Resources

Compliance and Regulatory

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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Understanding, Achieving and Maintaining 21 CFR Part 11 Compliance

Watch this webinar to hear our expert presenters provide an overview of 21 CFR Part 11 and discuss the roles both organizations and vendors play during the validation process.

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Forte’s Approach to Development: 21 CFR Part 11 Compliance

Forte’s development approach is to not only navigate industry regulations, but to strategize how to best serve and assist our community. Learn Forte’s philosophy towards developing 21 CFR Part 11 compliant systems.

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