Your next study population may already be in our care

Clinical Research for Sponsors and CROs

Istios Health gives sponsors and CROs access to an integrated network of specialty practices, patients already characterized by clinical phenotype, and the physicians who care for them. We combine longitudinal clinical data with coordinated research operations to support faster study startup and enrollment grounded in identifiable patient populations.

Our nephrology, gastroenterology and infectious disease sites bring clinical depth to research involving Cardiovascular-kidney-metabolic (CKM) syndrome, as well as liver disease and infectious disease. These CKM patient populations also support broader cardiovascular, renal and metabolic (CVRM) drug-development programs. Trials are embedded in practices where patients have established relationships with their physicians.

Supporting study execution

Feasibility grounded in patients already under care

Our integrated database and physician relationships help us assess whether a study’s target population is present within the network. We use existing clinical phenotypes to identify potentially relevant cohorts, then work with investigators to evaluate protocol fit and the practical requirements of enrollment.

This gives sponsors a more informed starting point for site selection and recruitment planning, including which criteria need additional chart review or screening.

Coordinated startup across participating sites

Istios coordinates study operations, research staffing, regulatory activities and sponsor communication across the network. Shared processes help participating practices prepare for activation and address study requirements consistently, with investigators retaining responsibility for clinical decisions and participant safety.

Enrollment through established physician relationships

Potential participants are identified within practices already involved in their care. Physicians and research teams can introduce appropriate studies with the context of each patient’s diagnosis, treatment history and care needs. This supports focused outreach and gives patients a familiar setting in which to consider participation.

Continuity throughout the study

Embedded research teams coordinate study participation alongside ongoing specialty care. Established relationships and longitudinal clinical follow-up provide a foundation for participant engagement, visit coordination and the collection of clinically meaningful data.

A practical route from protocol to enrollment

We assess the target phenotype against available clinical data, review potential cohorts with investigators, and evaluate site requirements. Participating sites then complete startup and prepare outreach under the applicable approvals. Patient consent and protocol-specific screening determine who can enroll.

Research across connected kidney and metabolic conditions

CVRM studies often require patients with a specific combination of kidney function, albuminuria, blood pressure, metabolic risk and background therapy. Our practice-based model connects sponsors with the specialists who routinely evaluate these factors and follow how they change over time.

Nephrology

Our nephrology practices provide access to patients with chronic kidney disease, diabetic kidney disease, hypertension and overlapping cardiovascular and metabolic risk. Ongoing clinical care provides the history needed to evaluate disease progression, treatment exposure and potential study fit.

For sponsors, this creates a practical foundation for identifying cohorts defined by renal function, albuminuria, diabetes status, blood pressure and current therapy, subject to available data and protocol review.

Gastroenterology

Our gastroenterology practices extend the network’s reach into digestive and liver disease, including patients whose metabolic risk overlaps with kidney and cardiovascular conditions. Connecting GI expertise with nephrology and clinical data supports the evaluation of populations relevant to programs spanning multiple organ systems.

Infectious disease

Our infectious disease practices contribute established patient relationships and expertise in the care of acute and chronic infections. The network supports infectious disease research while creating opportunities to evaluate selected populations with overlapping cardiovascular and metabolic risk, when the protocol permits.

Why the combination matters

A study may need more than a diagnosis. It may need patients with a defined combination of disease severity, comorbidities and treatment history. Istios brings specialty practices and clinical data together so sponsors can evaluate those characteristics within a coordinated network and connect with the investigators best suited to the protocol.

CKM research is a central area of focus, alongside specialty-specific kidney, gastrointestinal and infectious disease research. We evaluate each program against the clinical populations, investigator expertise and operational capabilities of the participating sites.

Identify the patient phenotype before recruitment begins

Istios Navigator

Istios Navigator connects clinical data across participating practices to help identify and characterize patient populations already receiving care. Existing phenotyping gives our research team a starting point for matching a study’s target population with the patients and investigators in our network.

For sponsors, this supports more informed feasibility, focused patient identification and recruitment planning tied to actual clinical populations.

Clinical context that informs study fit

A diagnosis alone rarely establishes trial eligibility. Relevant clinical information can include disease severity, laboratory trends, comorbidities and current or prior treatment. We use available longitudinal data and investigator review to assess those characteristics and identify where additional information is needed.

CKM population assessment

For CKM studies, the assessment may consider kidney function, albuminuria, blood pressure, diabetes status, body weight and background therapy. The criteria evaluated depend on the protocol and the data available at each participating site.

From population identification to investigator review

Navigator supports cohort identification. Our physicians and research teams then assess the clinical context, confirm relevant records and determine the next steps for approved outreach and screening. Final eligibility is established through the study’s required assessments and investigator review.

Longitudinal data for research questions beyond a single trial

The network also provides a foundation for observational research and real-world evidence generation. Longitudinal clinical information can support studies of disease progression, treatment patterns and outcomes, with each project defined by its research question, available data and appropriate permissions.

Discuss your study with Istios

Share your study indication and key eligibility criteria. Our team will discuss population fit, participating sites and study requirements.