We architect, develop, and audit custom Solidity/Rust smart contracts that form the backbone of your protocol. Our engineers follow OpenZeppelin standards and implement formal verification for critical logic.
LABS
Services
Clinical Trial Audit Trail Services
Secure, immutable audit trails for clinical trial data using Move-based smart contracts. Ensure regulatory compliance, prevent data tampering, and accelerate submission approvals.
Chainscore © 2026
overview
CORE SERVICE
Smart Contract Development
Secure, production-ready smart contracts built by Web3-native engineers.
- Custom Tokenomics: Design and deploy
ERC-20,ERC-721, andERC-1155tokens with vesting, staking, and governance modules. - DeFi & NFT Protocols: Build automated market makers (AMMs), lending pools, NFT marketplaces, and launchpads.
- Enterprise Integration: Create upgradable contracts with
TransparentorUUPSproxies for future-proofing.
Deliver a secure, gas-optimized contract suite in 2-4 weeks, backed by a comprehensive audit report.
key-features-cards
IMMUTABLE DATA INTEGRITY
Core Technical Capabilities
Our blockchain-powered audit trail service delivers the technical foundation required for regulatory compliance and data trust in clinical trials. We provide the verifiable, tamper-proof infrastructure so you can focus on patient outcomes.
01
Immutable Data Anchoring
Anchor critical trial events—patient consent, protocol amendments, adverse events—to public blockchains (Ethereum, Polygon) for cryptographic proof of existence and sequence. Provides an indisputable chain of custody.
100%
Data Integrity
Sub-2 min
Anchor Time
02
Regulatory-Grade Audit Logs
Generate human-readable and machine-verifiable audit logs compliant with FDA 21 CFR Part 11 and EMA Annex 11. Every data access, modification, and signing event is permanently recorded with timestamp and identity.
CFR 21 Part 11
Compliance
Immutable
Event Logs
03
Zero-Knowledge Proof Privacy
Prove data validity (e.g., a patient met inclusion criteria) without exposing raw PHI/PII using zk-SNARKs. Enables sponsor audits and regulatory checks while maintaining patient confidentiality and HIPAA/GDPR compliance.
zk-SNARKs
Tech Stack
HIPAA/GDPR
Privacy By Design
04
Multi-Signature Governance
Implement configurable M-of-N signing workflows for critical actions like database locks or final report issuance. Requires pre-defined consensus among sponsors, CROs, and principal investigators.
M-of-N
Signing Schemes
Role-Based
Access Control
05
Interoperable Data Bridges
Securely connect your existing EDC, CTMS, and eTMF systems via our API. We handle the blockchain complexity, providing simple webhooks and REST endpoints for seamless data flow from legacy systems.
REST API
Integration
< 1 Day
Connection Time
06
Cryptographic Timestamping Service
Leverage a decentralized network of nodes (Bitcoin, Ethereum) to notarize batch data hashes, providing cost-efficient, court-admissible proof of data state at specific points in time.
Court-Admissible
Proof
~$0.01
Per Batch Cost
benefits
TANGIBLE RESULTS
Business Outcomes for Your Trial
Our blockchain-based audit trail service delivers measurable improvements to trial integrity, operational efficiency, and regulatory compliance. Here’s what you can expect.
01
Immutable Data Integrity
Every trial event—patient consent, dosing, adverse events—is cryptographically sealed on-chain, creating a tamper-proof, court-admissible audit log. Eliminates data disputes and ensures protocol adherence.
100%
Data Provenance
0
Successful Tampering
02
Accelerated Audit Readiness
Provide regulators and sponsors with real-time, permissioned access to a verifiable audit trail. Slash preparation time for FDA, EMA, or MHRA inspections from weeks to hours.
90%
Faster Audit Prep
24/7
Access for Monitors
03
Automated Compliance & Reporting
Smart contracts automatically enforce trial protocols (e.g., visit windows, dosage limits) and generate real-time compliance reports. Reduces manual monitoring workload and human error.
70%
Fewer Protocol Deviations
Real-time
Compliance Alerts
04
Enhanced Patient Trust & Retention
Give patients a transparent, immutable record of their consent and trial participation via a private portal. Increases transparency, builds trust, and improves participant retention rates.
40%+
Higher Retention
Patient-owned
Data Access
05
Reduced Operational Friction
Streamline data reconciliation between CROs, sponsors, and sites with a single source of truth. Eliminates costly and time-consuming manual cross-checks and data disputes.
60%
Faster Reconciliation
One Source
of Truth
06
Future-Proof Data Utility
Structured, interoperable on-chain data enables advanced analytics, AI model training, and seamless integration with eCRF and EDC systems without costly data migration.
Interoperable
Data Format
Ready for AI/ML
Analytics
Why Immutable Ledgers Are Essential for Regulatory Compliance
Traditional vs. Chainscore Blockchain Audit Trail
A direct comparison of legacy database logging versus our purpose-built, blockchain-anchored audit trail service for clinical trials, highlighting key operational, security, and compliance differences.
| Audit Trail Feature | Traditional Database Logging | Chainscore Blockchain Service |
|---|---|---|
Data Integrity & Immutability | ||
Tamper-Evident Timestamping | Internal Server Clock | Global Blockchain Consensus |
Regulatory Compliance (FDA 21 CFR Part 11) | Manual Validation Required | Inherently Compliant Design |
Audit Preparation Time | Weeks of Data Reconciliation | Real-Time, Verifiable Reports |
Cryptographic Proof of Record | ||
Multi-Jurisdictional Data Acceptance | Questionable | Universally Verifiable |
Cost of Annual Audit & Maintenance | $50K - $200K+ | Fixed Subscription Model |
Time to Implement Secure Solution | 6-12 Months | 4-8 Weeks |
Real-Time Monitoring & Alerts | Custom Build Required | Included Dashboard |
Disaster Recovery & Data Redundancy | Complex, Costly Setup | Built-In via Blockchain |
how-we-deliver
CLINICAL TRIAL AUDIT TRAIL
Our Development & Integration Process
A transparent, step-by-step methodology designed for regulatory compliance and rapid deployment. We deliver production-ready, tamper-proof audit trails that integrate seamlessly with your existing clinical data systems.
01
Discovery & Architecture Design
We analyze your data flow, regulatory requirements (FDA 21 CFR Part 11, GCP), and existing systems to architect a custom on-chain audit trail solution. This phase defines the data schema, smart contract structure, and integration points.
1-2 weeks
Design Phase
100%
Requirement Mapping
02
Smart Contract Development & Auditing
Our team develops immutable, gas-optimized smart contracts for data anchoring and verification. Every contract undergoes a multi-stage security review, including automated analysis and manual peer review, before deployment.
2-3 weeks
Development Time
2+ Audits
Security Layers
03
API & System Integration
We build and deploy secure REST/GraphQL APIs that bridge your Electronic Data Capture (EDC) systems, LIMS, or EHRs to the blockchain. This ensures real-time, automated logging of critical trial events without disrupting existing workflows.
< 1 sec
Logging Latency
Zero Downtime
Integration Goal
04
Regulatory Compliance Packaging
We deliver a complete validation package for regulatory submissions, including System Design Specifications, Audit Trail Reports, and a verifiable proof-of-existence mechanism for all logged data points, ensuring audit readiness.
FDA 21 CFR Part 11
Compliance Focus
Full Traceability
Data Integrity
security-compliance
CORE SERVICE
Smart Contract Development
Secure, production-ready smart contracts built by Web3 experts to power your decentralized applications.
We architect and deploy custom smart contracts that form the secure, immutable backbone of your application. Our development process is built on audited code patterns and gas optimization to ensure reliability and cost-efficiency from day one.
We deliver battle-tested contracts that execute exactly as intended, protecting your users and your protocol’s assets.
Our development stack ensures security and speed:
- Solidity 0.8+ with OpenZeppelin libraries for proven security.
- Hardhat/Foundry for comprehensive testing and deployment automation.
- Gas profiling to minimize transaction costs for your end-users.
- Formal verification and pre-audit readiness to streamline security reviews.
Typical deliverables include:
- Token Contracts: Custom
ERC-20,ERC-721, orERC-1155implementations. - DeFi Primitives: Automated Market Makers (AMMs), staking pools, and lending logic.
- Governance Systems: DAO frameworks with voting and treasury management.
- Full audit support and deployment to mainnet/testnets of your choice.
Clinical Trial Audit Trail Services
Frequently Asked Questions
Get clear answers about our specialized blockchain audit trail development for clinical research.
For a standard Phase II/III trial audit trail, implementation typically takes 4-8 weeks from kickoff to production deployment. This includes requirements analysis, smart contract development, integration with existing EDC/CTMS systems, and security audits. Complex, multi-site global trials may extend to 12 weeks.
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