Unified Site Methodology Program
Standardizing Data Collection & Reliability across Sites
Data quality and assurance is the driving need of any clinical study. Lotus has pioneered a comprehensive Unified Site Methodology (USM) program that extends from protocol design through data collection to ensure data consistency, accuracy, and integrity. This disciplined, multi-tiered program minimizes variability and enhances data quality across and within study sites.
Unified Site Methodology (USM) Program Overview
Lotus’ USM helps study sites achieve greater alignment in data collection practices. Conclusive findings minimize uncertainty and allow Sponsors to make well-informed strategic development decisions with confidence.
Identify Key Endpoints and Critical Study Elements
- Determine critical endpoints and critical study elements essential for trial success
- Key study elements vary by trial type, therapeutic area, and endpoints. Examples include:
- Study drug administration
- Placebo response mitigation
- Allowable rescue medication and data collection prior to its use
- Administration and collection of rating scales
- Measurement of physical parameters (e.g., waist circumference)
Analyze Variability Drivers
- Identify factors contributing to variability in the measurement of the selected endpoint and critical study elements.
- Assess site-specific differences in workflow, personnel expertise, equipment, and other operational aspects.
Develop Standardized Training and Tools
- Create a study-specific training program design to minimize all of the identified sources of variability for the critical endpoints and critical study elements.
- Implement standardized data collection tools, checklists, and reference guides to enhance accuracy and consistency in data collection and reduce variability.
Leverage Comprehensive Site Training Programs
- Conduct in-depth, site-specific training to ensure uniform protocol adherence.
- Utilize interactive training methods, such as:
- In-person interactive sessions
- Online training modules
- Case studies and scenario-based training
- Practical demonstrations and instructional videos
- Comprehension assessments to confirm knowledge retention
Perform Centralized Data Reviews
- Regularly monitor and analyze collected data to identify inconsistencies, trends, and potential errors.
- Provide timely feedback to study site staff to promptly address concerns and reinforce best practices.
- Initiate targeted re-training when trends indicate recurring data collection issues
