September 17, 2025
Decoding FDA’s Recent Advertising Enforcement Actions
Key takeaways from FDA’s latest enforcement letters which mark a major shift in advertising oversight and highlight new compliance risks for Sponsors.
Role of EDC Systems
During clinical trials, data quality and study efficiency are of the utmost importance. Electronic Data Capture (EDC) software helps sponsors collect trial data and manage processes including patient form design, medical coding, and source data verification. Prior to EDC, clinical trial data was documented on 3- part NCR paper, which was liable to various pain points. Data captured incorrectly at the source, forms delayed in transit, and inefficiency in back-and-forth communication were just a few challenges that sponsors faced. Nowadays, life sciences organizations typically capture data electronically at the source (“e-source”) or transcribe paper forms into an EDC system.
EDC Operational Models
Sponsors often consider whether to take an EDC in-house or partner with a CRO. While this decision depends on the unique Sponsor and study, here are general benefits of each operational model.
In-House EDC System
- Customization: Sponsors directly decide the EDC system setup and functionality; in turn, they are responsible for validation and maintenance
- Data Autonomy: because the Sponsor owns the system, access and control of data abides by your organization’s standards and your organization only
- Speed: In-house EDCs eliminate external communication bottlenecks; once trained, Sponsor personnel may pull study information and analyze without needing to consult outside parties
Outsourced EDC System
- Expertise: CROs have established experience, infrastructure, and resources to run efficient studies, allowing Sponsors to focus on more critical aspects of clinical operations
- Cost Efficiency: CROs offer competitive pricing through fixed contracts (however, post-production changes to the protocol can quickly result in change orders and cost escalation)
- Agility: CROs can quickly deploy EDC systems across multiple studies. ProPharma can work in a variety of systems depending on your study’s phase and therapeutic area
EDC User Roles
Sponsors, contract research organizations (CRO), and sites play critical roles in clinical data collection. Common EDC roles include:
- Study Builders
- System Administrators
- Data Managers
- Clinical Research Coordinates
- Clinical Research Administrations
- Study Investigators
- Medical Coding
- Inventory Control
- Biostatistics
A robust EDC platform supports them in the following day-to-day tasks
Sponsor/CRO
- Designing customized study forms (eCRF)
- Performing Validation and/or User Acceptance Testing, both at the system and study level
- Training sites on using the EDC for each specific study
- Overseeing studies to ensure compliance with protocols, Good Clinical Practices, and all applicable regulations
- Monitoring data collection for discrepancies
- Reviewing source documentation and case report forms
- Analyzing data metrics as requested by Sponsor
- Submitting queries to sites to resolve trial issues
Site
- Entering participant information, such as research data and patient’s background
- Reviewing and processing clinical trial data
Business Requirements
EDC solutions are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if CTMS integration and no coding are requirements, confirm that potential vendors will support those needs.
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