Who we help / Pharma & Biotech R&D
Safety monitoring & pharmacovigilance for your advanced therapy clinical trials
Our 24/7 nurses and seamlessly integrated technology provide safety monitoring of participants between visits, so community and smaller sites can join advanced therapy clinical trials from Phase I. Every participant adds robust real-world data that captures adverse events earlier without inflating your safety profile, building the case for an outpatient label.
15+
global clinical trials, Phase I to IV
12K+
clinical trial participants
13+
advanced therapy assets supported
60
peer-reviewed papers and abstracts
Across development
How we support your trial, from site activation to safety data
The same safety infrastructure that monitors trial participants outside the clinic also takes operational load off your sites and produces the timestamped safety data behind outpatient protocols, site-of-care decisions, and label expansion studies.
Development
More sites, faster enrollment
Advanced therapy trials tend to stay at a handful of academic centers because few sites can watch participants for serious adverse events around the clock. Our 24/7 safety monitoring and protocolized escalation give smaller and community sites the confidence to take part, so studies reach more participants, closer to where they live.
2–4 wks
to onboard a new site
Approval and label expansion
Build the case for outpatient use before launch
We help sponsors study outpatient and community administration during development, so the evidence for broader settings of care is ready for label and payer conversations, not years after approval. Adverse events are captured earlier and more completely, at rates comparable to inpatient care, so moving outpatient doesn’t penalize the safety profile.
100%
of care-requiring CRS events preceded by an alarm at MSK
Participation
Make participation easier on patients & caregivers
With a nurse a call away 24/7 and monitoring at home between visits, participants and caregivers aren’t on their own after dosing, which makes saying yes to an advanced therapy trial an easier decision.
24/7
nurse access for participants and caregivers, in 50+ languages
Clinical trials
Safety monitoring and data capture for advanced therapy trials
Sponsors have brought us into more than 15 global clinical trials for advanced therapy assets, from Phase I to IV, from outpatient feasibility and label expansion studies to pharmacovigilance in multi-country programs.
80%
of patient issues resolved by our nurses without site escalation
95–97%
task and wearable adherence
Phase III and commercial
CD19 CAR-T
Outpatient administration feasibility to support label expansion
Label expansionPhase III and IV
T-cell engager
Outpatient step-up dosing with alarm-driven monitoring
Label expansionPhase I and II
Multiple myeloma CAR-T
More complete safety data in heavily pretreated patients
PharmacovigilancePhase II and III
T-cell engager
Safety characterization against standard therapies
PharmacovigilanceTherapies we support
Our evidence-based approach is adapted to each asset and safety profile
Nearly half of the advanced therapy pipeline sits outside oncology and hematology. Our scope follows mechanism, not specialty. We support therapies that produce a physiologic signal in a defined at-risk window, where earlier detection changes what happens next. Monitoring intensity, signals, and escalation are configured to each asset’s risk profile.
Hematologic oncology
CAR-T and TCR-T therapies, including autologous, allogeneic, and in vivo. CD3 bispecific and trispecific T-cell engagers. Indications: multiple myeloma, B-cell lymphomas, and B-cell leukemias.
Autoimmune and rheumatology
CD19 and BCMA cell therapies and T-cell engagers moving into autoimmune disease. Indications: lupus and lupus nephritis, systemic sclerosis, myositis, rheumatoid arthritis, and Sjögren’s.
Solid tumor oncology
Antibody-drug conjugates with a known risk of interstitial lung disease, with symptom check-ins, spirometry, and oxygen saturation (SpO₂) tracked between visits, so nurses can escalate for clinical review per protocol.
Rare disease and gene therapy
AAV and ex vivo gene therapies. Indications: sickle cell disease, hemophilia, spinal muscular atrophy, and metachromatic leukodystrophy.
One solution across your portfolio
Build the model once and reuse it for each asset. Sites learn one monitoring standard, one escalation protocol, and one evidence format, and your teams get outcomes that compare across assets, indications, and settings.
Why Current Health
A partner from first trial to commercial scale
One platform across the lifecycle
An FDA-cleared, CE-marked platform that carries a therapy from Phase I trials through commercial delivery.
A published evidence base
60 peer-reviewed papers and abstracts since 2023, with the outpatient model validated across five CAR-T products and multiple sites.
Operations handled for your sites
Our 24/7 Clinical Coordination Center and in-house kit team in Rochester, NY keep care escalation and device management off your site teams.
Built for older, frail patients
Median wearable adherence of 95.3% in patients aged 75+, higher than in younger patients. NHS virtual wards, 857 patients · Pugmire et al., Age and Ageing, 2024.
Regulation and compliance
Complete, audit-ready data, delivered to your EDC
Trial data arrives validated, timestamped, and audit-ready in the EDC you already use, from an FDA-cleared platform built for regulated studies.
Compliance
21 CFR Part 11 audit trails and e-signatures, HIPAA and GDPR
Standards
Validated, timestamped data mapped to CDISC/SDTM
Integration
Vendor-agnostic delivery to your EDC via REST API, HL7 FHIR, or SFTP
Completeness
Live signal-quality monitoring, automated participant prompts, and nurse follow-up when data stops flowing
Device status
FDA 510(k)-cleared wearable and platform (K190073, K191272, K210133, K222550, K231506), CE marked (Class IIa), ISO 13485 certified quality management system
Fit for purpose
Verification and validation documentation, available under NDA, to support your fit-for-purpose assessment under FDA’s guidance on digital health technologies in clinical investigations.
Version control
Firmware and algorithm versions locked for the length of a study, with every version documented for your regulatory submission.
Our research
Built on leading research
Our clinical research team works with leading cancer centers to define, test, and publish how advanced therapies can be delivered safely outside the hospital, with 60 peer-reviewed papers and abstracts since 2023.
Outpatient CAR-T across a multisite network1
90%+
of CAR-T therapies delivered in the outpatient setting
Outpatient step-up dosing for bispecific T-cell engagers2
89%
of patients who began step-up dosing outpatient reached full dose
Earlier CRS recognition with continuous monitoring3
7 hrs
median earlier recognition of CRS than standard inpatient nursing care
Planning an advanced therapy trial?
We’ll help you design safety monitoring and escalation for participants outside the clinic, from the first site to the last.