Case Study: Clinical Trial Reporting and Coordination Platform
challenge
Clinical trial programs were losing time and risking compliance to cross-site data leakage in reports, assignment blockers caused by incomplete participant sign-ups, and recurring report defects such as misaligned headers, missing questions, and timestamp discrepancies. Test data was polluting production exports, consent and adverse-event (AE/SAE) handling needed stronger guardrails, and teams had no fast path for common exceptions like unlocking a skipped survey, triggering a dose-based survey, or logging an out-of-cycle lab result.
solution
Arkenea developed a custom healthcare software, Survey App’s reporting layer for accuracy and audit readiness, hardened identity and access controls, and centralized role-specific workflows. The rebuild added a dedicated Billing Report module, UID-first data visibility, site-scoped downloads, AE/SAE notifications, and configurable survey and lab flows that respect study cadence while reflecting real-world care delivery.
Survey App now gives clinical trial sponsors clean, site-scoped exports that reduce audit risk, faster operations through targeted unlocks and dose-based triggers, and stronger data quality through UID-first design and test-data isolation. Safety responsiveness improved through automated AE/SAE notifications, while role-based access and suspension rules protect protocol integrity throughout the trial lifecycle.
key highlights
Site-Scoped Reporting: A dedicated Billing Report under Sites gives Accounting, Admins, Coordinators, and Site Users site- and study-scoped visibility, with participant-only downloads enforced for Site Users.
Report Data Hygiene: Fixed header alignment, removed variable-name rows and blank columns, restored month-over-month parity, corrected dose logic, and added first-consent-date and survey-completion-date fields – with patient names stripped from PRO reports in favor of UID-based identification.
Consistent Timestamps Across Exports: Normalized timestamps throughout the platform and resolved lab-data time offsets to support clean reconciliation.
Test Data Isolation: Excluded designated test-site data from production exports, with long-term controls to segregate and restrict test data to specific credentials.
Stronger Identity & Safety Guardrails: OTP login with a 30-day “Trust this browser” window, persistent password-rule visibility, and immediate function suspension for flagged patients.
Pharmacy Data Controls: Admins and Site Users can edit pharmacy details, with Surescripts as the preferred path and manual entries tracked separately to preserve data lineage.
Workflow Accelerators: Purpose-built shortcuts – a 24-hour Call-Center-only survey unlock, automatic survey triggers on the Nth drug dose, and an “Out of Cycle” lab-entry path – cut manual overrides without disrupting study cadence.
AE/SAE Notification Engine: Automatic email alerts to the reporting user and a designated safety inbox on save, with configurable answer-choice triggers for adverse events.
Streamlined Assignment & Access: Admins can assign studies to Site Users before sign-up completes, with added email verification and safer participant-email editing controls.
Arkenea helped provide both practical advice and experience that enabled us to launch our website and create complementary mobile applications in a cost effective way while providing ongoing product support into the future. Without Arkenea, this dream would have vanished into oblivion.
