Services
Expert Services for Early Phase Clinical Trials
At DELPHINIUM, we are a boutique CRO dedicated to early phase clinical trials. Our core business is helping sponsors navigate the complexities of First-in-Human (FIH) and exploratory studies; where new medicines are first introduced to patients or healthy volunteers.
But what truly sets us apart is the way we deliver these studies: through a tightly integrated suite of services, each tailored specifically for early phase research. Every part of your study, from protocol design to clinical execution and data delivery, is handled by experts focused exclusively on this critical phase of drug development.
Comprehensive Services for Early Phase Success
We offer a complete, end-to-end service portfolio for sponsors running early phase trials, including:
- Clinical Project Management
Full oversight of your trial: startup, execution, monitoring, and closeout, led by a senior project manager experienced in phase I clinical studies. - Pharmacy Services
Secure management of investigational drugs, including storage, compounding, blinding, and preparation for dosing — all under strict compliance standards. - e-Source & Digital Data Capture
Modern, audit-ready systems for collecting accurate clinical data in real time, ensuring data integrity and fast turnaround. - Hospital Collaborations
Access to inpatient and outpatient units through our established hospital partnerships, ensuring flexibility and continuity in volunteer care and study execution. - Regulatory & Operational Support
From feasibility and ethics submissions to medical writing, safety documentation, and beyond. We streamline the entire operational landscape of your early phase study. - Other services
We work with trusted, qualified partners to provide data management, medical writing, bioanalytical services, clinical monitoring, statistics, and pharmacovigilance for your next clinical trial.
To explore how our early phase services can support your next trial, contact our team.
Our Core Expertise in Phase I Clinical Trials
Every service we offer is designed to support the rigorous demands of early phase clinical research. We are experienced in conducting:
- First-in-Human (FIH) studies
- SAD/MAD (Single and Multiple Ascending Dose)
- Drug-Drug Interaction (DDI)
- Food Effect Studies (FDA-standardized meals)
- Pharmacokinetics/Pharmacodynamics (PK/PD)
- Bioavailability & Bioequivalence (BA/BE)
- Thorough QT/QTc studies
These trials help determine drug safety, tolerability, maximum tolerated dose, and initial efficacy indicators — all under close clinical monitoring.
“Working together with Dr. C. Voors-Pette and her team on our Phase I First-in-Human study was a pleasure from beginning to end. We collaborated thoughtfully and efficiently on the study protocol, and every challenge was handled proactively. The data quality was excellent.” ~ A. Frostegård, Chief Scientific and Medical Officer, Annexin Pharmaceuticals
Built on Experience and True Collaboration
With over 80 years of combined experience and 50+ successful clinical trials, our team provides expert guidance from the first draft of your protocol to the final study report. We work closely with sponsors, providing clear communication, proactive planning, and a true partnership mindset.
“Working with the colleagues who are now at DELPHINIUM was like working with a CRO that was truly a part of the sponsor team. We felt confident in the safety of our subjects and the project management of the clinical trial in their hands.”~ VP of Clinical Development Operations of multiple biotechs in Cambridge, MA.
Ready for some strategic insights from the team?
