We architect and deploy production-ready smart contracts that form the backbone of your protocol. Our focus is on security-first development, gas efficiency, and long-term maintainability.
LABS
Services
Adverse Event Reporting Automation
Chainscore builds automated, immutable pharmacovigilance systems using enterprise blockchain. We integrate smart contracts and oracles to log, verify, and report adverse drug reactions, ensuring tamper-proof compliance with FDA 21 CFR Part 11 and EMA GVP guidelines.
Chainscore © 2026
overview
CORE INFRASTRUCTURE
Smart Contract Development
Secure, gas-optimized smart contracts built by Web3-native engineers.
We deliver battle-tested code with a 100% clean audit record from top firms like CertiK and Quantstamp.
- Token Standards: Custom
ERC-20,ERC-721,ERC-1155, andERC-4626vaults. - DeFi Primitives: Automated Market Makers (AMMs), lending pools, staking mechanisms, and yield aggregators.
- Advanced Logic: Multi-signature wallets, upgradeable proxies using
OpenZeppelin, and cross-chain messaging (CCIP, LayerZero). - Full Lifecycle: Development, testing (
Hardhat/Foundry), deployment, and ongoing monitoring withTenderly.
Our engineers reduce your time-to-market with 2-week MVP sprints while ensuring your contracts are resilient against the latest attack vectors.
key-features-cards
AUTOMATED ADVERSE EVENT REPORTING
Core Components of Our Pharmacovigilance System
Our modular system integrates directly into your clinical workflow, automating case intake, processing, and submission to meet global regulatory deadlines.
01
Intelligent Case Intake Engine
Automated ingestion and triage of adverse events from structured (EHR, EDC) and unstructured (social media, call centers) sources using NLP. Reduces manual data entry by up to 70% and accelerates initial case capture.
70%
Manual Entry Reduction
< 24 hours
Initial Triage
02
Regulatory Rule Engine & MedDRA Coding
Automated application of ICH E2B(R3) and regional regulations (FDA, EMA, PMDA). Integrated MedDRA browser ensures consistent, audit-ready coding, reducing human error in causality assessment and reportability decisions.
ICH E2B(R3)
Compliance Standard
99.5%
Coding Accuracy
03
Automated Submission Gateway
Direct, validated submission to global health authorities (FDA FAERS, EudraVigilance, etc.) and partners. Includes pre-submission validation, receipt tracking, and automated follow-up for queries, ensuring 100% on-time reporting.
100%
On-Time Submission
15+
Authority Gateways
04
Audit Trail & Quality Management Module
Immutable, timestamped audit log for all case actions, from intake to submission. Built-in quality checks and discrepancy management ensure data integrity and streamline internal audits and regulatory inspections.
21 CFR Part 11
Compliant Audit
Real-time
Discrepancy Alerts
05
Signal Detection & Analytics Dashboard
Real-time analytics and visualization of safety data for proactive signal detection. Generate standard (PBRER, DSUR) and ad-hoc reports to identify trends and support risk management planning.
Real-time
Signal Detection
Custom
Report Generation
06
Enterprise-Grade Security & Hosting
Deployed in your AWS/GCP/Azure VPC or as a managed SaaS. Includes SOC 2 Type II certification, end-to-end encryption, and role-based access controls to protect sensitive patient data.
SOC 2 Type II
Certified
HIPAA/GDPR
Compliant
benefits
STRATEGIC ADVANTAGES
Business Outcomes: Beyond Compliance
Automating adverse event reporting with Chainscore delivers more than regulatory compliance. It creates a competitive moat through operational excellence, data integrity, and strategic foresight.
01
Real-Time Risk Intelligence
Transform raw safety data into actionable insights. Our system flags emerging safety signals in real-time, enabling proactive risk management and faster decision-making for your pharmacovigilance teams.
> 90%
Faster Signal Detection
Real-time
Dashboard Alerts
02
Audit-Ready Data Integrity
Every report is immutably logged on-chain, creating a tamper-proof audit trail. Simplify regulatory inspections with verifiable, timestamped proof of submission and data handling.
100%
Immutable Audit Trail
Zero
Manual Reconciliation
03
Operational Cost Reduction
Automate manual data entry, validation, and submission workflows. Reduce FTEs dedicated to repetitive tasks and eliminate errors that lead to costly rework and potential fines.
60-80%
Process Automation
> 40%
Cost Reduction
04
Global Submission Agility
Configure and manage reporting rules for multiple health authorities (FDA, EMA, PMDA) from a single platform. Accelerate time-to-submission for new markets and regulatory changes.
70% Faster
Market Expansion
Centralized
Rule Management
05
Enhanced Partner & CRO Collaboration
Securely share and synchronize safety data with Contract Research Organizations (CROs) and partners via permissioned blockchain nodes, ensuring consistency without data silos.
Single Source
Of Truth
Role-Based
Data Access
06
Future-Proof Compliance Framework
Our modular architecture adapts to evolving regulations like IDMP and ICSR E2B R3. Leverage smart contracts to update business logic without costly system overhauls.
Modular
Architecture
Rapid
Regulatory Updates
Infrastructure Decision Matrix
Build vs. Buy: Adverse Event Reporting Automation
A detailed comparison of the costs, risks, and time investment between developing a custom adverse event reporting system in-house versus leveraging Chainscore's specialized, audited platform.
| Key Factor | Build In-House | Chainscore Platform |
|---|---|---|
Time to Production Launch | 6-12 months | 4-8 weeks |
Initial Development Cost | $250K - $600K+ | $75K - $200K |
Security & Compliance Risk | High (unaudited code, regulatory gaps) | Low (audited, HIPAA/GxP-aligned architecture) |
Ongoing Maintenance & Updates | Requires dedicated 2-3 person team | Fully managed with optional SLA |
Regulatory Audit Readiness | Manual evidence collection, high prep time | Pre-built audit trails & compliance reporting |
Smart Contract & API Security | Your responsibility; requires external audit | Included (OpenZeppelin patterns, formal verification) |
Data Provenance & Immutability | Custom blockchain integration required | Built-in with Ethereum/Polygon anchoring |
Total Cost of Ownership (Year 1) | $400K - $800K+ | $125K - $250K |
how-we-deliver
PROVEN FRAMEWORK
Our Implementation Methodology
A structured, four-phase approach that de-risks development and ensures your adverse event reporting system is secure, compliant, and ready for production.
01
Phase 1: Discovery & Architecture
We conduct a deep-dive workshop to map your specific reporting workflows, data sources, and compliance requirements (e.g., FDA 21 CFR Part 11, EMA E2B). We then design a system architecture that integrates your existing data lakes with on-chain immutability and privacy layers.
2-3 days
Workshop Duration
1 Week
Architecture Plan
02
Phase 2: Smart Contract & Protocol Development
Our engineers build the core smart contracts for immutable event logging, data hashing, and access control using Solidity 0.8+ and OpenZeppelin libraries. We implement zero-knowledge proofs or secure multi-party computation for sensitive data handling as required.
OpenZeppelin
Security Standard
2-4 Weeks
Development Sprint
03
Phase 3: Integration & API Layer
We develop a robust backend service and REST/GraphQL APIs to seamlessly bridge your internal systems (EHR, CRM) with the blockchain layer. This includes data ingestion pipelines, event listeners, and dashboard connectors for real-time monitoring.
99.9%
API Uptime SLA
< 100ms
P95 Latency
04
Phase 4: Audit, Deployment & Handover
Every contract undergoes a formal security audit by a third-party firm. We then manage the deployment to your chosen network (Ethereum, Polygon, private chain) and provide comprehensive documentation, operational runbooks, and team training.
Certik / Quantstamp
Audit Partners
Full Handover
Included
security-compliance
CORE SERVICE
Smart Contract Development
Secure, production-ready smart contracts built by Web3-native engineers.
We architect and deploy custom smart contracts that form the foundation of your protocol. Our development lifecycle includes formal verification, gas optimization, and comprehensive unit testing to ensure security and efficiency from day one.
Deliver a battle-tested, auditable codebase in 4-6 weeks for a standard MVP.
- Protocols:
ERC-20,ERC-721,ERC-1155, custom staking, governance, and DeFi primitives. - Security: Built with
OpenZeppelinstandards and prepared for third-party audits by firms like CertiK or Quantstamp. - Delivery: Full
Solidity/Vypersource code, deployment scripts, and technical documentation.
Adverse Event Reporting
Frequently Asked Questions
Get clear answers on how we automate pharmacovigilance and safety reporting for Web3 clinical trials and digital therapeutics.
A standard implementation for a single study or therapy takes 2-4 weeks from kickoff to production. This includes smart contract deployment, API integration, and team training. Complex, multi-study deployments with custom logic may extend to 6-8 weeks. We provide a detailed project plan within the first 48 hours of engagement.
ENQUIRY
Get In Touch
today.
Our experts will offer a free quote and a 30min call to discuss your project.
NDA Protected
Confidentiality24h Response
Time to ValueDirectly to Engineering Team
No Sales Fluff10+
Protocols Shipped
$20M+
TVL Overall