Chronic heart failure, once daily oral therapy
Assessing hospitalization rates and functional capacity over an 18 month follow up.
We design, manage, and report clinical trials across six therapeutic areas. Every study is held to ICH-GCP standards and independent IRB review, and every participant is looked after by someone whose name they know.
ICH-GCP compliant Operating since 1998 One site, in New York
Sponsors come to us for the parts of a trial that are easy to get wrong: the protocol, the regulatory file, the data, and the people.
Biostatisticians and medical writers turn a study question into an endpoint set and a protocol that survives review.
Submission preparation, IRB liaison, and ongoing compliance across every jurisdiction a study touches.
Electronic data capture, validation, and query resolution that leaves a clean, analysis ready lock.
Screening that fills enrollment targets without bending eligibility, and follow up that keeps participants in.
Six areas where our investigators have run the indication before, where the equipment is already in our building, and where we have referral relationships that make realistic recruitment possible.
Heart failure, hypertension, and lipid management studies, including device adjacent protocols.
Phase II to IVInflammatory bowel disease and functional GI disorders with endoscopy supported endpoints.
Phase II to IIIMigraine, epilepsy, and early neurodegenerative studies with standardized cognitive assessment.
Phase I to IIIRheumatoid arthritis, psoriatic arthritis, and connective tissue disease programs.
Phase II to IVAsthma, COPD, and interstitial lung disease with onsite spirometry and imaging.
Phase II to IIIType 2 diabetes, obesity, and thyroid studies with long horizon retention planning.
Phase II to IVStudy sponsors are named only with their permission. Where a sponsor is confidential, we describe the program in general terms.
Assessing hospitalization rates and functional capacity over an 18 month follow up.
Endoscopic remission at week 52 as the primary endpoint, with every image scored by an independent central reviewer.
Delivered on schedule with 94% retention through the extension period and a clean database lock.
We review the study question, the realistic recruitment pool, and the regulatory path before committing to a timeline.
Protocol, statistical analysis plan, and IRB submission are prepared together so the file is internally consistent.
The site is activated, participants are consented and enrolled, and monitoring runs continuously rather than in a panic at the end.
Queries are resolved, the database is locked, and you receive an analysis ready dataset with its full audit trail.
Before anything else happens, you sit down with a clinician who checks whether the study is genuinely right for you. Basic measurements, a look at your history, and as many questions as you want to ask.
We do not run online eligibility checks. Whether a study suits you depends on your medical history, your current medication, and a conversation with a clinician, none of which a web form can judge responsibly.
Email or call us and a member of the research team will talk you through what is currently open, what taking part would involve, and what it would ask of your time.
Every study has a named principal investigator who is accountable for it from activation to close out.
Leads our heart failure and hypertension programs, with a particular focus on studies in older participants living with several conditions at once.
Runs our inflammatory arthritis portfolio and chairs the internal review that signs off every protocol before submission.
Specializes in migraine and epilepsy trials, and built the standardized cognitive assessment protocol used in every neurology study we run.
“They flagged a recruitment shortfall in month two rather than month nine, and came to the call with three options already costed. That is not the norm.”
“I was told exactly what each visit involved before I agreed to anything, and I was reminded more than once that I could stop. That is why I stayed in.”
“The database lock was the least stressful part of the program. Queries had been closed as we went, so there was nothing left hiding at the end.”
Tell us the indication, the endpoints, and the timeline you are working to. We will tell you honestly whether we are the right partner.