Remote Patient Monitoring Software for Pharma
Remote patient monitoring software built for decentralised and hybrid trials
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
Bring the problem, the current workflow, or the existing code. We reply with a practical next step within one business day.
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The brief
Start with what is not working.
Good software decisions begin with the constraint, not a list of features or a preferred technology.
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?
Plain answer
Remote patient monitoring software for pharma captures patient-reported outcomes and connected-device readings outside the clinic and transmits structured, EDC-ready data to sponsors and CROs. RaftLabs builds custom platforms for decentralised and hybrid clinical trials: Bluetooth device integration, SNOMED and LOINC mapping, HIPAA-compliant storage, and EDC connectivity. Launch a validated v1 in 14 to 18 weeks, then iterate at a fixed cost.
What to remember
- 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 first build (patient app, 2-3 device integrations, and HIPAA-compliant storage) starts around $50,000-$90,000; the full platform with EDC integration and multi-region infrastructure grows to $90,000-$150,000 as the programme scales.
Proof
- shipping production software across healthcare, fintech, and hospitality
- Since 2015
- RaftLabs delivery record
- average client rating across delivered projects
- 4.9/5
- Clutch, verified reviews
- compliant architecture with a 21 CFR Part 11 audit trail
- HIPAA
- Every RaftLabs healthcare build
The shift to decentralised trials and what it demands from data infrastructure
The FDA finalised its guidance on decentralised clinical trials in 2024 (FDA, 2024), formally recognising remote data collection as part of accepted trial design. That moves routine vitals, symptom logs, and patient-reported outcomes out of the site and into the patient's home. Custom remote patient monitoring software fits that shift to your protocol. The patient app, data model, compliance controls, and clinician dashboard get built around your population and your endpoints, not a vendor's fixed configuration.
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
- Week 101
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.
- Weeks 2-502
Terminology and compliance architecture design
SNOMED/LOINC mapping, EDC integration approach, and jurisdiction-specific compliance architecture designed against your protocol.
- Weeks 6-1503
Build and integrate
Patient app, device integration, and clinician dashboard built in parallel, tested against real protocol scenarios.
- Final 2-3 weeks04
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
A track record in healthcare and clinical platforms
We have shipped production software since 2015, including remote patient monitoring, telehealth, and pharma workforce platforms. Real engagements across SaaS, fintech, healthcare, and logistics, not every one published as a named case study.
- 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.
Proof
Case studies
- 01
AI-assisted remote patient monitoring platform
- patients enrolled in 12 weeks
- 150+
- reduction in clinical decision-making time
- 20%
- HIPAA compliance maintained
- 100%
- 02
Grubly processes 10,000+ restaurant orders while saving owners $5,000 in third-party delivery commissions
Grubly lets restaurants own their online ordering channel. 10,000+ orders processed, $5,000 saved in delivery commissions in the first 15 days, and a direct customer relationship that third-party platforms do not allow.- transactions in first 15 days
- $ 10k+
- savings on food delivery commissions
- $ 5k
- zero to launch
- 12 weeks
- 03
Makeover generates photorealistic before-and-after previews that convert more consultations to bookings
Makeover lets service businesses show clients a photorealistic preview of their result on their own photo. Dental, aesthetics, hair, and 40+ other categories use it to convert more undecided consultations.- higher consultation-to-booking conversion
- 35%
- to generate a photorealistic before/after preview
- 60 sec
- service business categories supported
- 40+
Work with us
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.
- 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.
Common 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.
Start with a focused first build: patient iOS and Android app, Bluetooth integration for two or three device types, structured data capture, clinician dashboard, and HIPAA-compliant storage. That entry build typically starts around $50,000 to $90,000. The full platform, once you add EDC integration, EHR connectivity, and multi-region infrastructure, grows to $90,000 to $150,000 as the programme scales.
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