Comprehensive and Secure
Worldwide Clinical Trials offers the BioClinica® OnPoint CTMS. OnPoint enables tracking and reporting of all study activities through a secure, fully configurable, trial-specific application from study planning through close-out and FDA submission. It maintains control of role-based access by the Worldwide study team and the Sponsor. OnPoint supports every study aspect, including design, procedures, protocol, study arms, visits, forms and treatments.
Powerful and Flexible
Because most OnPoint interaction is through familiar Microsoft applications, training is minimal, with seamless bi-directional information exchange with SharePoint, Outlook, Excel, etc. All updates are reflected 360 degrees, so data is always accurate and current. Because our CTMS is cloud-based, you can view and manage near real-time operational performance at any time. It improves efficiencies in both data flow and work flow, yielding cost-savings in time and labor. Operational expenses also are reduced, because such “software as a service” (SaaS) products do not require purchase, installation, maintenance, and updating of software and hardware.
Key Features
You can:
- Access current information on site status, activation, enrollment, and monitoring visit schedule
- Connect, export, and collaborate securely
- Observe recruitment status and trial enrollment
- Intervene early in potential enrollment delays
- Manage planning and execution of monitoring visits, including visit windows
- Generate custom and ad-hoc reports, including an innovative Monitor Visit Report
- Securely access real-time data
The system provides:
- Systematic and consistent compliance management
- Flexibility to track critical events, documents, study/country/site/subject milestones
- Tracking of adverse events, action items, protocol deviations for sites and subjects
- Custom views, workflow, and alerts
- Full integration with all voice/web response tools, electronic data capture, statistical analysis systems, electronic patient-reported outcomes, adverse-event reporting, laboratory tools, etc
- Rapid set-up
- Automatic generation of monitoring reports
- Management and tracking of investigator payments
Our CTMS can help:
- Ensure strong financial performance and maintenance of good relationships with investigators and site personnel
- Ensure study close-out is compliant with your standard operating procedures and with federal or international regulations.
Our clinical trials management system can facilitate trial life cycles by establishing efficient processes that reduce costs and deliver rapid return on investment.