an audit slot at any time.
AI makes ME-TA faster, not less secure. Your data stays where you expect it. A dedicated AI Usage Policy (P22) governs all AI activities.
The Metawebservice desktop client runs in a dedicated AI mode where the sync mechanism only downloads SAS programs and reviewed context files. Patient data, datasets, and outputs are never synced to the AI workstation. AI tools on that machine have full local access — because there is nothing sensitive to access. The data boundary is enforced by what the server sends, not by what the AI is told to ignore.
Most SCEs are locked behind GUIs — remote desktops, SAS Enterprise Guide, Citrix sessions. Metawebservice is API-based: 159 REST endpoints covering file operations, SAS job execution, dependency tracking, and audit logging. AI agents can programmatically upload programs, trigger execution, read logs, and download outputs — enabling end-to-end automated workflows that are simply not possible on traditional compute environments.
All AI-generated outputs go through the same two-level QC process as human-generated work. Every deliverable is reviewed by a senior statistician.
Enterprise-grade security built on AWS, designed to satisfy pharma IT and regulatory requirements.
AWS eu-west-1 (Ireland). All data remains within the EEA at all times.
AES-256 encryption at rest. TLS 1.2+ for all data in transit.
AWS Cognito with Email OTP or SSO integration. Frictionless yet secure.
Role-based access with customer-controlled study permissions and project isolation.
AWS CloudTrail plus application-level audit logging. Immutable, tamper-evident records.
Built entirely on AWS managed services. Infrastructure deployed as code with full change control.
A .NET Core API with 159 endpoints purpose-built for clinical biometrics. A Windows client that integrates directly with your local SAS installation. Automated sync, file tracking, execution scheduling, and a complete audit trail — all in one platform.
AI-augmented production, expert-reviewed. Portable SAS 9.4 programs + outputs + validation package. Typically 50-65% below traditional CRO pricing.
GCP CVs available on request.
Agern Alle 5A
DK-2970 Horsholm, Denmark
ME-TA ApS
CVR: 37265705
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