iRIS (ICON Results Integration Services) enables the collection of synchronised data from local laboratories into one central database for streamlined analysis and expedited regulatory submission to meet the demands of today’s clinical trials.
Challenges in collecting local laboratory data
Sponsors need to access complete, high quality, uncompromised data in a timely manner, expending as few resources as possible in the process. While local laboratories perform a necessary service in managing individuals with highly compromised health, often in need of same-day laboratory results, collecting local laboratory data can be challenging.
The discrepancy and quality issues arising from working with multiple sites require special attention to data collection, issue resolution, and reporting. Sites are responsible for entering many types of information into the electronic Case Report Form system, including subject demographics and visit details as well as the actual results, units and normal ranges. Ideally, this would be executed flawlessly but, in reality, overworked sites are often in a rush, resulting in data entry errors such as missing and duplicate visits, inconsistencies in which tests are required for the protocol, and unreported tests or incorrect identification of performing laboratories. Such challenges are magnified when dealing with complex testing requirements at multiple sites.
Inconsistent reporting from lab to lab is masked without a centralised process. Multiple methodologies lead to different ranges and result value magnitudes – a problem which is hidden until the final analysis when data must be converted to a common unit.
iRIS - a qualified outsourced solution
iRIS offers a compelling approach for companies in need of a streamlined process and dependable, secure access to local laboratory data. Individual laboratories send their results to ICON’s central data management group who will handle the data transcription, automatically flag issues, use a pre-configured workflow for issue resolution and oversee the quality of the study data managers.
iRIS is truly a full service offering, providing comprehensive support to local laboratory data management, including:
- Investigative site setup and management
- Established systems built to capture demographic and study specific requirements
- IT infrastructure with worldwide toll free faxing
- Imaged file management
- Entry of results from imaged source data by lab experienced staff
- Built in system checks for logical results
- Mapping of results from performing laboratory
- Laboratory results and ranges sent to Sponsor
- Management of local laboratory certifications and accreditations
- Metrics and tracking reports
Bringing benefits to your trial:
A process that relies on centralised experts and automation will use fewer resources to both manage data and investigate issues, leading to significant cost savings. Internal resources are freed from the mundane tasks of resolving data issues and can be redeployed toward more sophisticated data analysis, including meeting the requirements for regulatory data submission.
The various quality checks built into a carefully designed system result in fewer scientific issues for the sponsor and lead to dramatically enhanced data quality.
Issues are identified earlier in the process because access to the source documents eliminates the need for on-site verification. This process speeds up the time to database lock.
Contact us to see how our iRIS application can ease site burden and provide advantages to your clinical and medical teams.
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