Remote patient monitoring software for pharma

iOS and Android apps are built for patient populations that include a range of ages and technology comfort levels. Patients complete protocol-defined data entry screens, including symptom diaries, quality-of-life questionnaires, and daily check-ins, with configurable reminder notifications that prompt submission at the right time relative to dose or scheduled event. Medication reminders support adherence tracking and link logged doses to the data collected for that time window. Bluetooth sync pulls readings from paired devices without requiring the patient to manually transcribe values. Offline mode stores data locally when the patient has no signal and syncs automatically on reconnection, so field conditions don't create data gaps. The onboarding flow is designed to match the site coordinator's patient training process, reducing the support burden on clinical staff.

Bluetooth integration covers the connected medical devices your protocol specifies, including blood pressure monitors, pulse oximeters, weight scales, continuous glucose monitors, spirometers, ECG patches, and activity trackers from the main clinical-grade and consumer-grade manufacturers. Raw device readings are received, validated for biological plausibility, normalised into a standard data structure, and tagged with the timestamp of the measurement event rather than the transmission event. Device pairing is handled within the patient app with a guided setup flow so patients who aren't technically confident can complete setup without site assistance. Where a protocol requires a specific certified device, we integrate against that device's SDK or Bluetooth profile directly.

Data collection screens are built against the protocol's data dictionary. Each field maps to the correct SNOMED CT or LOINC code so data enters the system in a form that doesn't require manual terminology mapping before it can be loaded into the EDC. eCRF linkage means patient-submitted data populates the corresponding case report form fields rather than sitting in a separate data silo that requires manual reconciliation at data lock. Protocol-defined visit windows, required fields, and permissible value ranges are enforced at the point of entry. Out-of-range values trigger a query flag in the clinician dashboard rather than being accepted silently. Every data entry event is timestamped and recorded with the patient identity so the audit trail supports source data verification.

Site coordinators and clinical monitors see enrolled patients, recent data submissions, pending queries, and alert status in a single view structured around their site management workflow. Alert rules are configured per protocol. A blood pressure reading above a defined threshold, a missed submission day, or a patient-reported symptom score in the red zone each trigger breach notifications delivered to the responsible clinician by dashboard alert, email, or SMS depending on severity. Patient-level data review shows longitudinal trends for each collected variable so the clinical team can distinguish a single anomalous reading from a consistent pattern that warrants intervention. Role-based access gives site coordinators, principal investigators, and sponsor clinical operations staff appropriate views of the data without exposing cross-site patient identifiers where the protocol doesn't permit it.

Patient data is encrypted at rest and in transit using current standards, hosted on compliant cloud infrastructure in the appropriate data residency region for your study: US East or West for HIPAA, EU for GDPR, or multi-region where the trial spans jurisdictions. Access controls enforce the minimum necessary principle: clinical staff see their assigned patients, sponsor monitors see their assigned sites, and no user role has access beyond what the protocol authorises. Every data access event, every query, every modification, and every administrative action is recorded in an immutable audit log with user identity, timestamp, and the before-and-after state of the affected record. This audit architecture supports 21 CFR Part 11 electronic record requirements and the source data verification process that a regulatory inspector would conduct.

Data collected remotely needs to reach the primary EDC system, whether Medidata Rave, Oracle Clinical One, Veeva Vault EDC, or a custom eClinical system, without a manual import step. We build a data feed that transfers validated patient submissions to the corresponding EDC visit and form fields on a defined schedule or in near real time, depending on the protocol's requirements. EHR connectivity provides a read interface where existing patient demographic and clinical history data can pre-populate fields in the monitoring app rather than requiring patients to re-enter information already held in the health record. For trials where site investigators need data pushed into their EHR workflow, we support FHIR R4 data export to the site's system where the site's EHR provides a receiving endpoint.