Improved site relationship management
The goal of keeping clinical trials on track, on time and within budget is difficult to achieve when dissatisfaction by frustrated investigators results in their withdrawal from an ongoing study. Sponsors now recognize that ensuring investigator retention and recruitment strategies require an innovative approach to managing sites. The emergence of investigator portals enables sponsors to facilitate and streamline communications and collaboration with their study sites.
agCenter™ is the clinical research investigator site portal that significantly improves investigator satisfaction and enables sponsors to reduce the time and cost of clinical trial administrative management. From an intuitive dashboard, study site staff are provided with role-based access to information including TMF-related documents, training modules and records, feasibility questionnaires, and safety reports. Investigator self-registration enables sponsors to receive a steady flow on interested participants while improving relationships with existing investigators. Sponsors and site monitors can view study progress summary reports.
Cloud-based for fast deployment
As with all ArisGlobal products, agCenter is available as a cloud-based, hosted solution on the agOnDemand platform. For more than four years, agOnDemand has been providing best-in-class, cloud-based services to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.
Comprehensive study site portal
agCenter™ centralizes access to all critical trial data and documentation, helping sponsors to reduce the time and effort of managing study sites while giving investigators the confidence and assurance they are in receipt of necessary information .
Other key features and benefits include:
- Secure document management and eTMF functionality ensures all critical trial information is exchanged. Sponsors can leverage a rule builder and configurable workflow functionality to set up document access privileges. Prior to logging in, investigators receive email alerts informing them of new information available on the portal. Once logged in, an intuitive dashboard provides easy, role-based and study-based access to necessary documents. Investigators can return documents via email or by uploading them.
- Automated safety report distribution reduces manual efforts and associated costs of ensuring compliance with timely SUSAR notifications. Distribution can be limited to a single study or performed across studies at the product/substance level. agCenter comes bundled with the proven functionality of agXchange SIR, which comes fully integrated out of the box with ARISg and agClinical; links to other safety and CTMS systems are offered. Detailed transaction history reports can be generated for audit purposes or for the TMF.
- Streamlined site assessment and selection is achieved through the use of templates, which enable sponsors to develop, distribute and manage study-specific electronic feasibility questionnaires used in the review of recruitment and retention strategies. Investigators can fill out questionnaires online and sponsors and study monitors are able to score and generate reports for further analysis.
- Cost-effective training management is now possible as site monitors utilize configurable training workflows to maintain site personnel records, including the training provided to each person. Alerts can be set up to notify staff of required training and training overviews and audit trail reports can be generated.
- Improved investigator relationships is achieved with an investigator dashboard that provides a single entrance to all clinical applications an investigator will need, including EDC and operational data. Using single sign-on, site staff have a condensed view of what needs their attention after login.