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Clinical Regulations

BEST IN CLASS PRACTICES

End-to-End Compliance

The Compliance Insight network of Clinical FDA Regulation specialists offers broad support and nuanced expertise in designing and improving clinical development and operation practices. Our associates perform audits of existing processes and systems, and develop customized, evidence-based approaches to implementing best in class standard operating procedures (SOPs) to ensure that they are compliant with Clinical FDA Regulations.

 

Our associates ensure you have the Good Clinical Practice (GCP) systems you need, and help you institute the kind of foundational operations that will contribute to your growth and success.

Select Services & Capabilities

  • Clinical Quality System Design & Implementation

  • Clinical Quality Manuals

  • SOPs

  • CAPA design

  • Risk Management

  • Vendor & Site Audits

  • Ongoing Trial Audits

  • Clinical Project Management

  • Clinical Monitoring

  • Clinical Operations

  • Staff Augmentation

  • Team Management

  • Training

  • Strategic Planning

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