Tracking & Reporting
To ensure the most efficient and timely execution of the imaging component of the clinical trial process, RadPharm implemented RadSTART as a natural evolution of our legacy work flow management system. RadSTART is a vertically integrated technological suite of solutions to more effectively track and manage
the media process for our sponsor’s projects. Project information is expedited and team communication
facilitated through the creation of customized reports available to sponsors through a secure web portal
in our sponsor eRoom.
This second generation tool can effectively monitor and manage the results of multiple ongoing trials and provides web access to project information in a centralized database through a secure portal. The
evolution
of our innovative system is significant as it simplifies the process and the overall complexity of
the
technology to gain real-time access to a broad range of diverse patient information being collected in multinational phase
I-IV trials today.
The tool allows visibility of the status of critical documents and the overall performance metrics of a given project. Further, the architecture of the model drives internal efficiency throughout our global clinical
operations to include imaging operations, quality assurance, medical affairs, data management and
regulatory affairs. This state-of-the-art application sets RadPharm apart as we continue to invest in technological innovation to ensure we are delivering on our commitment to quality, cost efficiencies and
overall adherence to our sponsor’s project timelines.
Pharmaceutical and Biotech companies are increasingly looking to partner with vendors employing
innovative, real-time tracking systems to enhance communication and improve their overall decision
making paradigm
System Benefits
Enhanced operational productivity:
- Relational Database: RadSTART allows for multiple data elements on a single screen. This
visibility reduces process cycle time and an overall reduction in errors.
– Tighter Data Controls: Enforces all rules from the on-set of a project to maintain data integrity.
- Scalability: Supports large global implementations including multi time zone, and cross
functional departments in a matrix environment.
- Internal Reporting: The project ‘dashboards’ allows management teams to extract critical
information such as media turnaround time and internal productivity metrics. This business
intelligence tool allows management to become proactive instead of reactive to changes in the business.
- Bar Coded Media Tracking: Affords the ability to track media with bar code scanning technology
which assures accuracy and reduce errors. It provides instant visibility into Media location and
provide early detection of potential bottlenecks.
Sponsor Benefits
- Interaction and Reporting Capabilities: Our partners can check the status of media, of completed reads and raise questions when necessary. In addition, the model enables collaborative
interaction allowing our sponsors to filter and sort reports in a controlled environment.
- Transparency: The 24/7/365 tracking tool allows for determination of media status, read status,
post read status, levels of adjudication and facilitates project team communication.
- Certified Compliance: The Oracle/Siebel eClinical vertical integration has been certified and offers essential functions required in the heavily regulated Pharmaceutical industry. All audit trails have
been certified by Oracle as FDA compliant.
- Decreased Cycle Time for Reads: RadSTART implementation provides a lean, paperless
business process that will reduce the overall cycle time for media processing.
 Standard Reports
- Media Receipt Report
- Open Issues Report
- Missing Cycle Report
- Site Status Report
- Subject Status Detailed Report
- Subject Status Summary Report
RadSTART delivers a higher degree of customization to support variable protocol rules for our sponsor partners to include:
 More fluid workflow processing
- Multiple read types
- Improved access of trial data
- Easier adaptation to mid-study changes
- Creation of Media, Read and Post-Read workflow
- Creation of multiple timepoint schedules to accommodate a study with multiple arms and multiple timepoint schedules.
- Barcode functionality to track media
- Enhanced library check-in and check-out functionality
- Imaging Facility Qualification workflow
RadPharm is committed to build upon its reputation and legacy within the drug development industry to provide unprecedented customer service and satisfaction through its people, internal process and continued application of innovative technology.
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