Introduction
Early-phase clinical research centers face unique challenges: complex protocol designs, tight timelines, high data quality expectations, and increased regulatory scrutiny. Sites still relying on paper or disconnected systems often struggle with inefficiencies that impact recruitment, protocol compliance, and billing accuracy.
Unlike other platforms, Trial360 integrates all critical modules (CTMS, eSource, CRM, finance) into a single solution, adapting to Latin America’s regulatory and operational specificities.
That’s where eSource and digital protocol workflows come in
With platforms like Trial360, early-phase sites digitize source documentation, automate visit scheduling, and standardize protocol execution. This ensures that staff always follow the correct procedures at the right time for the right patient. There will be no more chasing paper, re-entering data, or scrambling to meet deadlines.
The results?
- Faster study activation
- Reduced protocol deviations
- Real-time access for monitors
- Seamless billing and reporting
Below, we explore five key challenges Phase I sites face and how digital tools like Trial360 are helping streamline operations while ensuring compliance and data integrity.
Real-Time Data Collection and Source Quality
Challenge: Manual transcription leads to delays, inconsistencies, and data integrity issues.
Solution: With eSource, data is captured directly at the point of care—reducing errors and boosting quality from the start.
Complex Protocols & Multiple Visits Per Subject
Solution: Trial360 automates visit workflows and task management by user role, ensuring protocol adherence and reducing the burden on coordinators.
High Subject Turnover and Multiple Cohorts
Solution: Our smart scheduling functionalities allow tracking by cohort, visit window control, and real-time alerts—so nothing falls through the cracks.
Per-Visit Payment and Financial Control
Solution: Integrated financial and billing modules ensure accurate reconciliation and real-time visibility of site payments.
Real-Time Monitoring & Continuous Audit
Solution: Monitors and QA teams access data remotely, track audit trails, and verify source documents with electronic signatures—enabling ongoing compliance.
Built for Phase I Success
By embracing eSource and smart workflows, early-phase sites are moving faster, operating more efficiently, and exceeding sponsor expectations.
Want to see it in action?
References:
- ICH E6(R2) Good Clinical Practice – Sections 2.10, 5.0, and 8.3 emphasize the importance of quality systems, electronic records, and documentation traceability.
- FDA Guidance: Use of Electronic Health Record Data in Clinical Investigations (2023)
- TransCelerate Biopharma eSource Initiative – Promotes direct electronic data capture from the source for improved quality and compliance.
- MHRA Guidance on Good Clinical Practice (GCP) for eSource and protocol adherence in early-phase trials.
