Integration Philosophy
Work With Your Existing Systems, Not Replace Them
ArcaScience is designed to integrate with your current pharmacovigilance infrastructure — not force you to migrate data or retire systems that already work.
Our API-first architecture supports real-time and batch integration with safety databases, EDC systems, regulatory submission platforms, and enterprise identity management.
No Data Migration Required
ArcaScience connects to your existing data sources via API or scheduled batch processes. Your data stays where it is — we don't require migration or duplication.
Bidirectional Sync
Analysis results, signal detection alerts, and regulatory documents can be written back to your safety database for single-source-of-truth maintenance.
Enterprise Security
All integrations encrypted in transit (TLS 1.3) and at rest (AES-256). SSO, MFA, RBAC, and audit logging for compliance with 21 CFR Part 11.
Five Integration Categories
Comprehensive Coverage of the PV Technology Stack
From case intake through regulatory submission, ArcaScience integrates with every layer of your pharmacovigilance infrastructure.
Safety Databases
Integrate with enterprise pharmacovigilance systems
Argus Safety
Native integration via Argus API. Real-time case intake, automated E2B export, bidirectional signal write-back, MedDRA coding sync.
Argus 8.x and 9.x supported
Vault Safety (Veeva)
REST API integration with Vault Safety. Case data pull, automated narrative extraction, signal alert push, document attachment to cases.
Vault Safety 21R3+ supported
ArisGlobal MultiVigilance
SOAP/REST integration with MultiVigilance and LifeSphere Safety. Case export, aggregate report generation, audit trail sync.
MultiVigilance 8.x+ supported
Oracle Empirica Signal
Database-level integration for data pull. Signal output comparison and validation. Custom query support for ad-hoc analysis.
Empirica 9.x+ supported
TRACKWISE
API integration for medical device adverse event data. MDR/MAUDE format support. Complaint handling workflow integration.
TRACKWISE 17.x+ supported
Custom / Legacy Systems
E2B(R3) XML import for any system. CSV batch upload with field mapping. Database direct-connect for legacy Oracle/SQL Server systems.
Flexible integration options
Clinical Data Systems
Connect to EDC, CDMS, and trial registries
EDC Systems
Medidata Rave, Oracle InForm, Veeva Vault CDMS. Automated AE data pull, SAE reconciliation, SDTM/ADaM dataset import for benefit-risk analysis.
CDISC SDTM/ADaM compliant
ClinicalTrials.gov
Automated study registry data pull. Adverse event reporting table extraction. Protocol-level metadata for contextualized benefit-risk assessment.
NCT number-based lookup
CTMS / Trial Master File
Veeva Vault CTMS, Medidata Clinical Cloud. Protocol amendments, CSR documents, investigator brochure versioning for regulatory submission traceability.
Document version control
Regulatory Submission Platforms
eCTD publishing, XEVMPD, IDMP integration
eCTD Publishing
Direct export to eCTD publishing tools (Liquent, DocuBridge, Extedo). CTD Module 2.5 and 5.3.5 documents formatted for validation and submission.
eCTD v3.2.2 and v4.0 compliant
XEVMPD Integration
EMA Extended EudraVigilance Medicinal Product Dictionary integration. Product registration data pull, EVMPD code assignment, substance/product hierarchy mapping.
EMA XEVMPD format
IDMP / SPOR
ISO IDMP (Identification of Medicinal Products) data model support. EMA SPOR (Substance, Product, Organisation, Referentials) integration for EU regulatory submissions.
ISO 11238/11615/11616 compliant
External Data Sources
Public databases and literature repositories
FAERS (FDA)
Quarterly automated download from FDA Adverse Event Reporting System. Automated deduplication, MedDRA coding, and integration into AS Profiling Base.
Updated quarterly
EudraVigilance (EMA)
Line listing download and processing. E2B(R3) XML parsing. Automated duplicate detection with FAERS for global signal detection.
Monthly updates
PubMed / Embase
Automated literature search with configurable MeSH terms and drug/event keywords. NLP extraction from abstracts and full-text articles.
Weekly literature updates
VigiBase (WHO-UMC)
WHO Global ICSR Database integration for international signal detection. Access via Uppsala Monitoring Centre partnership.
100+ country coverage
RWE Databases
CPRD, Optum, MarketScan, Sentinel. Patient-level data access agreements. OMOP CDM format standardization for comparative effectiveness studies.
OMOP CDM v5.4 compliant
Regulatory Websites
FDA approval packages, EMA assessment reports, PMDA reviews. Automated web scraping and PDF parsing with NLP extraction.
Automated updates
Enterprise Identity & Security
SSO, MFA, RBAC, and audit logging
Single Sign-On (SSO)
SAML 2.0 and OAuth 2.0 / OpenID Connect support. Okta, Azure AD, Ping Identity, OneLogin, Auth0 tested and validated.
SAML 2.0 / OAuth 2.0 / OIDC
Multi-Factor Authentication
TOTP (Time-based One-Time Password), SMS, hardware tokens, biometric authentication. Configurable enforcement by role and IP range.
FIDO2 / WebAuthn support
LDAP / Active Directory
Direct integration with corporate directory services. User provisioning, group-based role assignment, automated deprovisioning on employee exit.
LDAP v3 / AD integration
Role-Based Access Control
Granular permissions at module, project, and data-source level. Pre-defined roles (Admin, Analyst, Reviewer, Viewer) with custom role creation.
Custom role builder
Audit Trail Export
Complete audit log export to SIEM systems (Splunk, QRadar, Sentinel). CSV and JSON format. Real-time event streaming via webhook.
21 CFR Part 11 compliant
Data Residency Options
US (AWS us-east-1, us-west-2), EU (AWS eu-central-1, eu-west-1), Japan (AWS ap-northeast-1). Customer-managed encryption keys (BYOK).
GDPR / HIPAA compliant
Technical Specifications
RESTful API, Batch Processing, HL7 FHIR Support
ArcaScience's integration layer is built on modern, standards-based protocols with comprehensive documentation and SDKs for Python, R, Java, and .NET.
Request Integration Documentation →REST API
RESTful API with JSON payloads. OAuth 2.0 authentication. OpenAPI 3.0 specification with auto-generated client libraries. Rate limiting: 10,000 requests/hour.
Base URL: api.arcascience.com/v2
Batch Processing
SFTP, AWS S3, Azure Blob Storage for file-based integration. Scheduled jobs (daily, weekly, monthly). CSV, XML, JSON, SAS XPT formats supported. File size limit: 5GB.
Supports large dataset uploads
HL7 FHIR Support
HL7 FHIR R4 support for interoperability with EHR systems. AdverseEvent, MedicationAdministration, Patient, Practitioner resources. Bulk data export ($export operation).
FHIR R4 compliant
SOA Architecture
Service-oriented architecture with microservices for each integration type. Independent scaling and failover. 99.9% uptime SLA with automatic retry and error handling.
99.9% uptime SLA
Security & Compliance
All Integrations Encrypted, Audit-Trailed, 21 CFR Part 11 Compliant
Enterprise-grade security controls ensure that all data integrations meet regulatory requirements for pharmacovigilance systems.
Encryption
TLS 1.3 for data in transit. AES-256 for data at rest. Customer-managed encryption keys (BYOK) supported. Hardware Security Module (HSM) key storage.
TLS 1.3 / AES-256
Audit Trail
Every API call, file upload, and data sync logged with timestamp, user, source IP, and result. Immutable audit log with tamper detection. 7-year retention.
21 CFR Part 11 compliant
Regulatory Validation
FDA 21 CFR Part 11, EU Annex 11, GAMP 5 compliant. IQ/OQ/PQ documentation available. Annual security audits by third-party assessors.
FDA / EMA validated
Network Security
VPN and private network connectivity options. IP whitelisting, firewall rules, DDoS protection. AWS PrivateLink and Azure Private Link supported.
Private network connectivity
Data Isolation
Dedicated database instances per customer. No data co-mingling. Logical and physical separation options. Private cloud deployment available.
Dedicated infrastructure
Disaster Recovery
Daily backups with 30-day retention. Geo-redundant storage in multiple AWS/Azure regions. RTO: 4 hours, RPO: 1 hour. Annual DR testing.
RTO: 4h | RPO: 1h