elluminate CTMS Fact Sheet by eClinical Solutions

Fact Sheet

CTMS Insights

Own, access and leverage all your operational data

elluminate® CTMS Insights provides organizations with outsourced models with one place for trial operations data, without the burden of traditional clinical trial management systems. Right-sized for efficiency at any scale, elluminate CTMS Insights integrates operational data from a wide variety of sources by leveraging the interoperability of the elluminate platform. With ONE central place for all your trial operations data, plus self-service analytics, your team can proactively manage trials, risks and oversight across the portfolio. Benefits Increase Operational Oversight

Improve Trial Performance

Optimize Resources

■ One source for all your operational data, including data from your CROs and from EDC, IVRS, eCOA and other systems

■ Mine and analyze your investigator data, augmenting it with every study you do

■ Gain the benefits of CTMS without unwieldy, overly broad functionality that’s difficult to implement

■ Real-time visibility to metrics showing how sites perform ■ Platform approach eliminates the need for siloed clinical and operational data repositories, enabling teams to leverage data for applications such as RiskBased Quality Management and Monitoring

■ Access your own investigator database with master data management capabilities, in addition to analytics provided by your CRO, to optimize investigator relationships ■ Manage data at the investigational product, program and study level, for analytics that inform new study startup plans and site selection

■ Add new data being managed internally or adjust entries received from other sources ■ Maximize study planning and performance management with operational data for current trial oversight and a variety of baseline, planned and actual metrics that increase in value over time

Fact sheet – elluminate CTMS Insights

Study dashboards track key study timelines with visualizations such as planned vs actual

Key Study Timelines - Planned vs Actual (19-033)

Final Protocol to FPI

FPI to LPI

FPI to Final DBL

22 20

ct O

l Ju

1 r0 Ap

21 20

ct O

l Ju

1 r0 Ap

20 20

ct O

l Ju

1 r0 Ap

Planned Months

Actual Months

Features Operational Data Repository

Investigator Database

Self-Service Analytics

■ Automate your operational data flow to one central platform and harmonize via a metadata rulesdriven engine

■ Unique Site and Investigator identifiers across your portfolio

■ As part of the elluminate platform, CTMS Insights includes self-service visualizations to meet the needs of your team and portfolio

■ Operational data from CRO-managed studies are automatically integrated, scheduled and verified ■ Seamless CTMS integrations from Covance, PPD, Medidata and Veeva, with other integrations in development

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■ One centralized place for operations team to review investigator information to inform future enrollment and startup plans ■ Information on investigational products, programs, trials, sites, investigators, and personnel are available for review and analysis

■ Access and insight into operational data from numerous places across and outside the organization ■ Interact with real-time data so you can perform what-if analysis and proactively manage risk

Fact sheet – elluminate CTMS Insights Core capabilities included as part of the elluminate Clinical Data Platform ■ Automated Clinical Date Pipeline for Ingestion & Export – Out of the box interoperability with 20+ different clinical data systems, enables automated ingestion of data with standards conformance checks, along with data provisioning and exchange. ■ Centralized Data Repository – The core of the elluminate platform is a unified data hub–providing one place for all your data assets with near unlimited performance and scale, and a flexible data access model to support blinding needs and regulatory compliance. ■ Data Governance & Lineage – Complete transparency, traceability and data lineage are always available throughout the platform by showing the lineage of all data, transformation and metadata with self-documenting capabilities, including standards and specifications. ■ Computing Environment – A powerful computing environment with self-service mapping capabilities utilizes metadata for data standardization and automated mapping rules for publishing of standardized analytics and visualizations. ■ Workflow Engine – Queries, issues and notification creation and rules engine powers flexible, role-based workflows for data review ingestion and provisioning.

Learn More eClinical Solutions is a leading global provider of cloud-based enterprise software and tech-enabled data services. The elluminate platform is an end-to-end purpose-built clinical data platform at the forefront of the Life Sciences industry, helping companies evolve to manage the exponential growth of clinical data by leveraging modern and innovative technology. The elluminate platform and eClinical data services help to digitize and transform clinical data creating new insights and accelerated drug development for 100+ biopharmaceutical companies.

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