Adopting digital tools in clinical research is no longer a question of if, but when. From site start-up to data collection and monitoring, systems like eCRD, CTMS, ePRO, and eTMF help streamline operations, improve compliance, and reduce administrative burden.
But how early should these systems be introduced into your study timeline? At Xolomon, we often hear this question from sponsors, CROs, and research sites. The answer: as early as possible, but with purpose.
Here’s a breakdown of when and how to implement your clinical trial software for maximum efficiency.
During study planning: define your digital infrastructure
Before protocol finalisation, trial teams should already be thinking about which digital platforms they’ll use. Why?
• To avoid fragmented workflows later on
• To ensure protocol designs align with data capture capabilities
• To budget accurately for system licensing and training
This is the right moment to evaluate CTMS platforms (like Xolomon’s) to manage trial milestones, roles, and documentation from day one.
At site start-up: activate your CTMS and eTMF
Once sites are selected and documentation begins, it’s essential to centralise trial documents and site communications.
• A CTMS helps track approvals, contracts, and initiation timelines.
• An eTMF ensures that regulatory documents are version-controlled, securely archived, and inspection-ready.
Starting these tools too late often results in document backlogs and miscommunication, both of which can delay trial activation.
Before first patient in: set up eCRD and ePRO systems
Your eCRD (electronic Case Report Document) platform must be validated and configured before the first patient visit. This ensures:
• Real-time data capture from day one
• Standardised procedures across all sites
• Fewer transcription errors
If your study includes patient-reported outcomes, your ePRO tools should also be in place before recruitment. This allows patients to report directly from mobile or web-based platforms, improving engagement and data quality.
Throughout recruitment and follow-up: monitor and optimise
Once your study is live, digital tools help maintain momentum:
• CTMS dashboards allow project managers to detect delays early
• eCRD audit trails ensure data integrity
• ePRO adherence tracking supports patient retention strategies
Digital systems aren’t just for start-up; they add value across the entire trial lifecycle.
The bottom line
The biggest mistake many teams make is introducing digital tools too late in the process. This leads to rushed implementations, lost data, and poor user adoption.
With Xolomon’s suite of clinical trial tools, you can simplify every stage, from planning to close-out, with one integrated platform.
The right time to go digital? Now.
