The Future of Clinical Trial Oversight

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3 min read

Jun 22, 2022

The life sciences industry has seen an unprecedented shift to decentralized clinical trials—a change that is now commonplace. Sponsors and CROs now require digital clinical operations solutions that provide a comprehensive yet flexible approach to clinical trial oversight, balancing the need for both on-site and remote capabilities.

Medidata is powering this flexible approach to efficiently maintain control of data integrity and patient safety. We have been preparing for this new future of clinical trial solutions for 20 years. This expertise and dedication has resulted in the industry’s most comprehensive approach to quality clinical trial oversight and process control: Medidata Digital Oversight.

What Clinical Trial Monitoring Activities Does Medidata Digital Oversight Support?

Digital Oversight supports source data verification, source document review, on-site monitoring, remote monitoring, centralized statistical monitoring, and risk assessment and monitoring.

What Comprises Medidata’s Clinical Trial Oversight Offerings?

Medidata’s Digital Oversight consists of the following solutions:

Medidata Risk Management – Identify, document, and measure study protocol risks and devise a monitoring plan.
Medidata Detect – Perform comprehensive, continuous data and risk oversight leveraging advanced analytics and machine learning capabilities.
Medidata Remote Source Review – Off-site review of critical source documents.
Medidata Rave TSDV – Design, configure, and execute a highly-targeted source document verification strategy.
Medidata Rave CTMS – Standardize trial management and clinical trial monitoring activities at the study, country, and site levels.

How Does Digital Oversight Support Decentralized Clinical Trials (DCTs)?

Decentralizing technologies support both sponsors and patients when running robust DCTs. Patient-level decentralization focuses on patient-facing elements that occur outside traditional research sites, while sponsor-level decentralization includes remote technologies to improve workflow for study teams off-site. Remote source review and Medidata Detect are remote monitoring solutions that give CRAs and central monitors remote access to review study level data anomalies and critical source documents.

What Is the Value of Digital Oversight?

Medidata Digital Oversight is the most comprehensive risk-based monitoring strategy available. Digital Oversight allows for a flexible on-site/off-site approach to data quality oversight and process control. All stakeholders benefit from remote monitoring in clinical trials, as this saves time and reduces costs for on-site visits and monitoring.

Source data is captured directly in EDC and reviewed remotely by study teams. Interaction between sites and CRAs is improved. Sites are freed up to spend more time with patients. And CRAs are alerted to any irregularities in data while possessing powerful analytics to enhance decision-making.

Can I Still Use Digital Oversight if I’m Not Going Fully Remote on a Study?

Yes. Although decentralized technology is here to stay, there are still many clinical trials that require on-site visits as part of their trial protocol. Medidata recognizes that many trials are hybrid. Our innovative Trial Dial™ framework lets you customize your clinical trial design to find the ideal mix of on-site and decentralized elements for your study—and Digital Oversight accounts for this.

Oversight activities begin with a comprehensive risk assessment to identify critical data and process, as well as on-site study start-up activities. This is followed by central statistical data monitoring, virtual remote source review, live-video monitoring visits, and targeted, risk-based, on-site visits. Remote oversight and assessments have resulted in a dramatic reduction in on-site visits in some clinical trials.

Will I Need Multiple Logins for These Remote Monitoring Solutions?

No. Medidata’s decades of clinical trial expertise have culminated in the industry’s most comprehensive unified platform. We realize that working with multiple vendors and different technology solutions places an unnecessary burden on site staff to keep track of multiple logins and train on different software. Worse, device integration with disparate solutions is often rife with IT issues that cause delays and extra work.

A unified platform mitigates risk and reduces data transcription workload. Sites can expect one login and interoperability across all Digital Oversight offerings. Medidata’s decentralized solutions all unify directly with Medidata Rave EDC, which lets sponsors use direct eSource data capture for real-time information. Sites can log into Rave EDC and access data for monitoring in real-time as well, without needing data reconciliation.

What About Data Security and Compliance?

Medidata’s Remote Source Review provides multiple levels of data security and compliance.
21 CFR Part 11 compliant.
Protects personally identifiable information (PII) and personal health information (PHI) using redaction functionality to reduce errors.
Intelligent workflows and flexible permissions allow for automatic distribution of source documents to the correct monitors for the sites they’re assigned.
Complete audit log and documentation to track and re-verify data to protect against the risk of failing an audit.