Veeva Systems Inc.

06/18/2021 | News release | Distributed by Public on 06/18/2021 06:27

Three Ways Vault EDC Supports Decision Making in Oncology Trials

Decision Making

Oncology trials are 30 to 40% longer than other drug trials and undergo more internal reviews than other protocols (Tufts CSDD, May 2021.) Vault EDC provides Review Assessment to speed up data review as well as QuickView and Medical Coding to help you run more efficient oncology trials.

Complicated patient journeys make for complicated data review. Rather than providing CRAs and data managers with the same screen as the site, meaning they must review the data page by page or extract it out from EDC, Vault EDC users have dedicated user- experiences, like QuickView and Review Assessment. QuickView is the simplest way for CRAs and Data Managers to review data, at the visit level. Selecting a visit, apply the appropriate review filters (e.g. targeted monitoring, query status, etc.) and simply move from visit to visit.

Review Assessment
Too frequently data managers are forced to turn to SAS listings or worse, Excel spreadsheets, to manage review cycles. Whether this is a simple physician assessment or a clinical review process or perhaps a Data Monitoring Committee (DMC) or Data Safety Monitoring Board (DSMB) - too frequently we leave EDC to work offline.

Like QuickView, Review Assessment introduces a rule-based functionality, core to Vault EDC, that enables the study team to define data review workflows. These could be based on events, such as serious adverse events, or out of range lab values, or be more robust, like an end of cycle review. Speeding up data review in this manner drives acceleration of key decisions, such as dose escalation meetings, data safety monitoring committees, and in-stream data cleaning. Additionally, Vault EDC allows the study team to set email notifications to alert the team to any issues, such as safety considerations.

Medical Coding
Adverse events and concomitant medications form a critical part of the overall data assessment, meaning the ability to code in near real-time is increasingly important. Traditional EDC solutions frequently have a separate module for medical coding. This creates integration challenges and slows the process. Vault EDC solves these issues by extending the concept of user specific experiences into medical coding. It is one database, fully connected at all times.

Vault EDC is a unique system that enables you to build the oncology trials you need. Read How Vault CDMS Streamlines Data Collection for Oncology Trials.