The clinical trial platform built for Real-Time Clinical Trials.

In April 2026, FDA announced the Real-Time Clinical Trials initiative, with proofs-of-concept including the AstraZeneca TRAVERSE Phase 2 mantle cell lymphoma trial (with technical partner Paradigm Health) and the Amgen STREAM-SCLC Phase 1b small cell lung carcinoma trial. SmartSource is the platform Validcare uses to deliver Real-Time Clinical Trials today: each stakeholder — Sponsor, Site, Participant, IRB, Regulator — has access to the clinical information relevant to their role, on the cadence the protocol defines. Validcare is operationally aligned with the architecture FDA is piloting industry-wide.

Yes. The SmartSource Clinical Trial Platform was built from the ground up to meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. Every action in the system is logged with a timestamp, user ID, and before/after values, creating a complete and immutable audit trail. Electronic signatures include full attribution and are linked to the specific record being signed. For GDPR compliance, SmartSource includes data subject rights management, consent tracking, data minimization controls, cross-border transfer safeguards, and right-to-erasure support. Data is encrypted both at rest and in transit, with role-based access controls and multi-factor authentication. The platform undergoes regular security audits and maintains validated disaster recovery procedures.

In traditional trials, clinical data originates on paper source documents at the investigator site, then gets transcribed into an EDC system by site staff. Source Data Verification (SDV) exists because regulators need assurance that the EDC data matches the original source. CRAs travel to each site to compare paper records against electronic entries — an expensive, time-consuming process that adds weeks to timelines. The SmartSource™ Clinical Trial Platform collapses SDV scope by making the investigator's original entry the source record. When a physician enters a lab value, adverse event, or assessment directly into SmartSource at the point of care, there is no second document to verify against. The electronic record IS the source. This dramatically reduces site-based and remote SDV expense, reduces CRA travel costs, and accelerates the path to database lock.

The SmartSource™ Clinical Trial Platform handles most clinical trial technology needs natively — CTMS, EDC, eConsent, ePRO/eCOA, randomization, safety management, and document management are all built into a single platform. When integration with external systems is required, SmartSource supports automated data flows with central laboratories for lab result import and reference range flagging, imaging systems via DICOM integration, wearable devices and connected sensors, and sponsor data warehouses. The platform can also interface with external safety databases and regulatory submission systems. Because SmartSource is a unified platform rather than a collection of bolted-together tools, these integrations are cleaner and less error-prone than typical multi-vendor integration architectures.

Investigators access SmartSource through a role-based interface tailored to their clinical workflow. They see their assigned patient visit schedules, case report forms configured for the specific protocol, lab result entry screens with real-time edit checks, adverse event and SAE capture forms, and access to regulatory documents and their digital binder. The system guides investigators through each visit with alerts, reminders, and task-specific instructions. Because data is entered directly during the patient encounter, investigators spend less time on administrative paperwork. Site coordinators see site-level dashboards for enrollment status, pending tasks, and query resolution. Patients access their own portal for ePRO diaries, visit reminders, medication logs, symptom reporting, and eReimbursement—reducing the burden of trial participation. Across all five stakeholders — Sponsor, Site, Participant, IRB, Regulator — the platform exposes the clinical information relevant to each role on the cadence the protocol defines.

SmartSource includes native ePRO and eConsent modules that are fully integrated with the rest of the clinical data. For patient-reported outcomes, participants complete validated instruments—diaries, symptom trackers, quality-of-life assessments—directly on their mobile devices. The platform sends automated reminders, tracks compliance rates, and flags missed entries in real time. For electronic consent, SmartSource supports both remote and in-person consent workflows with version control, multi-language support, and a 24/7 audit trail that records exactly when each participant reviewed and signed each document. Because ePRO and eConsent data flow into the same unified database as investigator-entered data, there are no integration gaps or reconciliation steps between systems.

SmartSource provides live dashboards that update as data enters the system—not the monthly PDF reports compiled from stale exports that traditional CROs deliver. Sponsors see enrollment tracking with screening-to-enrollment rates broken down by site, recruitment funnel visualizations, and enrollment projections based on current trajectories. Data quality dashboards show query rates by site and form, data entry completion percentages, outstanding items, and cleaning status. Safety monitoring includes AE/SAE summaries, regulatory reporting timelines, and medical review queue status. Financial dashboards track budget versus actual spending, milestone achievement, site payment status, and change order history. All reports are accessible via role-based permissions, so the right stakeholders see exactly what they need without information overload.