Pharmacovigilance Case Study: 99.96% MedDRA Accuracy

Pharmacovigilance Case Study: 99.96% MedDRA Coding Accuracy

Primary outcome (Actigy BPO-reported)

In an anonymized engagement, Actigy BPO cut serious adverse event (SAE) case processing from 24.5 hours to 3 hours. The team lifted MedDRA coding accuracy to 99.96%. It cut cost per individual case safety report (ICSR) from $64.00 to $19.50, with processes aligned to the client's FDA and EMA requirements.

Results come from anonymized client engagements, are reported by Actigy BPO and are not independently audited. Results depend on scope.

Engagement boundary: this pharmacovigilance case concerns coding, triage, and data quality under a defined sponsor-controlled workflow, not a location-based compliance guarantee.

By Actigy BPO Editorial Team Published June 14, 2026 · Last updated October 25, 2026

99.96%

MedDRA Coding Accuracy

3-Hour Serious Adverse Event (SAE) Triage

69.5%

Lower Cost per ICSR

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

Engagement summary

The safety team processed pharmacovigilance cases and received clinical trial data during a Phase III trial. The client was an anonymized global biotechnology company. Staff used Medical Dictionary for Regulatory Activities (MedDRA) codes under the client's US Food and Drug Administration (FDA) and European Medicines Agency (EMA) requirements.

Delivery model: Managed operations team
Client Segment: Global Biotechnology Corporation (Phase-III trial)
Core Systems Intersected: Oracle Argus Safety, Medidata Rave, Veeva Vault Clinical, Actigy BPO BioParse
Scope delivered: Safety-case processing, MedDRA coding, SAE triage and clinical data checks

The challenge: pharmacovigilance case intake at volume

Unstructured ICSRs overwhelmed a global biotech company during a Phase III trial. The company risked missing the 7-day notification windows in its client-defined FDA and EMA workflow; these are not a general statement of reporting deadlines.

Workflow and monthly volume

The safety-operations team ran the end-to-end pharmacovigilance case pipeline up to medical sign-off. The team worked from Poland.

Process volume

The team handled these volumes:

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

Team

Dedicated delivery team: 1 life sciences delivery director, 2 medical quality auditors and 16 life sciences data management specialists. The specialists all hold advanced nursing, pharmacy or bioinformatics degrees.

Workflow

The team ran four workflow steps:

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

Quality assurance model

The QA team used three levels of good practice (GxP) checks: local safety rules, peer review and a final check by a medical quality auditor. All followed the sponsor's approved procedures. The sponsor kept control of validation requirements and final medical and regulatory decisions.

Tier 1: Localized safety-rule extraction checks
Tier 2: Peer review
Tier 3: Medical quality auditor review under sponsor-approved procedures

Tools

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

What stayed with the client

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

Results

The figures below describe this anonymized engagement, not a forecast for another scope.

Pharmacovigilance results: client baseline and engagement outcome (Actigy BPO-reported)
Operational Metric	Legacy State	Engagement outcome	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

Additional before-and-after key performance indicators (KPIs) (Actigy BPO-reported):

On-time SAE processing: The safety-operations team processed 100% of SAE cases within 24-hour windows.
Data cleanup times: The data team cut cleanup times by 84%.
EMA inspections: The case records two EMA inspections with zero quality notes for this engagement; this does not establish supplier certification.

How the pilot worked

The pilot team validated the workflow before it scaled to full trial volume.

Timeline to pilot

18 days to set up clean-room architecture, verify training and pilot 500 cases.

Timeline to scale

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

Services used

This engagement provided life sciences operations support: pharmacovigilance case processing, MedDRA and WHO-Drug coding, and clinical trial data validation. For the full scope, see BPO for pharmaceuticals and life sciences.

Engagement outcomes (Actigy BPO-reported)

This case describes a pharmacovigilance data team and sponsor-retained scientific and regulatory decisions. Its reported accuracy, processing time, and pilot schedule apply to that engagement.

Poland-based life-sciences team

The safety-operations team worked from Poland. The described training, review stages, access restrictions, and sponsor sign-off need to be assessed as engagement controls, not inferred from geography.

Pilot first, scale on SLA proof

The pilot team established 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. The safety-operations team handled coding and triage.

Reported coding and triage results

The case records 99.96% MedDRA accuracy and 3-hour SAE triage in this case. The reported baseline comparison does not establish the cost or compliance of another sponsor's operation.

Frequently asked questions

How did the safety-operations team reach 99.96% MedDRA coding accuracy and 3-hour SAE triage?

The delivery lead ran a managed pharmacovigilance team in a validated clean-room environment with double-coding and medical QA. The team reached 99.96% MedDRA coding accuracy and triaged serious adverse events within 3 hours. Its processes stayed aligned to the client's FDA and EMA requirements. (Actigy BPO-reported)

Where was the pharma operations team based?

The safety-operations team was based in Poland. The sponsor's review, access, validation, and sign-off requirements must be checked independently of delivery location. This case is not a comparison with other pharmacovigilance suppliers.

Did the sponsor keep scientific and regulatory control?

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

How quickly was the pharma pilot validated and started?

The pilot team established clean-room architecture, verified training and piloted 500 cases in 18 days. The team scaled only after the validated pilot met quality aligned to the client's FDA and EMA requirements. (Actigy BPO-reported)