eCRF Software
Design, build, and deploy electronic Case Report Forms faster with QuantClinica's drag-and-drop eCRF software. CDASH-compliant templates, advanced validation, and 21 CFR Part 11 ready.
An electronic Case Report Form (eCRF) is a digital version of the paper CRF used in clinical trials to collect patient data. Unlike paper forms, eCRFs enable real-time data validation, automated queries, and immediate data availability for analysis.
QuantClinica's eCRF software provides an intuitive drag-and-drop interface that lets you build complex forms, define validation rules, and deploy them across studies without writing code.
For decades, clinical trials relied on paper Case Report Forms to capture patient data. Sites filled out forms by hand, couriered them to data management, where teams manually entered data into databases. This process introduced delays measured in weeks, transcription errors, and query cycles that slowed study timelines. Every paper CRF required physical storage, double data entry, and extensive source document verification.
Electronic Case Report Forms eliminate these bottlenecks. Data entered at the site is immediately available for review. Built-in validation rules catch errors at the point of entry, reducing query rates by up to 80%. Sponsors and CROs gain real-time visibility into data collection progress, enabling faster lock decisions and earlier database cuts for interim analysis. The shift from paper to eCRF is not just about digitization — it is about reengineering the data collection workflow for speed and accuracy.
Regulatory guidance from FDA and EMA strongly encourages electronic data capture. With 21 CFR Part 11 compliance built into modern eCRF software, organizations meet regulatory requirements for electronic records and signatures while accelerating study startup. QuantClinica's eCRF platform bridges the gap between regulatory rigor and operational efficiency, giving you the best of both worlds.
Build forms visually with an intuitive interface. Add fields, sections, and validation rules without programming.
Define range checks, logic checks, required fields, and cross-form validation rules to ensure data quality.
Standardized data collection aligned with CDASH (Clinical Data Acquisition Standards Harmonization).
Manage amendments with full version history and audit trails. No study disruption during mid-study changes.
Save form templates, field definitions, and validation rules for reuse across studies. Consistent standards every time.
Connect eCRFs with lab data, ePRO, eConsent, and external data sources through standard APIs.
Beyond basic form design, QuantClinica's eCRF software includes enterprise-grade features that accelerate study builds and enforce data integrity across every visit and assessment.
Pre-built field definitions aligned with CDASH v2.2 standards. Drop in standardized assessments for vital signs, lab results, adverse events, and concomitant medications.
Show or hide questions based on prior answers. Route participants through different form paths depending on study arm, visit number, or adverse event severity.
Create multi-arm study designs with branching logic that adapts form structure to each subject's unique data path. One form definition handles complex protocol designs.
Define computed fields that calculate BMI, eGFR, change from baseline, and derived endpoints in real time. Reduces downstream programming effort for SDTM mapping.
Electronic signatures with biometric or credential-based authentication. Full signature manifest and binding between signer, timestamp, and form data for audit readiness.
Every form change tracked with who, what, and when. Deploy mid-study amendments without disrupting active records. Roll back to previous versions when needed.
Build once, use across studies. Maintain institutional standards for adverse event tracking, medical history, and lab normal ranges. Library updates propagate consistently.
Deploy forms in multiple languages from a single design. Country-specific translations for patient-facing fields while keeping the data dictionary in a single language.
The design of an eCRF directly determines the quality of data collected during a clinical trial. Poorly designed forms generate ambiguous data, increase query rates, and delay database lock. Well-designed eCRFs with clear field labels, appropriate data types, and embedded validation rules produce cleaner data that requires less manual review. Studies using optimized eCRF designs report up to 60% fewer queries compared to paper-based or poorly digitized forms.
Fewer data entry errors with real-time validation
Reduction in query rates vs. paper CRFs
Faster database lock with validated eCRFs
Less time spent on data cleaning per study
Based on industry benchmarks from published clinical trial data management studies.
eCRF software is used to create electronic Case Report Forms for clinical trials, allowing sites to enter patient data digitally instead of on paper forms.
eCRFs enable real-time validation, automated query generation, remote monitoring, and instant data access. Paper CRFs require manual data entry and are prone to errors and delays.
CDASH (Clinical Data Acquisition Standards Harmonization) provides standardized field definitions and naming conventions for consistent data collection across studies.
Yes. QuantClinica eCRF software supports mid-study amendments with full version control and audit trails, without disrupting active data entry.
Yes. QuantClinica eCRF fields can be tagged with SDTM domain and variable mappings during the design phase, reducing downstream programming effort for study data tabulation.
Yes. The platform supports multi-language form labels and instructional text from a single form definition, enabling consistent data collection across countries and languages.
Skip logic is configured through a visual rule builder. You define conditions based on field values, and the eCRF engine automatically shows, hides, or disables subsequent fields without requiring custom JavaScript or programming.
Existing data is preserved against the original form version. The new form version applies only to newly entered or unsaved records, ensuring data integrity and full audit trail compliance during mid-study amendments.