Why DVCR?
Built differently for FIH studies
The foresight to help avoid FIH delays
Operational challenges such as eligibility criteria revisions or misaligned PK analysis timelines can often be identified before they affect study progress. At DVCR, these risks are addressed during study planning to support efficient dose escalation and more predictable study execution.
Purpose-built infrastructure for FIH execution
Our Phase I unit is designed to support the intensive safety monitoring requirements of FIH studies. The unit features wall-mounted vital sign monitoring systems at each bedside, strategically located crash carts, continuous video surveillance throughout volunteer areas and multiple nearby hospitals.
Early collaboration for optimized study design
Early alignment on protocol design, recruitment feasibility, regulatory considerations and investigational product requirements can prevent delays later in the study lifecycle. Our team engages proactively before IND submission to help identify and address potential challenges, supporting a more efficient startup process and smoother study execution.
Structured dose escalation governance
Dose escalation decisions require clear oversight and consistent processes. DVCR can support studies with a dedicated Dose Escalation Committee (DEC), predefined escalation criteria and structured cohort reviews to enable timely, data-driven decisions throughout study execution.
Sentinel dosing as standard practice
For first-in-class and large molecule studies, we establish sentinel dosing protocols as a matter of course, including adequate subject screening to ensure the sentinel and remainder cohorts are dosed on schedule, limiting delays.
Sponsor visibility built into the model
Integrated eSource and EDC systems give sponsors direct and real-time access to safety data including vital signs, ECGs, safety labs and other data throughout the study — the same data the DEC relies on for each escalation decision. Communication is proactive and continuous, so sponsors always know where their study stands.
Our approach to FIH studies
We engage before protocol finalization to minimize amendments later. Where the data supports it, adaptive design options are explored during protocol review, allowing sponsors to incorporate flexibility early and strengthen the study design from the study start.
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Kickoff and protocol input
- Inclusion/exclusion criteria reviewed with site medical team prior to finalization
- Sentinel dosing language confirmed in protocol and informed consent
- Dose escalation timelines structured to account for PK sample shipment, processing and analysis
- Study blinding requirements are carefully considered when planning and delivering pre-lock data, whether sharing raw data or blinded summaries to the DEC
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Dose escalation governance
- Dose Escalation Committee (DEC) established at study start with a defined escalation charter
- Safety data, adverse events and available PK data reviewed formally between each cohort
- DEC decision communicated to IRB before advancing to the next dose level
- PI and medical monitor directly accessible and consistent from startup to closeout
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Cardiac safety integration
- Early Precision QT (EPQT) available for direct integration into study design
- DVCR leverages partnership with industry leading SMEs to ensure study design allows for concentration-effect modeling and high-precision ECG analysis across dose groups
- Can satisfy QT regulatory requirements without a standalone TQT study
FIH infrastructure
Phase I unit
- 100 beds for overnight confinement
- Wall-mounted vital sign machines at each bedside
- Integrated with eSource/EDC for automatic and real-time data upload, reducing transcription errors
- Strategically placed crash carts and video surveillance in volunteer areas for enhanced subject safety
- Multiple nearby hospitals
Pharmacy
- On-site cGMP pharmacy with 50+ years of combined staff experience
- Experienced in preparing study drugs across various routes of administration, adhering to blinding requirements as necessary
- Capable of handling study drugs from Schedule I-V
- For IV biologics: sources DEHP-free bags, in-line filters and infusion pumps through approved vendors prior to study start
Volunteer screening
- Extensive volunteer database integrated with eSource
- Rigorous pre-screening process streamlines qualification for screening
- Use of Verified Clinical Trials (VCT) biometric screening to prevent dual enrollment
Featured study
Challenge
A first-in-human study required rapid pharmacokinetic data review to support critical dose-escalation decisions while maintaining participant safety. Timely access to high-quality PK data was essential to evaluate exposure levels and guide decisions as the study progressed.
Approach
DVCR implemented a comprehensive PK strategy that included careful scheduling of dosing activities, expedited sample processing and close coordination with bioanalytical partners. The team delivered rapid PK analyses and blinded data summaries, enabling ongoing evaluation of exposure levels while maintaining study integrity.
Outcome
The accelerated turnaround of PK data enabled informed dose-escalation decisions and supported participant safety throughout study conduct. By providing timely, high-quality data and scientific expertise, DVCR helped the sponsor efficiently advance the study while maintaining rigorous operational and clinical standards.
Related resources
Planning a FIH study?
Talk to a team with extensive FIH expertise.
Whether you are planning a first-in-human study, a SAD/MAD program or a more complex early phase trial, we will discuss your objectives, key study considerations and the capabilities that support predictable execution from first dose through CSR.
