Clinical Trials AI
M

Massive Bio

Oncology clinical trial matching and enrollment company based in Boca Raton, Florida. Its SYNERGY-AI platform extracts clinical and biomarker details from patient records and matches patients against more than 19,000 active oncology and hematology trials, with oncology nurses and patient relations coordinators reviewing matches and guiding patients through enrollment; Reticulum Nexus, launched in January 2026, coordinates the work through language model agents.

Patients use it free through Patient Connect and the Ask Fiona AI assistant, physicians through Trial Relay and Dr. Arturo AI, and drug makers buy recruitment reporting and commercial analytics (Trial Vision, the Drug Utilization Optimizer, NexusPulse). A company-led prospective study of 3,804 patients, published in 2026, reports F1 0.82 for eligibility matching and screening time cut from about 120 to 30 minutes per patient. The company reports more than 200,000 onboarded patients across 18 countries.

AI Health Index verifiedSeptember 29, 2026
Compare Massive Bio with other vendors
Founded
2015
Headquarters
Boca Raton, Florida
Website
massivebio.com
Categories
clinical-trials-ai
Indexed Products
SYNERGY-AI, Reticulum Nexus, TrialRelay, Patient Connect, NexusPulse
Buyer Segments
Pharma / Life Sciences, Medical Group, Community Health System
Assessment

Capability Axes

An AI Health Index grade measures what a buyer can verify from public sources on the date shown. It is not a rating of how good the product is. A vendor can build an excellent system and grade low on an axis because it publishes nothing an outsider can check. How grades read

AI Capability
BB on AI CentralityThe model is the engine of a core module. The platform carries other value, but this capability does not exist without it.
Vendor Published

The matching models are the engine of the core service, and the company sells more around them. The solutions page describes language understanding that extracts more than 500 clinical parameters from records, trial and drug matching models, a de-identification model and two large language model assistants (Dr. Arturo AI for physicians, Ask Fiona AI for patients), coordinated since January 2026 by Reticulum Nexus, which the company describes as more than 100 agents.

Around that engine it sells work done by people and data products: patient relations coordinators and oncology nurses who review matches and guide enrollment, concierge logistics, recruitment reporting for sponsors (Trial Vision), and commercial analytics for drug makers (the Drug Utilization Optimizer and NexusPulse). The concierge and navigation service carries value without the models; matching at the stated scale does not exist without them.

BB on Autonomy and Oversight ModelThe oversight structure is described and one part is missing, commonly the threshold at which the system stops or what happens after it is wrong.
Vendor Published

Review is built into the matching workflow, and the newer autonomy claims come with no limits. In the company's published study, extraction and matching agents produced candidates that clinicians verified against linked record passages, ambiguous timing was routed to clinician judgment, an undocumented mandatory criterion was treated as not met, and matches reached an oncologist-validated list; the service pages say oncology nurses review matching reports and that final eligibility rests with the investigator.

Two things fall outside that structure. Patients who upload records are told they will see preliminary matches instantly, ahead of the tailored report within 24 hours, and the patient assistant, Ask Fiona AI, answers patients directly. And Reticulum Nexus was announced in January 2026 as a fully autonomous operating system whose agents coordinate next-best actions across patients, sites and sponsors. What the preliminary matches, the assistants and the autonomous agents may not do, and what stops them, is not published.

BB on Model and Technology TransparencyThe approach or the suppliers are named without the version and update discipline behind them. Naming a supplier is the entry to this band both here and on Model Supply Chain Disclosure, which ask different questions of the same disclosure: who receives the data, and what produces the output.
Peer Reviewed Publication

The architecture is named in detail; a buyer cannot tell when it changes. The company's 2026 study describes OncoAgents (domain-tuned language model agents for extraction, normalization and matching), OncoGraph (an oncology knowledge graph that applies inclusion, exclusion and timing rules deterministically, with version-controlled updates), OncoRecommend (prioritization) and OncoSet (more than 2,000 annotated records, 14,000 trials and 50 tumor subtypes used to train and calibrate the agents).

The solutions page adds language understanding for records, a de-identification model and large language model assistants. The base models under the agents are not named in the study; company research compares GPT-4.1 with GPT-4.0 for report extraction and describes a GPT-4o platform for cell therapy matching, and the company has announced OpenAI work on protocol parameterization and pre-screening. No release history or update notice is published.

BB on Model Supply Chain DisclosureSubstantial partial disclosure, or a chain that is structurally short: an in house build, a cleared model that cannot be quietly swapped, or a deployment where the transfer does not occur at all. Naming the model provider exits the band below into this one; the axis rises from here on the completeness of the party list and on the terms that govern data once it arrives.
Vendor Published

The model provider is named and most other parties are listed by type. The company announced in August 2026 that it is an OpenAI Select Partner, building on earlier OpenAI work for protocol parameterization and real-time patient pre-screening, and a 2023 partnership brings Datavant's record retrieval into its operations.

The patient authorization lists recipients by type: laboratories and genomic testing facilities, contract research organizations, pharmaceutical and diagnostic companies, real world data partners and trial sites. What reaches OpenAI and under what retention and training terms, the cloud host, and a named subprocessor list are not published.

AA on Clinical and Operational EvidencePeer reviewed or independently evaluated performance, prospective and multi site where the claim requires it, with the method available to read. The grade describes the strength of the evidence, not its direction: a rigorous study that found no benefit grades by its design, and the note leads with what it found.
Peer Reviewed Publication

A prospective, peer reviewed evaluation of the product with its method open to read, run by the company. Loaiza-Bonilla and colleagues (ESMO Real World Data and Digital Oncology, 2026, open access; five of seven authors company founders or staff) screened 3,804 consecutive patients with metastatic or progressive solid tumors at US academic and community sites from January to December 2024: 157,367 record pages and 23,912 patient and trial pairs, against a gold standard from two oncologists.

The system reached F1 0.82 against 0.47 for GPT-4 zero-shot and 0.67 for GPT-4 chain of thought; screening time fell from a median 120 minutes to about 30 (15 automated, 15 clinical review), and median time to an oncologist-validated list was under 7 days. Ablations credit the knowledge graph and the split into agents.

The authors state the limits: identification only, with no consent, enrollment or completion outcomes; the sites are not named; and they call for external validation across record vendors, sites and populations before broad deployment. Hematologic cancers and the non-US markets the company serves were not in the cohort. Scale figures on the site (200,000 onboarded patients, more than 19,000 trials) describe use, not benefit.

BB on AI Safety and PHI StewardshipCategorical commitments are published, such as no training on customer data, without the retention schedule behind them.
Vendor Published

Retention and training use are stated; the de-identification method is not. The patient authorization (last updated 11/10/2025) covers complete medical records including genomic results, mental health treatment, substance use disorder treatment, HIV status and sexually transmitted diseases, with psychotherapy notes only on separate authorization, and states that anonymized and aggregated data created by the company may be used for analytics, AI training and real world evidence research.

The privacy policy (last updated 04/06/2026) keeps patient profile data for ten years after collection or last activity and de-identified or aggregated data without a fixed term; the authorization runs ten years unless revoked, and revocation stops new processing of identifiable data within 30 days without reaching what was already used. No de-identification method is named, which matters for genomic data. Two uses need a direct answer.

The Drug Utilization Optimizer is described as integrating consented patient data with physician profiles to give drug makers' commercial teams real-time notifications of cases, and NexusPulse turns consented clinical and biomarker data into signals for commercial and market access teams; the authorization's stated purposes are eligibility, diagnostic and therapeutic analysis, and the privacy policy says customer information is not sold. Nothing is published on safety engineering for the language model assistants: guardrails, hallucination handling or how a safety event is handled.

Regulatory and Compliance
BB on HIPAA and BAA PostureBusiness associate status is stated and supported by a substantive privacy document, with the agreement or its scope not fully published. For a vendor outside the United States, an equivalent regime documented to this depth grades here. A vendor whose product does not process protected health information grades here too when it says so plainly and explains the scope, with a service privacy document behind it: stating a position a buyer can rely on is the posture this axis grades, and the band above is closed to it because there is no agreement to publish.
Vendor Published

Business associate status is stated and a substantive patient document stands behind it; no agreement is published. The patient authorization (last updated 11/10/2025) says the company and its subcontractors operate as business associates bound by business associate agreements, and sets out the records covered, purposes, recipients by type, revocation and access rights, with a named data protection officer.

The privacy policy says the company is not a covered entity, and the company's study ran at health networks under a business associate agreement. Records gathered on a patient's own authorization, as the patient's agent, travel a different path from records a provider shares under an agreement, and the documents do not say which protections follow each.

BB on Security Certifications and Trust CenterA recognized certification is named in the vendor own material without the artifact, or with a scope or renewal question the buyer has to raise. A recognized certification here is an audit of how the vendor operates security, such as SOC 2, HITRUST or ISO/IEC 27001. A certification has a scope and a clock, and both are part of this grade. A certification the vendor attaches to its data center, hosting facility or cloud provider, rather than presenting as its own, is the host's and does not count here.
Vendor Published

A recognized attestation is named without the report. The terms say the company maintains SOC 2 certification, the privacy policy says it maintains SOC 2 controls, and the home page carries an AICPA SOC badge. The type, period and scope are not stated and there is no trust center. The privacy policy describes encryption in transit and at rest, access controls, pseudonymization, VPN and firewalls. The data held is sensitive: full records including genomic and mental health information for a reported 200,000 onboarded patients.

CC on FDA and Regulatory StatusNo device claim is made and the product is scoped accordingly. Most administrative and operational products sit here and are not penalized for it, because this axis grades the appropriateness of the positioning rather than possession of a clearance.
Vendor Published

No device claim is made, and trial matching is scoped as information. The company says it does not practice medicine, its reports are for educational and informational purposes, treatment decisions rest with the treating physician, and trial participation is decided by the sponsor or investigator.

No regulatory position is stated for the clinical functions offered beside matching: the solutions page lists drug matching among its AI tools, the patient authorization covers analysis of diagnostic options and therapeutic optimization, and Dr. Arturo AI summarizes a patient's disease for physicians.

BB on AI Governance and Bias DisclosureA governance framework with named process behind it, such as certification to an artificial intelligence management standard, or material written for a customer own review committee to evaluate the product with. A framework covering the vendor whole portfolio counts when its scope reaches this product; what it cannot supply is the product specific evaluation the band above asks for. Published results within the one group where the performance of this product is most at risk also sit here: evaluation on the question this axis asks, short of the comparison across groups the band above requires. A medical device clearance or certification, and the quality system behind it, does not reach this band on its own; it is graded under regulatory status. A regulator reviewed plan governing how the model may change does reach it.
Peer Reviewed Publication

A subgroup evaluation is published with its groups and one gap, and the per group figures sit in a supplement. The company's prospective study (Loaiza-Bonilla and colleagues, ESMO Real World Data and Digital Oncology, 2026; first and corresponding author the company's co-founder and chief medical and AI officer, five of seven authors company founders or staff; announced by the company in April 2026) compared sensitivity, specificity, precision and F1 across age, sex, race and ethnicity against a pre-specified alert at a 10 point F1 gap.

The text reports that no group crossed it and that the largest difference was about 7 points, with Black patients below white patients, which the authors attribute mainly to fragmented care histories and missing staging. Group sizes and intervals are in Supplementary Table S5, outside the open article text. The figure of F1 by race is captioned illustrative, and its bars (white near 0.87, Black near 0.75) sit further apart than the 7 points in the text. Two questions stay open.

Patients with thin records are less matchable regardless of eligibility, and the study measures accuracy among patients who reached the service, not who never did. And sponsors fund part of the service: the patient authorization discloses that trial sponsors may pay the company for concierge and navigation once a trial is chosen, and nothing states whether sponsor relationships affect which trials are shown or in what order.

BB on AI Liability and RecourseA published falsifiable commitment, or a real correction route the affected person can exercise against the vendor. A published error rate with its method and denominator grades here. A statutory right that runs to the covered entity rather than to the vendor does not reach this band on its own: every other route here asks something of the vendor, and being located in a particular jurisdiction is not conduct.
Peer Reviewed Publication

A published error rate with its method and denominator, adopted by the company, and nothing behind it beyond that. The prospective study the company announced in April 2026 (Loaiza-Bonilla and colleagues, ESMO Real World Data and Digital Oncology, 2026; 3,804 consecutive patients with metastatic or progressive solid tumors at US academic and community sites during 2024) reports sensitivity and specificity of about 0.84, precision 0.81 and F1 0.82 (95 percent interval 0.81 to 0.83) over 23,912 patient and trial pairs, against eligibility labels from two oncologists who agreed at kappa 0.92.

Pairs with ambiguous timing were routed to clinician judgment and left out of the F1, so the rate describes the pairs the system could decide. At a sensitivity near 0.84, about one eligible pair in six was missed. This is a study result on the version tested, not performance in use. The patient authorization says reports are informational, the company is not liable for clinical outcomes, and enrollment is decided by sponsors and investigators; the terms exclude damages. Patients can request access, amendment or restriction of their records by email.

Integration and Deployment
BB on EHR and Interoperability DepthNamed systems with read access or one directional writing, or standards support with named deployments behind it.
Vendor Published

Records reach the company three ways, one of them through a named network. Patients and physicians upload records in any format; the patient authorization invokes the right of access, under which providers must release records within 30 days to the patient's authorized agent; and a partnership announced in June 2023 brings Datavant's medical record retrieval (Switchboard) into the company's operations.

The company's study describes health network deployments running on the network's own record data, with an oncologist-validated list returned to the record, and names no record system. NexusPulse structures data to the mCODE model. No named record system connection, marketplace listing or FHIR interface is published.

CC on Deployment Model and Data ResidencyA single hosted option with location implied rather than committed.
Vendor Published

A hosted service with location implied rather than committed. The privacy policy says personal information may be stored and processed in the patient's region or another country where the company and its service providers keep servers, and uses standard contractual clauses for transfers from the EU and EEA to the United States.

The company's study describes a different option for health networks: the system ran in the networks' own environment, on premises or in a role-controlled virtual private cloud, with agent messages kept there. The hosting regions, the cloud provider, tenant isolation and where patient-uploaded records rest are not stated.

Commercial
CC on Commercial TransparencyNo price is published and the posture is discoverable: a buyer can establish how the product is sold and what drives the cost before contacting the vendor. Most of the index sits here.
Vendor Published

No price is published, and how the business is paid is discoverable. The service is free to patients and caregivers; revenue comes from pharmaceutical, contract research and provider contracts, and the patient authorization discloses that a trial sponsor may pay the company for concierge, navigation and last-mile coordination once a patient pursues a specific trial. Products for drug makers (Trial Vision, the Drug Utilization Optimizer, NexusPulse) carry no published terms.

BB on Setting and Specialty CoverageCoverage is named with validation behind part of it.
Vendor Published

Coverage is named and validated for part of it. The service covers oncology and hematology trials, including pediatric trials, for patients and physicians in 18 countries and 11 languages, searching more than 19,000 active trials.

The company's prospective study validates matching for patients with metastatic or progressive solid tumors at US academic and community sites; hematologic cancers and non-US records were not in it, pediatric patients are not reported, and the authors give extraction fidelity above 95 percent on internal records and about 89 percent on external scanned referrals.

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Ordered by how closely the graded profiles match across the fifteen axes, inside the same categories. See how each axis is graded in the methodology.

Comparisons

Compared With

Each comparison carries a written verdict, the buyer conditions that favor each vendor, and a graded side by side. Pairs that cross a category boundary are grouped separately, and their verdicts state where the boundary sits rather than manufacturing a head to head.

Commercial

Pricing

Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.

Entry Price Pricing Basis BAA Tier Implementation Source
Contact the vendor
Pharma, CRO, and provider contracts; patient facing application is free to patients Business associate status stated in the patient authorization; no agreement published. — Vendor Published

No price is published. The service is free to patients and caregivers. Revenue comes from pharmaceutical, contract research and provider contracts, and the patient authorization discloses that a trial sponsor may pay the company for concierge, navigation and last-mile coordination once a patient pursues a specific trial. Products for drug makers (Trial Vision, the Drug Utilization Optimizer, NexusPulse) carry no published terms.