Pankaj Blog

Make Better Data-Driven Decisions with a Holistic View of all Clinical and Operational Data

By Pankaj Manon, CTO/Founder, ThoughtSphere

Introducing ThoughSphere Cloud V1.6

With this blog, I am proud to announce the latest release of ThoughtSphere Cloud V1.6, generally available February 2020. The highlights of V1.6 are new functionality and capabilities across these four areas:

  • Operational Data Repository
  • Standards Alignment
  • Triggers and KRIs
  • Security with Single Sign-On / SAML Support / and OAuth Support

A key challenge we recognize sponsors and CROs face is the overwhelming variety and volume of data – both clinical and operational – and how a lack of insight into these data prolongs clinical trial processes. On the operational side, clinical trials generate project management data, electronic trial master file (eTMF), regulatory data, financial data, employee data, etc. and sponsors use these data to make informed decisions. For example, they might ask these type of questions:

  • Are essential documents being captured, such as The Statement of Investigator Form, FDA 1572, or non-disclosure agreements (NDAs)?
  • Do we have enough patients? Are we meeting enrollment targets?
  • Do we have adequate facilities and staffing?
  • How long is it taking to start the study and how much staff time is involved?

Being able to answer these questions and many others related to operational data can help sponsors and CROs optimize trial operations and improve cost and resource efficiencies.

In ThoughtSphere Cloud V1.6 we have significantly enhanced our operational data repository where sponsors and CROs can ingest operational data into our big data, data lake architecture and aggregate and standardize these data. A non-technical person with business knowledge of the study can do this, with no coding, as it is all configuration based. Users can configure data domains to load any kind of data. Once the data is loaded, we provide an operational workbench to transform the data and then users write aggregation scripts to aggregate the data.

The ultimate goal is to provide study teams access to this data for advanced analytics. By analyzing the data, sponsors and CROs can make better decisions about how a trial is being conducted, maintain more effective and successful clinical trial processes, and gain a better and quicker understanding of issues and risks and take actions to mitigate those risks. Also, with access to the data and the ability to take advantage of the advanced analytics capabilities we offer, we believe our clients can drive innovation.

The second significant area of functionality in this release is we have aligned our clinical trial milestones and metrics to an industry standard – Align Clinical CRO. Align Clinical CRO is a life sciences industry standards group, established to make clinical trials run by CROs on behalf of an industry sponsor more cost-effective and efficient. Their Operational Data Exchange Standard defines the data and structure to consistently and easily exchange data between CROs and sponsors. This is an important capability for study teams, specifically those in clinical operations. The milestones and metrics are in various categories:

CategoryMilestone

(Examples)

Metric

(Examples)

Data QualityDatabase Activation Date
Database Lock Date
EDC Query Metrics

Data Entry Delays

SDV Completion Percentage

MonitoringSite Activated Data

Edit Checks Complete Date

Site Initiation Visits

Site Interim Monitoring Visits

Site Closeout Visits

RecruitmentFirst Subject First Visit Date

First Subject Screened Date

Enrollment Rate
Screen Failure Ratio
Discontinuation Rate
RegulatoryProtocol Submission Date

Regulatory Packet Complete Data

SafetySerious Adverse Reactions

Protocol Deviations

StudyFinal Protocol approval

Site Milestones – First Site
Selected, Activated etc.

Sites Activated Count

Subjects Completed Count

The benefits, of course, of having this information is sponsors and CROs are able to quickly visualize the milestones that are being met or missed and observe key metrics. Today, having this information readily available is done through a data warehouse and can be tedious and cumbersome.

The triggers (key risk indicators) in the platform proactively identify operational risks by applying quantitative measures on the aggregated source data. It also notifies the users of potential safety and performance issues at the site by means of actions, risk reviews and site review dashboards. With this release we have enhanced the trigger functionality such that all the site comparative triggers can be configured to monitor site performance using relative and standard deviation thresholds. In addition, the milestones and metrics based triggers are now aligned to the industry standard – Align Clinical CRO.

To close out the release we have added single sign-on support. This enhancement is key to our commitment on providing a secure platform and keeping it simple for users. Our clients use various IT platforms to support the complex business of running clinical trials. End users who have to navigate through multiple systems can seamlessly login into these systems with single sign-on enabled. With this release the ThoughtSphere platform can be configured to support SAML or OAuth based single sign-on authentication.

I want to thank the R&D team here at ThoughtSphere for their great work on ThoughtSphere Cloud V1.6. The platform they have built is making a difference in the industry and their innovation will continue to drive results with our sponsor and CRO clients. If anyone wants to learn more about ThoughtSphere Cloud V1.6, please reach out to me at pankaj.manon@thoughtsphere.com

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