Remote Patient Monitoring Software for Pharma

The shift to decentralised trials and what it demands from data infrastructure

Sponsors and CROs running decentralised and hybrid trials are moving routine data collection out of the clinic and into the patient's daily environment, reducing site burden and improving retention. The platforms available fall into two camps: enterprise systems with six-figure licences and month-long validation timelines, or generic survey tools that lack the clinical data architecture, regulatory compliance controls, and EDC connectivity a pharma trial actually requires. Custom remote patient monitoring software fits the trial rather than bending the trial to fit the system: the patient app is built around your protocol and population, the data model maps to your clinical terminology and EDC field structure, and HIPAA/GDPR controls are designed in from the start.

  • Patient-facing mobile app with offline capability, medication reminders, and Bluetooth device sync

  • Structured clinical data capture with SNOMED and LOINC terminology mapping, linked to protocol eCRF fields

  • Clinician dashboard with configurable alert thresholds, threshold breach notifications, and site coordinator view

  • HIPAA-compliant encrypted data storage with full audit trail and EDC integration

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The problem

Sound familiar?

  • Trial subjects dropping out because travelling to site for routine vitals collection is too burdensome for a study that could capture that data remotely?

  • Patient-reported outcome data arriving in formats that don't map to your EDC protocol fields and require manual data cleaning before a submission-ready dataset can be produced?

Short answer

Remote patient monitoring software for pharma captures patient-reported outcomes, device readings, and symptom data outside the clinic from a patient-facing mobile app, and transmits structured data to the EDC system and clinician dashboard. RaftLabs builds custom remote patient monitoring platforms for pharmaceutical companies running decentralised or hybrid clinical trials, including Bluetooth device integration, SNOMED and LOINC terminology mapping, HIPAA-compliant data storage, and EDC connectivity. Most builds deliver in 14 to 18 weeks at a fixed cost.

Key takeaways

  • Device readings are validated for biological plausibility and timestamped to the measurement event, not the transmission event, before entering the clinical dataset.
  • Every data field maps to the correct SNOMED CT or LOINC code and links to the corresponding eCRF field, removing the manual terminology mapping step before EDC load.
  • Cross-jurisdiction trials typically use separate regional data stores with only de-identified aggregate data crossing the boundary, satisfying HIPAA and GDPR simultaneously.
  • A focused platform with app, 2-3 device integrations, and HIPAA-compliant storage runs $50,000-$90,000; adding EDC integration and multi-region infrastructure runs $90,000-$150,000.

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Remote patient monitoring delivery, by the numbers

compliant patient data architecture
HIPAA + GDPR
week delivery for remote monitoring platforms
14-18
software products shipped
100+
cost delivery
Fixed

The shift to decentralised trials and what it demands from data infrastructure

Custom remote patient monitoring software fits the trial rather than bending the trial to fit the system, with the patient app, data model, compliance controls, and clinician dashboard all built around your specific protocol.

Capabilities

What we build

  • 01
    Patient-facing mobile app

    Protocol-defined data entry with reminder notifications, medication adherence tracking, Bluetooth sync, and offline mode.

  • 02
    Medical device integration

    Readings validated for biological plausibility, normalised, and timestamped to the measurement event across BP monitors, CGMs, and more.

    Built with
    Bluetooth
  • 03
    Structured clinical data capture

    Fields mapped to the protocol data dictionary and linked directly to eCRF, with out-of-range values flagged as queries automatically.

    Built with
    SNOMED · LOINC
  • 04
    Clinician dashboard

    Configurable alert thresholds with dashboard, email, and SMS breach notifications, and role-based cross-site access controls.

  • 05
    HIPAA-compliant data storage

    Encrypted, region-appropriate hosting with minimum-necessary access controls and an immutable audit log supporting 21 CFR Part 11.

  • 06
    EDC and EHR integration

    Validated data feeds to your primary EDC on a defined schedule, plus FHIR R4 export for site EHR workflows.

    Built with
    Medidata Rave · Oracle Clinical One

How we work

From scope to live monitoring platform

  1. Week 1
    01

    Trial design and data scoping

    We map your trial design, the data you need to capture remotely, and your regulatory requirements. You leave week 1 with a written scope document and a fixed-price quote.

  2. Weeks 2-5
    02

    Terminology and compliance architecture design

    SNOMED/LOINC mapping, EDC integration approach, and jurisdiction-specific compliance architecture designed against your protocol.

  3. Weeks 6-15
    03

    Build and integrate

    Patient app, device integration, and clinician dashboard built in parallel, tested against real protocol scenarios.

  4. Final 2-3 weeks
    04

    Launch and site training

    Site coordinators and clinical monitors trained on the dashboard before full rollout.

Why us

Why sponsors and CROs choose RaftLabs

  • 01
    Senior engineers build what they scope

    The engineers who assess your protocol also build the solution. No bait-and-switch, no offshore handoff after the contract is signed.

  • 02
    Fixed price before development starts

    We scope the work, calculate the cost, and lock it in writing before any development starts.

  • 03
    9 years and 100+ products shipped

    Clients include Vodafone, T-Mobile, Aldi, Nike, Cisco, and Lockheed Martin. Track record building healthcare and clinical trial platforms.

  • 04
    We'll tell you honestly when an enterprise platform fits better

    Custom is the right call for the programmes where it genuinely fits, not by default.

  • 05
    Compliance architecture documented for your regulatory team

    Data flow decisions are recorded so your legal and compliance team can review against your Data Management Plan.

Have a patient monitoring software project?

Tell us your trial design, the data you need to capture remotely, and the regulatory requirements you're working to. We'll scope the right build.

Talk about your patient monitoring project

Related services

Remote Patient Monitoring Software for Pharma, scoped in one call.

Tell us what's broken. Within one business day you get a straight take on cost, timeline, and the right first step. No deck, no pressure.

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Frequently asked questions

Enterprise platforms suit large Phase III programmes with existing contracts and budget for configuration and validation. Custom is typically the right answer for a mid-size sponsor running a focused Phase II study, a CRO building monitoring capability for a specific therapeutic area, or when the protocol's device list, data model, or EDC connectivity doesn't fit standard configuration options.

US trials use HIPAA-compliant architecture with encryption, role-based access, BAAs, and a full audit trail hosted in US-region infrastructure. EU trials layer GDPR requirements on top, including explicit consent capture and EU-region data residency. Cross-jurisdiction trials typically use separate data stores per region with only de-identified aggregate data crossing the boundary.

Yes. We have integrated with Medidata Rave, Oracle Clinical One, and custom EDC systems, either via a direct API integration mapping fields to the corresponding EDC visit and form fields, or via a correctly formatted file-based export for systems using file-based import.

A focused platform covering patient iOS and Android app, Bluetooth integration for two or three device types, structured data capture, clinician dashboard, and HIPAA-compliant storage typically runs $50,000 to $90,000. Adding EDC integration, EHR connectivity, and multi-region infrastructure typically runs $90,000 to $150,000.

Work with us

Tell us what you need. We'll tell you what it would take.

We scope Remote Patient Monitoring Software for Pharma in 30 minutes. You walk away with a clear cost, timeline, and approach. No commitment required.

  • Scope and cost agreed before work starts. No surprises. No obligation.
  • Working prototype within 3 weeks of kickoff.
  • Pay by milestone. You see progress before each invoice.
  • 60-day post-launch warranty. Bug fixes, UI tweaks, and deployment support. No retainer.
  • All conversations are NDA-protected.

Go deeper

Browse our case studies

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