Automated PSUR/PBRER Compilation

Manual PSUR compilation can take weeks and consume hundreds of analyst hours. A blockchain-enabled system automates data aggregation from disparate sources (EHRs, case reports, literature) into a single, immutable audit trail. This reduces the core compilation effort by 70-80%, freeing your pharmacovigilance team for higher-value signal detection and risk assessment. For a mid-sized pharma company, this can translate to annual labor savings exceeding $500,000.

A major cost driver is reconciling conflicting data from global affiliates and CROs. Blockchain's immutable ledger creates a single source of truth for all safety data points, tagged with origin and timestamp. This eliminates reconciliation disputes and the risk of manual transcription errors. The result is a verifiably accurate PSUR that withstands regulatory scrutiny, reducing the risk of costly queries or rejections from agencies like the FDA or EMA.

Regulators demand a complete data lineage. Manually constructing this audit trail is arduous. Blockchain automatically generates an immutable, timestamped record of every data point's journey—from initial report entry through all assessments and updates to final PSUR inclusion. This cuts audit preparation time from days to hours and provides unassailable proof of GVP compliance, significantly de-risking inspections.

Traditional periodic PSURs are retrospective. A live blockchain ledger allows for continuous safety data monitoring. Smart contracts can be configured to flag potential safety signals in real-time based on predefined criteria (e.g., increased reporting frequency for a specific adverse event). This shifts pharmacovigilance from a reactive, report-centric function to a proactive risk management capability, potentially mitigating larger liabilities.

Submitting PSURs to multiple global health authorities requires reformatting and validation. A blockchain-based system can automatically generate submission-ready modules (e.g., CIOMS forms) from the core validated data set. Furthermore, it creates a perpetual, traceable product safety record that simplifies lifecycle management, from clinical trials through post-marketing, enhancing the value of the asset during partnerships or acquisitions.

A European pharmaceutical company piloted a blockchain solution for a single product's PSUR process. The results demonstrated a 65% reduction in data aggregation time and a 90% decrease in time spent on data verification and reconciliation. The audit trail was generated automatically, saving an estimated 120 person-hours per reporting cycle. This pilot provided the ROI justification for a broader enterprise rollout.

The Pain Point: Teams spend weeks manually collecting adverse event data from disparate global sources (clinical trials, post-market surveillance, literature), risking data gaps and transcription errors.

The Blockchain Fix: A permissioned blockchain creates a single source of truth. Data is submitted in real-time from authorized sources (hospitals, regulators, partners) with cryptographic proof of origin and timestamp. The report compiles itself from this immutable ledger, eliminating manual aggregation.

Real Impact: A Top-20 Pharma reduced PSUR compilation time from 6 weeks to 72 hours, freeing up 15,000+ FTE hours annually for analysis, not data entry.

The Pain Point: During regulatory audits, proving the integrity and chronology of safety data is a manual, paper-heavy process. Traceability is often incomplete, raising compliance risks.

The Blockchain Fix: Every data point—from initial report to inclusion in the PSUR—is recorded on-chain with a tamper-proof audit trail. Regulators can cryptographically verify the provenance, timestamp, and custody of every piece of evidence in minutes, not days.

Real Impact: Companies using this model report 90% faster audit response times and have successfully defended against regulatory queries using the immutable ledger as evidence.

The Pain Point: Safety data is locked in organizational silos (company, CROs, partners), delaying the identification of emerging safety signals. Collaboration is slow and legally fraught.

The Blockchain Fix: A multi-party permissioned network allows secure, auditable data sharing. Partners can contribute to and query the ledger under pre-defined smart contract rules, enabling real-time collaborative signal detection while maintaining data sovereignty and compliance (e.g., GDPR).

Real Example: A consortium of biotechs uses a shared ledger to pool anonymized safety data, improving early signal detection by 40% compared to operating in isolation.

The Pain Point: Significant resources are spent reconciling conflicting data versions between internal teams and external partners before report submission, a process prone to disputes and delays.

The Blockchain Fix: With a shared, immutable record, reconciliation is eliminated. Smart contracts can automate workflows—triggering validation steps, approvals, and submissions once predefined data quality and completeness thresholds are met on-chain.

ROI Calculation: One company eliminated a 10-person reconciliation team and reduced report-related dispute resolution costs by $2.5M annually, achieving full ROI on their blockchain investment in under 18 months.

Eliminate manual data reconciliation from disparate sources (e.g., clinical trials, post-market surveillance, literature). A permissioned blockchain creates a single source of truth where each adverse event report is timestamped and cryptographically sealed.

• Key Benefit: Reduces compilation time by up to 70%, cutting FTE costs and eliminating reconciliation errors.
• Real Example: A consortium using Hyperledger Fabric for safety data reduced audit preparation from weeks to hours.

Automate the PSUR/PBRER lifecycle with self-executing smart contracts. Rules for data lock points, reviewer approvals, and submission deadlines are encoded on-chain.

• Key Benefit: Ensures process compliance, prevents missed deadlines, and provides real-time status visibility to all authorized parties.
• ROI Driver: Mitigates risk of regulatory fines (often millions) and accelerates time-to-submission, protecting revenue.

Move from periodic, batch-based reporting to continuous safety monitoring. Stream data to an on-chain ledger where analytics engines can detect safety signals in near real-time.

• Key Benefit: Proactive risk management, potentially reducing patient harm and associated liability costs.
• Quantifiable Impact: Early signal detection can prevent costly drug withdrawals and post-market study requirements.