EDC for pre-clinical to clinical transition: first-in-human readiness, safety and PK capture, and 21 CFR Part 11–aligned controls in one platform.
21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required
First-in-human studies generate more data per participant per day than almost any other study type. A typical SAD cohort day may involve pre-dose assessments, dose administration with exact timestamp, and 10–15 post-dose PK blood draws at precise time points (e.g., 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose), along with vital signs, ECGs, and safety labs at multiple intervals. This density of data collection requires an EDC system that can handle time-stamped entries, complex visit structures, and rapid data entry without slowing down the clinical site. Capture supports these workflows through configurable visit schedules with time-point-specific forms. Each PK sample collection can be logged with an exact datetime, and edit checks can flag samples collected outside protocol-defined windows. Safety assessments (vital signs, labs, ECGs) are captured alongside PK data in the same visit structure, giving the medical monitor a complete picture of each participant’s status at every time point. This integrated view is critical during dose-escalation decisions, where the safety and PK profile of the current cohort determines whether the next dose level proceeds.
FIH protocols are inherently adaptive. Dose-escalation decisions depend on emerging safety and PK data. New cohorts may be added (e.g., food-effect, Japanese bridging, or additional dose levels). Sampling schedules may be refined based on preliminary PK results. Inclusion or exclusion criteria may be tightened based on early safety signals. These changes need to be reflected in the EDC system quickly and cleanly, without disrupting data already collected for earlier cohorts. Capture handles protocol evolution through its configuration-driven amendment process. Study builders can add new dose cohorts, modify visit schedules, update CRF forms, and revise edit checks through the browser. Each amendment is documented in the audit trail with version information, timestamps, and reason-for-change. Data collected under earlier protocol versions is preserved with its original version context, so the complete study history is traceable during analysis and regulatory review. This self-service amendment capability is particularly important for FIH studies, where dose-escalation meetings may result in study changes that need to be implemented within days. Waiting weeks for a vendor to process form changes is not compatible with the pace of FIH development.
The pre-clinical to clinical transition represents your first significant investment in clinical trial infrastructure. The EDC system you select, the CRF designs you build, the consent workflows you establish, and the data export structures you develop all have implications beyond your FIH study. If your FIH produces positive safety and PK data, you will likely advance quickly to a Phase 1b or Phase 2 study—and the speed and efficiency of that transition depends in part on the technology decisions you made at the FIH stage. Capture is designed to carry your investment forward. The CRF library you built for your FIH study—demographics, medical history, safety panels, PK collection forms, conmed logs—can be cloned and adapted for your next protocol. Sites and CRUs trained on Capture need minimal re-onboarding. Your data team retains familiarity with export structures and analysis pipelines. And your regulatory team can reference validation documentation from the FIH study when qualifying the system for subsequent protocols. This technology continuity across study phases is a meaningful operational advantage, particularly for startup and early-stage biotech companies where every week saved in study transition directly impacts burn rate, timeline to key milestones, and investor confidence in your ability to execute.
Overview
The pre-clinical to clinical transition is one of the most critical inflection points in drug development. Your compound has completed IND-enabling non-clinical studies—toxicology, pharmacology, ADME, manufacturing—and the regulatory authority has cleared (or is reviewing) your IND or CTA. Now you need to move from laboratory science to human subjects research, and the operational requirements change fundamentally. You need an electronic data capture system that can support first-in-human (FIH) readiness: protocol-driven visit schedules, informed consent capture, dense safety and pharmacokinetic sampling workflows, adverse event reporting, and a complete audit trail that meets regulatory expectations from day one. This transition is time-sensitive. Every week of delay between regulatory clearance and first dose costs money and extends your timeline to proof-of-concept data. Yet this is also the stage where many teams first encounter the clinical trial software market and discover that enterprise EDC platforms require months of implementation, large upfront commitments, and feature sets designed for programs far larger than their Phase 1 study. Capture provides EDC, eConsent, ePRO, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure. The platform is designed for exactly this moment: when you need to go from protocol finalization to data capture readiness as quickly as possible, without compromising on compliance or audit trail integrity. Study builders configure CRFs, visit schedules (including dense PK sampling windows), consent forms, and edit checks through the browser. The same system handles informed consent, clinician-entered CRF data, safety reporting, and optional patient-reported outcomes. For teams making this transition for the first time, Capture provides a structured path from protocol to production: build in a free sandbox, test with your study team, validate when required, and deploy to production. For experienced teams, the configuration-driven approach means you can have your study ready for first dose in weeks rather than months.
The pre-clinical to clinical transition places unique demands on your data capture infrastructure. Unlike ongoing clinical programs where teams have established EDC systems and operational playbooks, this transition often represents the first time a team needs to select, implement, and deploy clinical trial software. The learning curve is steep, the timeline is compressed, and the stakes are high. FIH protocols are typically safety-focused with dense sampling schedules. A single-ascending-dose (SAD) or multiple-ascending-dose (MAD) study may require 15–20 blood draws per participant per day during dosing periods, each captured with exact timestamps. Sentinel dosing rules may require that only one or two participants receive the compound before safety data is reviewed for the remaining cohort. These operational patterns require an EDC system that can support complex visit structures, time-stamped sample collection, and flexible cohort management. At the same time, the protocol is likely to evolve. Pre-clinical data may inform dose adjustments, cohort additions, or changes to the sampling schedule after the study has started. Your EDC must handle these amendments cleanly, with version control and audit trail documentation that demonstrates exactly what changed, when, and why. Capture is built for this transition: one platform that is fast to deploy, easy to amend, and maintains the audit trails and access controls suitable for regulatory and ethics review. You do not need global Phase 3 features—you need one system that gets you from IND clearance to first dose without delay and captures the safety and PK data that will inform your next development decision.
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