REGULATORY & QUALITY ASSURANCE
Audit Ready at All Times
Go beyond document storage—run internal QC checks and ensure continuous compliance with a robust eISF
REGULATORY & QUALITY ASSURANCE
Audit Ready at All Times
Go beyond document storage—run internal QC checks and ensure continuous compliance with a robust eISF
REGULATORY & QUALITY ASSURANCE
Audit Ready at All Times
Go beyond document storage—run internal QC checks and ensure continuous compliance with a robust eISF
Complete Regulatory Oversight from Startup to Closeout
Easily manage IRB submissions, approvals, training, advertising compliance, and more—without bouncing between systems or folders. SiteCentric’s Regulatory Manager gives your team a centralized, intuitive workspace with built-in alerts and automated workflows to keep every study on track and in compliance.
Complete Regulatory Oversight from Startup to Closeout
Easily manage IRB submissions, approvals, training, advertising compliance, and more—without bouncing between systems or folders. SiteCentric’s Regulatory Manager gives your team a centralized, intuitive workspace with built-in alerts and automated workflows to keep every study on track and in compliance.
Complete Regulatory Oversight from Startup to Closeout
Easily manage IRB submissions, approvals, training, advertising compliance, and more—without bouncing between systems or folders. SiteCentric’s Regulatory Manager gives your team a centralized, intuitive workspace with built-in alerts and automated workflows to keep every study on track and in compliance.
Modern eISF with Controlled Acccess for Auditors and Monitors
Our electronic Investigator Site File (eISF) is built for real-world site operations. Upload, categorize, and mark documents as reviewed. Stay ahead of expirations with proactive alerts. Enable remote monitor access with configurable permissions and activity logs. It’s everything you need to simplify document management and inspections.
Modern eISF with Controlled Acccess for Auditors and Monitors
Our electronic Investigator Site File (eISF) is built for real-world site operations. Upload, categorize, and mark documents as reviewed. Stay ahead of expirations with proactive alerts. Enable remote monitor access with configurable permissions and activity logs. It’s everything you need to simplify document management and inspections.
Modern eISF with Controlled Acccess for Auditors and Monitors
Our electronic Investigator Site File (eISF) is built for real-world site operations. Upload, categorize, and mark documents as reviewed. Stay ahead of expirations with proactive alerts. Enable remote monitor access with configurable permissions and activity logs. It’s everything you need to simplify document management and inspections.
Automate Study Milestone Tracking
Track study startup milestones, IRB approvals, regulatory documents, and SIV readiness—all in one place. Assign tasks, monitor status, and identify delays early to avoid bottlenecks. SiteCentric makes milestone tracking visual, actionable, and collaborative.
Automate Study Milestone Tracking
Track study startup milestones, IRB approvals, regulatory documents, and SIV readiness—all in one place. Assign tasks, monitor status, and identify delays early to avoid bottlenecks. SiteCentric makes milestone tracking visual, actionable, and collaborative.
Automate Study Milestone Tracking
Track study startup milestones, IRB approvals, regulatory documents, and SIV readiness—all in one place. Assign tasks, monitor status, and identify delays early to avoid bottlenecks. SiteCentric makes milestone tracking visual, actionable, and collaborative.
Ad Approval & IRB Compliance Built In
Never risk running unapproved ads again. SiteCentric connects your regulatory and recruitment workflows so that every outreach campaign is reviewed, approved, and documented before it goes live. Safeguards and warnings flag anything that’s out of compliance.
Ad Approval & IRB Compliance Built In
Never risk running unapproved ads again. SiteCentric connects your regulatory and recruitment workflows so that every outreach campaign is reviewed, approved, and documented before it goes live. Safeguards and warnings flag anything that’s out of compliance.
Ad Approval & IRB Compliance Built In
Never risk running unapproved ads again. SiteCentric connects your regulatory and recruitment workflows so that every outreach campaign is reviewed, approved, and documented before it goes live. Safeguards and warnings flag anything that’s out of compliance.
Internal Quality Assurance Tools for Research Sites
Sponsors and CROs use QA tools to monitor your site—so why shouldn’t you? SiteCentric’s Quality Assurance module empowers your site with built-in tools to monitor visit quality, identify training gaps, and reduce protocol deviations. Make risk-based QA decisions and demonstrate your performance proactively.
Internal Quality Assurance Tools for Research Sites
Sponsors and CROs use QA tools to monitor your site—so why shouldn’t you? SiteCentric’s Quality Assurance module empowers your site with built-in tools to monitor visit quality, identify training gaps, and reduce protocol deviations. Make risk-based QA decisions and demonstrate your performance proactively.
Internal Quality Assurance Tools for Research Sites
Sponsors and CROs use QA tools to monitor your site—so why shouldn’t you? SiteCentric’s Quality Assurance module empowers your site with built-in tools to monitor visit quality, identify training gaps, and reduce protocol deviations. Make risk-based QA decisions and demonstrate your performance proactively.
Track Provider Consistency
Consistency in visit conduct improves quality and reduces error rates. Our QA module helps you track which staff conducted which visits, uncover patterns, and flag areas where retraining or oversight may be needed.
Track Provider Consistency
Consistency in visit conduct improves quality and reduces error rates. Our QA module helps you track which staff conducted which visits, uncover patterns, and flag areas where retraining or oversight may be needed.
Track Provider Consistency
Consistency in visit conduct improves quality and reduces error rates. Our QA module helps you track which staff conducted which visits, uncover patterns, and flag areas where retraining or oversight may be needed.
Clinician Dashboards & Quality Alerts
SiteCentric brings QA front and center—clinicians can respond to findings directly from their dashboards without switching systems. Utilize collaborative modules to improve responsiveness and easily resolve queries.
Clinician Dashboards & Quality Alerts
SiteCentric brings QA front and center—clinicians can respond to findings directly from their dashboards without switching systems. Utilize collaborative modules to improve responsiveness and easily resolve queries.
Clinician Dashboards & Quality Alerts
SiteCentric brings QA front and center—clinicians can respond to findings directly from their dashboards without switching systems. Utilize collaborative modules to improve responsiveness and easily resolve queries.
Smart Paper Archives Management
Going paperless is the goal—but paper still happens. SiteCentric’s barcode-driven Archive Management lets you track the location of paper records, both on-site and off-site, and automate retention and destruction dates to reduce costs and simplify audits.
Smart Paper Archives Management
Going paperless is the goal—but paper still happens. SiteCentric’s barcode-driven Archive Management lets you track the location of paper records, both on-site and off-site, and automate retention and destruction dates to reduce costs and simplify audits.
Smart Paper Archives Management
Going paperless is the goal—but paper still happens. SiteCentric’s barcode-driven Archive Management lets you track the location of paper records, both on-site and off-site, and automate retention and destruction dates to reduce costs and simplify audits.
Built-In Training Oversight
Identify who’s trained and who’s not—without digging through binders. Our Training Manager integrates with your regulatory workflows so you can assign, track, and store certificates for GCP, protocol, and procedure-specific training.
Built-In Training Oversight
Identify who’s trained and who’s not—without digging through binders. Our Training Manager integrates with your regulatory workflows so you can assign, track, and store certificates for GCP, protocol, and procedure-specific training.
Built-In Training Oversight
Identify who’s trained and who’s not—without digging through binders. Our Training Manager integrates with your regulatory workflows so you can assign, track, and store certificates for GCP, protocol, and procedure-specific training.
The system of checks and balances built into this platform will enable a site to be audit ready at all times! Also, the reduction in protocol deviations will be invaluable as a quality assurance tool.
Joan Cutillo, CRA II Premier Research
The system of checks and balances built into this platform will enable a site to be audit ready at all times! Also, the reduction in protocol deviations will be invaluable as a quality assurance tool.
Joan Cutillo, CRA II Premier Research
The system of checks and balances built into this platform will enable a site to be audit ready at all times! Also, the reduction in protocol deviations will be invaluable as a quality assurance tool.
Joan Cutillo, CRA II Premier Research
FAQ's
Frequently asked questions on Regulatory Compliance
FAQ's
Frequently asked questions on Regulatory Compliance
FAQ's
Frequently asked questions on Regulatory Compliance
How does SiteCentric simplify regulatory document management?
Our eISF provides an organized, digital environment where you can store, track, and share study documents. Features like “Mark Reviewed,” expiration alerts, and remote monitor access streamline compliance workflows and keep your site inspection-ready.
How does SiteCentric simplify regulatory document management?
Our eISF provides an organized, digital environment where you can store, track, and share study documents. Features like “Mark Reviewed,” expiration alerts, and remote monitor access streamline compliance workflows and keep your site inspection-ready.
How does SiteCentric simplify regulatory document management?
Our eISF provides an organized, digital environment where you can store, track, and share study documents. Features like “Mark Reviewed,” expiration alerts, and remote monitor access streamline compliance workflows and keep your site inspection-ready.
Can SiteCentric help us avoid protocol deviations?
Yes! Our QA tools help you track provider performance and query resolutions, identify training gaps, and ensure procedural consistency. These insights allow your team to take corrective actions early and maintain GCP compliance.
Can SiteCentric help us avoid protocol deviations?
Yes! Our QA tools help you track provider performance and query resolutions, identify training gaps, and ensure procedural consistency. These insights allow your team to take corrective actions early and maintain GCP compliance.
Can SiteCentric help us avoid protocol deviations?
Yes! Our QA tools help you track provider performance and query resolutions, identify training gaps, and ensure procedural consistency. These insights allow your team to take corrective actions early and maintain GCP compliance.
How are IRB ad approvals managed?
Ads submitted through the recruitment module flow directly to the regulatory team for review and approval. The system prevents ads from being scheduled or used until approvals are in place, reducing the risk of non-compliance.
How are IRB ad approvals managed?
Ads submitted through the recruitment module flow directly to the regulatory team for review and approval. The system prevents ads from being scheduled or used until approvals are in place, reducing the risk of non-compliance.
How are IRB ad approvals managed?
Ads submitted through the recruitment module flow directly to the regulatory team for review and approval. The system prevents ads from being scheduled or used until approvals are in place, reducing the risk of non-compliance.
Can I track which staff are qualified to perform specific study procedures?
Absolutely. SiteCentric’s integrated Training Manager lets you assign study-specific tasks and quickly confirm who is trained for each one. It’s all tied into the eISF and QA systems for full visibility.
Can I track which staff are qualified to perform specific study procedures?
Absolutely. SiteCentric’s integrated Training Manager lets you assign study-specific tasks and quickly confirm who is trained for each one. It’s all tied into the eISF and QA systems for full visibility.
Can I track which staff are qualified to perform specific study procedures?
Absolutely. SiteCentric’s integrated Training Manager lets you assign study-specific tasks and quickly confirm who is trained for each one. It’s all tied into the eISF and QA systems for full visibility.
What about paper documents—can I manage those in SiteCentric too?
Yes! Our Archive Management tool lets you barcode and track the location of all paper documents, automate destruction timelines, and reduce storage costs—whether records are on-site or off-site.
What about paper documents—can I manage those in SiteCentric too?
Yes! Our Archive Management tool lets you barcode and track the location of all paper documents, automate destruction timelines, and reduce storage costs—whether records are on-site or off-site.
What about paper documents—can I manage those in SiteCentric too?
Yes! Our Archive Management tool lets you barcode and track the location of all paper documents, automate destruction timelines, and reduce storage costs—whether records are on-site or off-site.
How does QA integrate with the rest of the CTMS?
QA in SiteCentric isn’t a bolt-on—it’s deeply connected. From the moment a visit is completed, QA tools evaluate the data, notify teams, and allow corrective actions—all within the same platform your team already uses for scheduling, source, and billing.
How does QA integrate with the rest of the CTMS?
QA in SiteCentric isn’t a bolt-on—it’s deeply connected. From the moment a visit is completed, QA tools evaluate the data, notify teams, and allow corrective actions—all within the same platform your team already uses for scheduling, source, and billing.
How does QA integrate with the rest of the CTMS?
QA in SiteCentric isn’t a bolt-on—it’s deeply connected. From the moment a visit is completed, QA tools evaluate the data, notify teams, and allow corrective actions—all within the same platform your team already uses for scheduling, source, and billing.
See how every module works together to elevate your site
See how every module works together to elevate your site
See how every module works together to elevate your site
All Rights Reserved © 2025 SiteCentric.
SiteCentric, SiteCentric CTMS, and SiteCentric Clinical Trial Management Software and affiliated logos are registered trademarks owned by Clinical Neuroscience Solutions, Inc. d/b/a SiteCentric.
All other trademarks, names, and logos referenced on the SiteCentric website are the property of their respective owners. Any use of third-party trademarks is for identification and informational purposes only and does not imply any affiliation, endorsement, or sponsorship by those third parties.
All Rights Reserved © 2025 SiteCentric.
SiteCentric, SiteCentric CTMS, and SiteCentric Clinical Trial Management Software and affiliated logos are registered trademarks owned by Clinical Neuroscience Solutions, Inc. d/b/a SiteCentric.
All other trademarks, names, and logos referenced on the SiteCentric website are the property of their respective owners. Any use of third-party trademarks is for identification and informational purposes only and does not imply any affiliation, endorsement, or sponsorship by those third parties.
All Rights Reserved © 2025 SiteCentric.
SiteCentric, SiteCentric CTMS, and SiteCentric Clinical Trial Management Software and affiliated logos are registered trademarks owned by Clinical Neuroscience Solutions, Inc. d/b/a SiteCentric.
All other trademarks, names, and logos referenced on the SiteCentric website are the property of their respective owners. Any use of third-party trademarks is for identification and informational purposes only and does not imply any affiliation, endorsement, or sponsorship by those third parties.