Clinical Trial Solutions
LabAnswer Goes Beyond the Clinical Laboratory to Provide Complete Clinical Trial Informatics Solutions
Automation for Clinical Trials Systems
The goal of clinical trial informatics is the smooth flow of data through all processes while minimizing risks associated with electronic data capture and maintaining data traceability for regulatory submissions. This integration works with ever changing technologies and platforms, both commercial and proprietary. KPIs and metrics are established for benchmarking and informed decisions.
LabAnswer understands the processes and technologies required to maximize the integration of systems and sharing of trial data to support the most dynamic and automated implementations of clinical trial management. We recommend solutions that best fit our clients' unique needs. This includes off-the-shelf products as well as custom and hybrid systems meeting the core needs of trial execution and laboratory testing. Our solutions focus on the ease of operation, the soundness and security of data and the ultimate delivery of results to drive additional research and treatment decisions.
Protocol Definition and Study Design
LabAnswer's clinical trial expertise can implement solutions that help communication to a Clinical Research Organization (CRO) or any contract agency to better perform and manage the study.
- Enhance a detailed study design
- Document and track protocol milestones
- Improve layout of visit path and testing schedule
- Manage site participants and Institutional Review Board (IRB) information
- Control user access by clinical role
- Enable and manage the impact of amendments and extensions to the protocol during the study
Patient and Specimen Data
LabAnswer’s clinical and laboratory systems expertise can help your organization maximize the value of the data captured during the trial by utilizing sophisticated informatics and analytics tools:
- Create the framework for a massive clinical data repository for patient and specimen data
- Manage blinded data to prevent scientific bias
- Ensure compliance for privacy data access limitations to protect patient confidentiality
- Create a dual coding scheme to protect patient identity in relation to genetic information compliance
- Create an array of data mining tools that incorporates study, patient and specimen data to better enable research resources and specimen retrieval.
CRO Systems Share Data
Systems that can be fully integrated to share trial data and support trial management include:
- Study protocol / patient management
- Kit production
- Kit accessioning
- Core laboratory
- Data access and reporting
- Bio specimen storage