Case study
Toronto Clinical Research Group (TCRG)
Eliminating duplicate data entry in a Phase 3 mental health trial.
Overview
Toronto Clinical Research Group (TCRG), a mid-sized research site located in downtown Toronto, participated in a Phase 3 clinical trial evaluating an adjunctive therapy for Major Depressive Disorder (MDD). The protocol required extensive clinician-rated scales (MADRS, HAM-D, CGI-S/I), daily ePRO diaries, multiple lab panels, and ECG assessments.
Despite using modern systems ™ EMR, ePRO, ClinCard, and the sponsor's EDC ™ coordinators were still performing large volumes of duplicate data entry, slowing operations and increasing the risk of transcription errors.
TCRG partnered with Nexa Trials to automate the eSource ? EDC data flow and eliminate redundant manual transcription.
The challenge
High-volume duplicate data entry across multiple systems
Before Nexa Trials, coordinators manually re-entered:
- Clinician scale scores from paper worksheets ? EDC
- Vitals and ECG results from EMR ? EDC
- Lab values from PDF reports ? EDC
- ePRO diary summaries ? EDC
- Dosing timestamps ? EDC
On average, each MDD participant generated:
- ~1,450 data points over the 12-week study
- ~900 of those were duplicate entries
- 3.5 hours of manual transcription per visit
This resulted in:
- Frequent transcription errors
- High CRA query volume
- Delayed data entry completion
- Staff fatigue and overtime
- Slower database lock timelines
The site director estimated that 30™40% of coordinator time was spent on redundant data entry.
The Nexa Trials solution
Automating eSource ? EDC for all major data streams
Nexa Trials deployed its automation layer across TCRG's existing systems:
- eSource Integration
- EMR-to-EDC Mapping
- Lab Report Parsing
- Clinician Scale Digitization
- ePRO Summary Automation
Key automations included:
- Clinician scales automation ™ MADRS, HAM-D, and CGI scores were captured digitally and auto-populated into the EDC with full audit trails.
- EMR ? EDC sync ™ Vitals, ECG timestamps, and medical history fields were mapped and pushed directly into the EDC.
- Lab report extraction ™ PDF lab reports were parsed automatically, preserving reference ranges, units, and abnormal flags.
- ePRO summary automation ™ Daily mood diaries and adherence logs were summarized and synced without coordinator involvement.
- Real-time query prevention ™ Nexa validated ranges, units, and required fields before data reached the EDC, preventing downstream queries.
Implementation
Timeline: 14 days
- Days 1™3: Workflow mapping, system access, and data dictionary alignment
- Days 4™7: Automation buildout for scales, vitals, and labs
- Days 8™10: EDC integration and validation
- Days 11™14: Staff training and go-live
No system replacement was required ™ Nexa layered onto TCRG's existing tools.
Results
Massive reduction in duplicate data entry
After implementing Nexa Trials:
- 92% of duplicate data entry eliminated
- 3.5 hours ? 18 minutes average data entry time per visit
- 78% reduction in transcription errors
- 61% fewer CRA queries
- Data entry backlog cleared within 2 weeks
- Database lock achieved 9 days faster than previous MDD studies at the site
Coordinator feedback
“This is the first study where I didn't spend my evenings catching up on EDC entry. Nexa removed the most painful part of my job.”
Sponsor feedback
“The clean data and low query volume were noticeable from week one. This site became our top performer.”
Conclusion
By automating duplicate data entry across scales, labs, EMR, and ePRO, Nexa Trials transformed TCRG's operational efficiency. The site completed the Phase 3 MDD study with:
- Faster data entry
- Fewer errors
- Happier staff
- A reputation for clean, timely data
TCRG has since made plans to expand Nexa Trials automation to all other new studies including neurology, metabolic, and oncology trials.
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