Challenge
Clinical Trials Resource Group (CTRG), a CRO with 120+ cumulative years of ophthalmology-specific experience, embarked on a complicated, multi-site trial comparing two distinct treatment groups.
The two groups had varied treatment schedules with the potential for adjustments. To be successful, CTRG needed flexible and dynamic solutions to support study management.
Download the PDF version of the CTRG Medrio Case Study.
Solution
Efficient processes and quality data are central to CTRG’s success. To uphold these standards, CTRG utilized Medrio CDMS/EDC and RTSM. Recognizing the importance of deep knowledge and expertise, they also leveraged Medrio’s data management and biostatistics services.
Together, we achieved operational excellence, accelerated study timelines, and consistently maintained submission-ready data.
As a result, CTRG experienced:
- Operational excellence: Ability to support complex study designs for efficient, quality outcomes
- Accelerated timelines: Streamlined workflows while removing administrative burden
- High-quality data: Delivered clean, submission-ready data consistently
Metrics & Results
With Medrio, CTRG experienced enhanced study flexibility, improved site efficiency, and robust data integrity.
| 38% faster build times | 50% eCRF reutilization | 90% real-time data cleaning |
“The data management team really stays on top of the data. Many vendors I’ve worked with wait till the end of the study to code, issue queries, and clean the data. With Medrio, our reports showed 90% real-time data cleaning, significantly helping our team and decreasing database lock timelines.” – Crystal Gates, Director of Clinical Operations at CTRG
Enhanced Study Flexibility
For a complex study with intricate study design requirements, Medrio’s consultative approach and robust features enabled operational excellence.
Build support decreased study timelines while enhancing predictability and data quality. Additionally, mid-study changes were quickly tested and executed, keeping studies on track regardless of what arose.
Features and support include:
- RTSM treatment group configuration support
- Study build support
- eCRF templates
- User Acceptance Testing (UAT)
“Our partnership with Medrio helps us decrease timelines, especially with regard to study builds. Instead of taking 16 weeks, we’ve built studies in 10 to 12 weeks. Plus, real-time data management keeps our data clean and decreases database lock time. It’s a huge success!” – Crystal Gates, Director of Clinical Operations at CTRG
Improved Site Efficiency
User-friendly features and integrated data workflows enhanced data quality and reduced administrative burden.
A seamless process from data entry to management created a positive site experience while ensuring data integrity. Single sign-on also provided efficient transitions between solutions with a click of a button.
Features and support include:
- Skip logic, dynamic forms, and auto-querying for blank fields
- IP reconciliation and training certificate management
- Single sign-on
Robust Data Integrity
CTRG’s high data quality standards were supported by Medrio’s proactive data management approach. Real-time data cleaning and high query resolution rates improved data quality and reduced database lock time.
CTMS integration facilitated data flow and accurate tracking of visits and SAEs. Risk-based monitoring enabled customized monitoring plans, ensuring high-quality data and reducing on-site monitoring costs.
Features and support include:
- Proactive data management
- Real-time data cleaning
- CTMS integration
- Risk-based monitoring support
“Our Medrio and CTMS integration pulls over the visit and SAE information as they occur. This integration significantly helps with reconciliation while ensuring visits are monitored, and all reports are correct.” – Crystal Gates, Director of Clinical Operations at CTRG
Download the PDF version of the CTRG Medrio Case Study.
