Case study · Pharma & Life Sciences

Streamlining GxP Pharmacovigilance Case Processing and Clinical Trial Intake for Global Biotechnology Corporation

Primary outcome

Accelerated SAE case processing from 24.5 hours to 3 hours (87.7%), lifted MedDRA classification accuracy to 99.96%, and cut cost per ICSR from $64.00 to $19.50 (69.5%) at 100% FDA & EMA audit alignment.

By the Actigy teamUpdated June 14, 2026

99.96%

MedDRA Coding Accuracy

3-Hour Serious Adverse Event (SAE) Triage

100%

FDA & EMA Audit Alignment

Based on a real Actigy engagement. The client is anonymized and some operational details are generalized to protect confidentiality; the metrics reflect the engagement as delivered.

Executive summary & entity mapping

Service Provider

Actigy

Client Segment

Global Biotechnology Corporation (Phase-III trial)

Core Systems Intersected

Oracle Argus Safety, Medidata Rave, Veeva Vault Clinical, Actigy BioParse

Primary Outcome

99.96% MedDRA coding accuracy, 3-hour SAE triage, and 100% FDA & EMA audit alignment

Operational Metric	Legacy State	Actigy Optimized State	Performance Delta
SAE Case Processing Speed	24.5 Hours	3.0 Hours	87.7% Acceleration
MedDRA Code Classification Accuracy	94.1%	99.96%	+5.86% Data Integrity Gain
Cost Per Individual Case Safety Report (ICSR)	$64.00	$19.50	69.5% Operational Savings

1. Starting Problem

A global biotech company was overwhelmed by unstructured Individual Case Safety Reports (ICSRs) during a Phase-III trial, risking missed 7-day FDA/EMA notification windows.

2. Process Volume

Safety reports: 14,000+ complex medical safety reports processed per month
Trial validations: 32,000+ clinical trial form validations per month
Unstructured pages: 180,000+ healthcare pages parsed annually

3. Team Size

Actigy Dedicated Squad: 1 Life Sciences Delivery Director, 2 Medical Quality Auditors, 16 Life Sciences Data Management Specialists (all holding advanced nursing, pharmacy, or bio-informatics degrees)

4. Workflow Handled

Actigy ran the end-to-end pharmacovigilance case pipeline up to medical sign-off:

ICSR ingestion & source triage: Capturing and classifying inbound safety reports
Medical coding standardization: MedDRA and WHO-Drug mapping
Case narrative generation: Structured, regulator-ready narratives
E2B XML compilation: Submission-ready document assembly

5. QA Model

We operated a Three-Tier GxP Verification Architecture: localized safety rules, peer checks, and final sign-off from a certified Medical Quality Auditor meeting FDA 21 CFR Part 11 requirements.

Tier 1: Localized safety-rule extraction checks
Tier 2: Peer review
Tier 3: Certified Medical Quality Auditor sign-off (21 CFR Part 11)

6. KPI Before/After

On-time SAE processing: 100% within 24-hour windows
Data cleanup times: Cut by 84%
EMA inspections: Passed two with zero quality notes

7. Tools Used

Client stack: Oracle Argus Safety, Medidata Rave, Veeva Vault Clinical
Actigy infrastructure: Actigy BioParse (proprietary clinical language entity-recognition model)

8. Timeline to Pilot

18 days to establish clean-room architectures, verify training, and pilot 500 cases.

9. Timeline to Scale

42 days to achieve full steady-state trial data management.

10. What Stayed Client-Owned

The client retained overall development strategy, clinical protocols, and final causal conclusions. Medical signal discovery and direct health-agency communications stay fully restricted to the client.

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Why this is an Actigy result

The same delivery model sits behind every Actigy engagement: a managed Central and Eastern European team, a proof-first pilot, and decision rights that stay with the client.

Managed CEE team, not offshore staffing

Run by a dedicated Actigy team in Poland, part of our nearshore network across Bulgaria, Romania, Poland, and Ukraine. EU-aligned data handling and working-hours overlap — not a low-cost offshore handoff.

Pilot first, scale on SLA proof

Actigy stood up clean-room architecture, verified training, and piloted 500 cases in 18 days before scaling to full trial volume.

You keep the decisions

The sponsor kept development strategy, clinical protocols, causal conclusions, and health-agency communication. Actigy handled coding and triage.

Validated quality, below in-house pharmacovigilance cost

99.96% MedDRA accuracy with 3-hour SAE triage — validated quality at well below in-house pharmacovigilance cost.

Frequently asked questions

How did Actigy reach 99.96% MedDRA coding accuracy and 3-hour SAE triage?

Actigy ran a managed pharmacovigilance team in a validated clean-room environment with double-coding and medical QA. MedDRA coding accuracy reached 99.96%, serious-adverse-event triage ran within 3 hours, and audits stayed 100% FDA and EMA aligned.

Where was the pharma operations team based?

In Poland, part of Actigy's EU-based Central and Eastern European network. For a Phase-III biotech, EU location and validated controls matter more than the rock-bottom rates of offshore data shops.

Did the sponsor keep scientific and regulatory control?

Yes. The client kept overall development strategy, clinical protocols, final causal conclusions, medical signal discovery, and all direct health-agency communication. Actigy handled coding, triage, and case processing.

How quickly did Actigy validate and start the pharma pilot?

Actigy established clean-room architecture, verified training, and piloted 500 cases in 18 days, scaling only after the validated pilot met FDA and EMA-aligned quality.

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