GCP Inspection Readiness

Pre-Inspection Preparation:

Comprehensive Assessment:

We conduct a thorough assessment of your clinical trial processes, documentation, and quality systems to identify areas that require attention. Our experts evaluate your compliance with GCP regulations and provide recommendations for improvement.

Gap Analysis and Corrective Action Plans:

ERA performs gap analyses to identify deficiencies in your GCP compliance. We assist in developing corrective action plans to address identified gaps and ensure compliance.

Documentation and Recordkeeping:

Documentation Review:

Our team reviews and assesses your clinical trial documentation, ensuring that it is complete, accurate, and organized in accordance with current GCP standards.

ERA can help you maintain a comprehensive and well-organized Trial Master File (TMF).

Training and Education:

We offer training and education programs to enhance the GCP awareness and competence of your clinical trial personnel. ERA ensures that your team is well-prepared for regulatory inspections.

Mock Inspections and Drills:

Mock Inspections:

ERA conducts mock GCP inspections to simulate real inspection scenarios.

We evaluate your organization’s response to potential inspection findings and provide feedback for improvement.

Inspection Preparedness Drills:

Our experts lead inspection preparedness drills to ensure that your team is well-prepared to handle actual inspections. ERA helps you refine your processes and responses.

Inspection Attendance and Responses:

Expert Attendance:

In the event of a regulatory inspection, ERA provides expert attendance to support your organization during the inspection process.

We serve as your liaison with regulatory authorities and ensure effective communication.

Response Management:

Our team assists in drafting and submitting timely and comprehensive responses to inspection findings. ERA helps you address any regulatory concerns and implement corrective actions.

By partnering with ERA for GCP inspection readiness, you gain a dedicated ally in maintaining the highest standards of clinical trial compliance. Our commitment to thorough preparation, documentation excellence and effective response management ensures that your organization is well-equipped to handle GCP inspections and maintain the integrity of your clinical research.