21 CFR Part 11 Compliant • ePRO / eCOA Mobile • CDISC ODM Sync

Clinical Trial Software & ePRO / EDC Engineering

Accelerate biopharma trials and medical device validation. We build decentralized clinical trial (DCT) apps, electronic informed consent (eConsent), tamper-proof audit trails, and automated EDC integrations adhering to FDA 21 CFR Part 11 and GCP guidelines.

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21 CFR Part 11 Certified

GCP / ICH E6(R2) Guidelines

CDISC ODM / SDTM Data Sync

94%+ Protocol Diary Adherence

eTrial Management Engine

21 CFR Part 11 Compliance

FDA Validated

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BYOD / Provisioned ePRO Diaries Offline-first patient symptom surveys, visual analog scales (VAS), and automated reminder push alerts.

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Multimedia eConsent & E-Signatures Interactive video consent modules, comprehension quiz gates, and PKI-based digital signatures.

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Automated EDC Integration Live bi-directional integration with Medidata Rave, Veeva Vault, and REDCap via CDISC ODM APIs.

Decentralized & Hybrid Trials

Clinical Trial Software Engineering Stack

We build research-grade mobile applications, web portals, and data pipelines tailored for CROs, pharmaceutical sponsors, and academic medical centers.

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Validated ePRO & eCOA Scale Engines

Implement standardized questionnaires (EORTC, SF-36, EQ-5D, PHQ-9) with strict response windows, anti-gaming algorithms, and automated investigator alerts.

ePRO / eCOA Response Windows Adherence Nudges

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Immutable Cryptographic Audit Trails

Every keystroke, survey answer edit, and clinician review is cryptographically hashed and logged with UTC timestamps, user IDs, and change reasons meeting 21 CFR Part 11.10.

21 CFR Part 11.10 Cryptographic Hashing Append-Only Logs

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CDISC ODM & EDC Automated Sync

Direct REST/GraphQL adapters translating mobile eSource data into standardized CDISC Operational Data Model (ODM) XML formats for seamless ingestion into Medidata Rave and Veeva.

CDISC ODM XML Medidata Rave Veeva Vault EDC

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Connected Sensor Data Ingestion

Continuous biometrics streaming from wearable actigraphy patches, continuous glucose monitors (CGM), and spirometers, aggregating raw endpoint telemetry for statistical analysis.

Digital Endpoints BLE Actigraphy Continuous Telemetry

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Multimedia eConsent with Audio/Video

Engaging electronic informed consent with multi-language video transcripts, glossary tooltips, and digital signature verification ensuring full IRB / IEC compliance.

IRB Approved UX Version Control E-Signatures

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HIPAA / GDPR Blinded Cohort Access

Role-based investigator and monitor permissions separating double-blind trial coordinators from unblinded statisticians, with field-level PHI de-identification.

Double-Blind Controls Role-Based Access PHI Masking

Clinical Trial FAQs

Frequently Asked Questions About Clinical Trial & ePRO Software

We provide complete Computerized System Validation (CSV) documentation including User Requirements Specifications (URS), Functional Specifications (FS), Traceability Matrices (TM), and executed Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols.

Yes. Our mobile apps use local encrypted SQLite/Realm databases. Patients can complete diaries offline; all entries receive local cryptographic timestamps and automatically synchronize upon network restoration.