Our Solution / Trials & Real-World Evidence
Trial and real-world evidence generation for advanced therapies, from Phase I through commercial expansion
Current Health supports clinical trials and real-world evidence generation for CAR-T, bispecifics, and other advanced therapies. The same monitoring, clinical team, and data infrastructure can stay with your asset from Phase I through commercial launch, access expansion, and patient support programs, so the evidence stays complete and comparable at every stage.
15+
global clinical trials supported, Phase I to IV
1,500+
advanced therapy episodes
60
peer-reviewed papers and abstracts since 2023
24/7
nurses licensed in all 50 states
From trial to market
Evidence generation across the asset lifecycle
Evidence gathered in early trials carries forward. Showing safe outpatient administration in Phase I to III sets up label expansion. After approval, access expansion and patient support programs generate real-world data for market access, payer, and site-of-care conversations.
Phase I to III
Clinical trials
Monitoring, protocolized escalation, and trial-grade data handling built into your study, with less operational load on sites and participants.
Approval and label expansion
Outpatient safety evidence
Well-characterized, timestamped safety data from outpatient and community administration to support your case for broader settings of care.
Commercial launch
Access expansion and patient support
Sponsor-funded programs that put monitoring and 24/7 clinical cover around patients at more treating sites, including community practices.
Post-launch
Real-world evidence
Consented, deidentified data from those programs, covering safety, utilization, and patient-reported outcomes, with follow-up for late effects.
How we capture the data
Trial and real-world data captured through devices and protocols configured to each therapy
Participants and patients use the Current Health mobile app and, for continuous monitoring, our FDA-cleared wearable, with connected devices where the protocol needs them and a home hub or preconfigured tablet so patients without home Wi-Fi or a smartphone can take part. Everything captured lands on one platform and one timeline.
Current Health wearable
Passively collected physiological signals
Passive capture of pulse rate, SpO₂, temperature, and movement around the clock, with adherence tracked and fit or battery issues flagged automatically.
Current Health mobile app
Patient-reported data from the patient's own phone
ePRO questionnaires, symptom check-ins, scheduled tasks, and reminders, plus a direct line to our nurses. Available in 50+ languages.
Connected devices
Spot-check readings where the protocol calls for them
Blood pressure, weight, spirometry, and temperature readings from connected devices, captured on a schedule set to your protocol.
Home hub and tablet
Accessible to every patient, with or without a smartphone
A home hub supplies its own cellular connectivity, so data flows without home Wi-Fi. Preconfigured tablets are available for patients who don't have or can't use a smartphone.
Safety characterization
More complete adverse event capture, without degrading the safety profile
Continuous monitoring improves the completeness, timing, and characterization of adverse events. It surfaces events earlier without adding events that wouldn't otherwise be recorded, so outpatient administration doesn't create a monitoring artifact in your safety database.
Complete capture1
100%
of care-requiring CRS events were preceded by an alarm and escalated the same day
Patients who did not need care generated no clinical alarms, so the signal comes without added noise for site teams.
No rate inflation2
83% vs. 85%
any-grade CRS, outpatient vs. inpatient, with no significant difference (P = .89)
34% vs. 56%
any-grade ICANS, outpatient vs. inpatient, lower in the outpatient cohort (P = .02)
Continuous monitoring didn't raise recorded event rates. CRS was comparable between settings and ICANS was lower outpatient, so your safety database stays consistent and regulator-ready when administration moves outpatient.
1. Rajeeve S, Wilkes M, Zahradka N, et al. ASH 2025, Abstract 2751. Memorial Sloan Kettering, outpatient bispecific step-up dosing. 2. Battiwalla M, et al. Transplant Cell Ther. 2026. CD19 CAR-T in DLBCL, 143 patients.
Protocol design
Endpoints we help sponsors measure
Continuous signals, structured assessments, and documented clinical events support endpoints at every tier of a protocol. Exploratory endpoints are hypothesis-generating and are shown separately.
Primary
- Time to therapeutic intervention, outpatient vs. inpatient
- Dose optimization support
Secondary
- Incidence and ASTCT grade of CRS and ICANS
- Feasibility and safety of outpatient administration, including OS and PFS, CRS and ICANS rates, and hospital and ICU bed days
- Days alive and out of hospital
- Adverse event onset-time accuracy
- Duration and resolution of CRS
- Cumulative corticosteroid and tocilizumab exposure by detection timing
- Inter-site variance in CRS grading
- Step-up schedule compression
- Protocol deviation rate
Exploratory
Hypothesis-generating
- Continuous physiologic signatures that precede toxicity
- Physiologic changes preceding ASTCT-defining fever
- Individualized, baseline-relative thresholds
- Correlation with cytokine and CRP levels and CAR-T expansion
- Fever burden
- Pre-infusion physiologic baseline as a risk-stratification tool
For HEOR and market access. The same data can support the utilization endpoints payers ask about: hospital and ICU bed days, length of stay, ED visits and unplanned admissions, days alive and out of hospital, and tocilizumab and corticosteroid use. Cost and total-cost-of-care analyses need these outcomes linked to claims or cost data.
ePRO and eCOA
Patient-reported outcomes and symptoms, built into your protocol
We configure, deliver, and monitor ePROs as part of the same platform that captures physiological signals, so what participants report and what their bodies show arrive in one place, on one timeline, and in your EDC.
Configured to your protocol
Validated instruments or your own questionnaires, with customizable questions, branching logic, and delivery cadence matched to visit windows and dosing.
Delivered where participants are
Completed on a smartphone or the Current Health tablet, with reminders and support in 50+ languages for participants with low digital literacy.
Monitored for adherence
Completion is tracked in real time, missed responses trigger alerts, and our nurses follow up so gaps don't become missing data.
Alarms on responses
Responses can trigger clinical alarms against thresholds set in your protocol, just as physiological signals do, so a worsening symptom reaches a nurse right away.
Reviewed and escalated
Our Clinical Coordination Center reviews every alarmed response, contacts the participant, and escalates to investigators when criteria are met. Every alarm, contact, and action is logged with timestamps for investigator review and adverse event assessment, and potential serious adverse events reach the investigator within your protocol's timelines.
Integrated with your data
Timestamped responses flow to your EDC alongside continuous signals, mapped to CDISC standards, with longitudinal trending and reporting for your team.
Symptoms and signals, read together. Structured CRS and ICANS symptom checks, nurse-led virtual ICE assessments, quality-of-life screens, and prodromal symptoms such as chills, fatigue, and headache can all be alarmed. Nurses see each response next to the participant's continuous signals, so a reported symptom and a rising pulse rate are assessed as one picture.
Trial-grade data
Complete, audit-ready data in your EDC
Endpoints and safety signals depend on complete data. We monitor data quality as it arrives, resolve the causes of gaps quickly, and deliver quality-checked data, with a full audit trail, into the EDC you already use.
How we protect data completeness
01
Real-time signal quality monitoring
We monitor signal quality for every participant and flag any issue that affects data availability as soon as it appears.
02
Insight into every data feed
Connection, battery, and waveform quality for each feed, with full signal history and auditable provenance.
03
Automated participant prompts
Wearable issues, such as fit, battery, or connectivity, are classified automatically, and the participant gets a prompt to make a simple fix.
04
Follow-up from our nurses
Unresolved issues go to the Clinical Coordination Center, which follows up with the participant until data is flowing again.
05
Every gap documented
Each gap is logged with its classified cause, such as fit, battery, or connectivity, and adherence is reported as the share of expected data received, so your statisticians can handle missing data as your statistical analysis plan specifies.
Built to fit your protocol
Data exchange
REST API, HL7 FHIR, or SFTP exchange, with no platform lock-in
EDC systems
Vendor-agnostic, including Medidata Rave, Veeva Vault CDMS, Castor, and REDCap
Data standards
Quality-checked, timestamped, and mapped to CDISC standards (CDASH for CRFs, SDTM for submission). Derived values auto-populate CRFs, and full-resolution data arrive as external data transfers.
Sync
Subject IDs, enrollment, and visit windows stay aligned across both systems
Capture
Passive monitoring, connected devices, and ePRO/eCOA through one pipeline
Compliance
21 CFR Part 11 audit trails and e-signatures, HIPAA and GDPR
Certifications
FDA 510(k) cleared (Class II), CE marked (Class IIa), ISO 13485, SOC 2 Type 2, ISO 27001
Post-approval evidence
Evidence from the programs you sponsor
Access expansion and patient support programs put monitoring and 24/7 clinical cover around patients at treating sites. When evidence is designed in from the first patient, the same programs produce consented, deidentified data on how your therapy performs in outpatient and community settings.
Patient support programs
Every patient enrolled adds to the evidence base
Your program handles access. We cover the clinical window after the prescription, and the outcome record from that window shows what the program delivers.
You receive
Outpatient completion, time to detection, alarms resolved without site escalation, utilization, adherence, and patient experience
Access expansion programs
Evidence from every treating site in the program
A sponsor funds monitoring and 24/7 clinical coverage for an agreed number of patients at participating treating sites. We provide monitoring and clinical coordination under each site's protocols, and treating teams keep every clinical decision. With patient consent, we collect physiologic and clinical data alongside routine care.
You receive
Deidentified outcomes evidence for payer and site-of-care conversations, plus quality and experience metrics
What these programs capture
Physiological signals
Passively captured pulse rate, SpO₂, temperature, and movement, plus spot-check respiratory rate, blood pressure, and weight from connected devices.
Patient-reported outcomes
Validated ePRO instruments, symptom check-ins with branching logic, and experience surveys.
Adverse and clinical events
CRS and ICANS with the ASTCT grade from the treating team's record, and other complications, each with the alarm, escalation, and intervention history behind it.
Utilization and outcomes
Hospitalization, ED visits, ICU transfer, length of stay, bed days, and short-term survival over a follow-up window set in the evidence plan.
Adherence and engagement
Wearable adherence, task completion, and response rates.
Patient demographics
Who is being treated outside the hospital, by region and type of site, so you can show who outpatient and community programs reach.
Published evidence
The research behind our evidence model
Our clinical research team works with partner sites and sponsors to publish what we learn, with 60 peer-reviewed papers and abstracts since 2023.
CAR-T · Detection timing
Earlier CRS recognition with continuous monitoring1
7 hrs
median earlier recognition of CRS than standard inpatient nursing care
More precise adverse event onset timing, which supports time-to-intervention and onset-accuracy endpoints.
CAR-T · Risk windows
When CRS and ICANS occur after infusion2
98% · 96%
of CRS and ICANS events, respectively, occurred within the first 15 days
Timing data that helps protocols concentrate monitoring when risk is highest.
Real-world data
Our largest published real-world dataset3
34,000+
patients monitored in routine care across the US and UK, 2019–2024
Continuous physiology, patient-reported outcomes, and clinical events captured outside the hospital.
1. Rajeeve S et al. JCI Insight. 2026;11(12):e203988. Mount Sinai. n=25 evaluable patients. 2. Cox T, et al. Blood. 2024;144(Suppl 1):2300. 209 patients. 3. Wilkes et al. JMIR. 2024.
Explore all our clinical researchPlan evidence generation for your asset
Tell us about your trial or post-approval program, and we'll show you how Current Health fits your protocol, sites, and endpoints.