Accelerate Drug Development With Custom Pharma Software

Pain Points

• Clinical Trial Data Is Fragmented: EDC systems, lab results, ePRO responses, and site monitoring data live in disconnected silos. Sponsors spend months reconciling data before they can even begin analysis.
• GxP Validation Is Time-Consuming: Every system touching clinical or manufacturing data requires IQ/OQ/PQ validation, 21 CFR Part 11 compliance, and audit trails that add months to deployment timelines.
• Regulatory Submission Complexity: eCTD submissions to FDA, EMA, and PMDA have strict formatting, sequencing, and lifecycle management rules. Manual assembly is error-prone and delays market entry.
• Pharmacovigilance Signal Detection: Post-market safety surveillance requires processing thousands of adverse event reports, detecting signals early, and filing ICSRs within strict regulatory timelines.

Solutions

• Clinical Trial Management Systems: End-to-end CTMS platforms managing study planning, site selection, patient enrollment, monitoring visits, and milestone tracking with real-time sponsor dashboards.
  • Study and protocol management
  • Site feasibility and selection tools
  • Patient enrollment tracking
  • Monitoring visit scheduling
  • Milestone-based payment triggers
• Pharmacovigilance and Safety Platforms: Adverse event intake, case processing, signal detection, and regulatory reporting systems that meet E2B(R3) standards and global submission timelines.
  • AE intake from multiple channels
  • MedDRA coding and case assessment
  • Signal detection algorithms
  • ICSR generation and submission
  • PBRER and PSUR authoring support
• Regulatory Submission Tools: eCTD publishing and lifecycle management platforms that validate structure, manage sequences, and track global submission status across agencies.
  • eCTD Module 1-5 assembly
  • PDF hyperlink and bookmark validation
  • Sequence lifecycle management
  • Multi-region submission tracking

Use Cases

• Clinical Trial Patient Portal — A patient-facing portal for ePRO diary entry, visit scheduling, consent management, medication reminders, and secure messaging with study coordinators. (130-190, $260-$380, 7-9 weeks)
• Adverse Event Reporting System — A pharmacovigilance case management system with AE intake forms, automated MedDRA coding, causality assessment workflows, and E2B(R3) ICSR generation. (150-210, $300-$420, 8-10 weeks)
• Drug Supply Chain Tracker — A serialization and track-and-trace platform for DSCSA compliance, managing unit-level identifiers from manufacturing through dispensing with exception handling. (100-150, $200-$300, 5-7 weeks)

Compliance Notes

• 21 CFR Part 11 electronic records and signatures
• GxP and GAMP 5 validation framework
• ICH E6(R2) Good Clinical Practice
• DSCSA drug supply chain serialization

Frequently Asked Questions

Do you build 21 CFR Part 11 compliant systems?

Yes. We implement electronic signatures, full audit trails, role-based access controls, and system validation documentation packages that satisfy FDA 21 CFR Part 11 requirements.

Can you integrate with existing EDC platforms?

We integrate with Medidata Rave, Veeva Vault CDMS, Oracle Clinical, and other EDC systems via CDISC ODM and REST APIs for seamless clinical data exchange.

How do you handle GxP validation?

We follow GAMP 5 risk-based validation, delivering IQ/OQ/PQ protocols, traceability matrices, and validation summary reports as part of the project deliverables.

Do you support CDISC data standards?

We build systems that capture data in CDASH format and transform it into SDTM and ADaM datasets for regulatory submission, with automated conformance checks.