Resources

Compliance and Regulatory

Getting the Most from Your Integrated Site Solutions

Integrated research systems can help streamline your operations, centralize workflows and reduce effort across your teams. But choosing your technology providers can have a big impact on long-term success at your organization.

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Building Processes and Procedures to Ensure Your Site is Audit-Ready

In this webinar, Stuart Cotter, Forte’s Director of Product Success and former Forte eReg Product Manager, and MaryAnn Kempker, Forte’s Computer System Validation Project Manager, provide insight into how your site can proactively plan for audits and monitoring visits.

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How to Build a Successful and Sustainable Coverage Analysis Team

Having a team of coverage analysts to ensure compliant clinical trial financial management can be invaluable. Learn what to look for in your coverage analysts and how to build a successful team.

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Using Integrated CTMS and eReg Systems to Build New Clinical Research Efficiencies

Learn how an eRegulatory-CTMS integration can improve workflows and bring additional benefits to your institutional research operations.

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Trial Data Exchange: A Site-Centric Approach to Standardizing Regulatory Management

The Trial Data Exchange will build a two-sided network, allowing sites and sponsors can easily access and share standardized clinical research data, including critical regulatory documents.

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Key Considerations for Regulatory Compliant Document Storage

The criteria covered in 21 CFR Part 11 are not the only requirements that should be considered for compliant document management associated with clinical trials.

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[Q&A] Understand the Key Roles for Effective CCSG Management

Our expert webinar presenter answers attendee questions about internal communication plans for effective CCSG management, changes to the how the NCI views cancer centers, and more.

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How Your Organization Can Utilize a Research-Specific Disaster Plan

As natural and man-made disasters have become more prevalent in the healthcare industry, it’s important for research organizations to ensure they have well-defined business continuity and disaster recovery plans.

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How Your Approach to Regulatory Management Can Affect Disaster Recovery Readiness

Whether using paper, shared drive or vendor-provided systems to manage regulatory documents, research organizations need to ensure their data is safe in the event of a natural disaster.

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[Q&A] Understanding, Achieving and Maintaining 21 CFR Part 11 Compliance

Expert webinar presenters answer attendee questions about 21 CFR Part 11 compliance and the validation process for electronic systems.

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