First-in-human study execution built for certainty
DVCR supports First-in-Human studies with experienced investigators, safety-focused Phase I infrastructure, real-time data visibility and integrated early phase CRO services.
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Designed for the first step into human clinical development
FIH studies require disciplined planning, careful safety monitoring, clear escalation processes and reliable data at each decision point. DVCR helps sponsors move into human clinical development with experienced study teams, controlled Phase I conduct and integrated systems designed to support safety review and early decision-making.
FIH study experience
More than two decades of experience conducting First-in-Human studies across small molecules, large molecules, vaccines, therapeutic areas and routes of administration.
Investigator oversight
An investigator team with participation in over 50 FIH trials supports safety monitoring, cohort review and early clinical decision-making.
Dose escalation support
Real-time eSource/EDC access helps sponsors and study teams review emerging safety, PK and operational data for planned escalation decisions.
Safety-focused infrastructure
Crash carts, video surveillance, bedside vital signs equipment and nearby hospitals support participant safety during early dosing.
Controlled Phase I conduct
100-beds for overnight confinement, Verified Clinical Trials screening and an on-site cGMP pharmacy support controlled execution and reduce operational risk.
Technology-enabled data quality
Integrated systems and automated data upload support cleaner data, greater visibility and audit-ready documentation.
Built to support safety review between cohorts
FIH studies depend on timely access to safety and PK data before escalation decisions. DVCR’s Phase I environment and integrated data systems are designed to support cohort-level review, sponsor visibility and structured decision-making throughout the escalation process.
Key capabilities include:
- Real-time data access for sponsor review
- Bedside vital signs equipment to reduce variability
- Automated upload into eSource/EDC
- Standardized subject-level data collection
- PI and medical monitor involvement in escalation decisions
- Documented dose escalation outcomes for IRB submission when required
