Analytics and Visualization Enhance Clinical Data Management
Medidata Rave and other EDC platforms hold volumes of clinical research and clinical trials data. As electronic data capture (EDC) and clinical data management (CDM) systems, they help clinical trial teams to capture, manage, and report patient data.
To fully realize the value of the investment in an enterprise-scale EDC solution, clinical leaders often seek to leverage EDC data for a wide range of analytics challenges. They aim to use EDC systems like Rave for Medical Monitoring, Risk-Based Monitoring, to optimize Clinical Trials Operations, and more.
Electronic Data Capture for Pharma & CROs
As the gold standard for EDC in global, complex, randomized clinical trials, Rave is a comprehensive solution to a major industry challenge for large and mid-sized pharmaceutical companies and contract research organizations.
But are users getting all the insights they can from Rave’s tool set? Does it support full clinical data review, risk-based monitoring, and more? Could users benefit from purpose-built applications that enhance data-driven insights?
After implementing an EDC system and ensuring baseline requirements are fully met, it can be disappointing to learn there may be gaps that demand additional solutions. Yet, as the number of clinical trials grows, the importance of having the right informatics to heighten and speed information-to-insight in clinical operations becomes critical. Estimates are that the global e-clinical solution software market will reach $6.51 billion by 2020, due to an escalation of clinical trials data.
"When speaking with our pharma and CRO clients, I’ve found that the majority require more powerful solutions for RBM and CDR. It really comes down to the need for deeper levels of understanding with operational risks and how to quickly adapt and act on them,"
said Masha Hoffey, Director of Clinical Analytics at PerkinElmer..
Expanding the use of a deployed solution like Rave to cover additional medical review and RBM requirements can be risky. It is not always clear:
What the user requirements for the expanded use are.
What requirements Medidata supports out of the box.
Which requirements may need additional services.
Which requirements are supported if Rave is implemented using predefined standards.
While there is nothing wrong with using predefined standards, there is the risk that they compromise flexibility. What’s more, the decision to use the predefined standards often has to be decided at such an early phase in the Rave implementation that there is a good possibility such standards will not meet your immediate or future needs.
Five-Step Gap Analysis
A proven way to assess whether to use Rave’s standard analytical and visualization capabilities versus an alternative solution is to perform a five-step gap analysis:
- Identify the use cases for analytics and visualization in your medical review and/or monitoring workflow
- Spell out the user requirements
- Map Medidata Rave capabilities to those requirements
- Identify requirements that are not supported
- Consider alternative solutions that offer connectors to Rave to mitigate any gaps
Complementary solutions, like PerkinElmer’s Clinical Data Review (CDR) and Risk-Based Monitoring (RBM), with seamless connectivity to Rave, are purpose-built for clinical operations and safety teams.
These solutions, with built-for-purpose analytics and visualization capabilities, offer necessary capabilities such as:
CDR
360º view into patient profile, adverse events, and other safety domains
Optimized data surveillance across functional teams
Ensured high-quality data for faster database lock
RBM
Adaptive risk model
Advanced and predictive analytics
Alignment with TransCelerate's RBM initiative
Closed-loop workflow in one system
This means you don’t have to manually export data from Rave, because the Connector for Medidata Rave can extract, transform, and load Rave data into TIBCO® Spotfire for clinical analytics and visualization. Using the standard CDISC ODM (Clinical Data Interchange Standards Consortium – Operational Data Model) format facilitates the regulatory-compliant acquisition, archiving, and interchange of metadata and data for clinical research studies.
Working together, Medidata Rave and PerkinElmer provide a more complete, accelerated view of clinical data, increasing the overall quality and speed to insights while leading to better decisions from the Rave data.
Want to supercharge your RAVE clinical data? Compare your gap analysis to our Clinical Solutions or contact us to better understand your requirements.