Every clinical study generates extensive data captured on varied platforms like eCRF, CTMS, eTMF, safety database, IWRS/IVRS, laboratory data and site records. This independently gathered but related information can carry potential triggers to impact data quality, integrity and subject safety. Although monitors, study managers, data validators, medical monitors, statisticians and other study personnel review this data from time to time; the review is often independent, non-synchronized and conducted by differenet personnel at different times in the study, thus increasing risk of missing vital triggers that may affect subject safety and study outcomes. A holistic overview of data tends to be an "end of study" activity by which time, oppurtunities to intervene, correct and improve have passed.
Wide-Angle-Data Review Platform is a Central, Integrated Data Review Platform that uses Risk Management principles based on ISO 31010 guidelines as the central theme. Data from different sources are integrated on a single review platform providing an opportunity to remotely review holistic study data in a real time setting.
- Conceptualized, developed, tested and validated by team of experienced clinical trial professionals
- Integrates data from legacy and commercial clinical data management systems, CTMS, safety management systems, IWRS, laboratory data and other data source platforms
- Enables program level, study level, country level, site level and subject level, data review
- Has a flexible drill-down approach to proceed from overall data review to profile, parameter, visit, subject and event level data scrutiny
- Enables selection of single or combination of datasets for review
- Utilizes cross functional validation checks placed for holistic data surveillance and queries
- Employs unique data reduction techniques to focus on the most critical data
- Has an inbuilt risk engine to facilitate constant updating of risks throughout the study and/or Clinical Development Program
- Applies multiple statistical tools for trending and graphical data review
- Facilitates real time cross-functional data review by key study personnel (monitors, study managers, medical monitors, statisticians and other study personnel)
- Enables assessment for conformance to CTCAE criteria
- Simplifies review of coded data
- Supports review of scales
- Auto-classifies patient data for easy review
- Facilitates availability of patient profiles
A central data review platform is not a new concept. Wide-Angle-Data, however, incorporates several unique features which sets it apart from conventional data review platforms.
- Data Reduction: The platform uses proven ‘Data Reduction’ techniques which highlights the most critical data to be reviewed from the entire block of data. The critical data is identified based on time tested data review concepts which are translated into multiple algorithms by a group of medical professionals. This well thought out categorization helps a reviewer focus on significant outliers, thus increasing the efficiency of data review!
- Statistical Concepts: The data review is not just limited to routine review of outliers and trend analysis. Inbuilt within the system are multiple statistical methods and concepts which are applied during review, thus giving the correct statistical basis for clinical data review.
- Risk Management: Wide-Angle-Data houses an inbuilt risk engine which helps identify early risk triggers. This pre-defined engine carries critical risk elements based on DiagnoSearch’s rich clinical research experience. Additionally, Wide-Angle-Data facilitates seamless integration of data on a single platform, aiding a consolidated review by all key study personnel. The reviewers can examine concerns, raise issues, post them for peer review, perform root cause analysis and narrow down the potential risks which get updated into the statistical risk engine on a real time basis.
The data reduction techniques and simultaneous real time data review by key study personnel ensures subject safety and data quality. In addition, early identification of study trends and risks enables a decision maker’s timely intervention to positively influence study outcomes and significantly impacts timelines and costs.