6th Clinical Trials Inspection Readiness Summit – 6th Clinical Trials Inspection Readiness Summit

As clinical trials are conducted, inspections ensure quality and integrity of care, data and drug performance. As sponsors for clinical trials, pharmaceutical companies are required to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections are conducted by regulatory authorities, which all have unique regulations and caveats. These nuances make inspection readiness a difficult and resource-consuming battle. Clinical trials must be prepared for visits from countless stakeholders over their course.

In our research, we at ExL have found that, within the pharmaceutical industry, organizational culture should prioritize inspection readiness as a major part of clinical trial success. Unfavorable inspection findings will cause issues that could delay trials or even shut down drug development. Concentrating on more areas of inspection readiness — such as metrics, data integrity and technology — can guarantee these findings are never a surprise.

At the 6th Clinical Trials Inspection Readiness Summit, you will understand the importance of an organizational culture of inspection readiness and how to implement that cultural change. With two days of advanced sessions, roundtables and case studies about effective documentation standards, the culture of preparedness and improved stakeholder engagement, you will shift your organization to a quality-first, quality-always culture.

Top Five Reasons to Attend

  1. Use different perspectives on inspection readiness to improve clinical operations and guarantee success
  2. Promote and ensure compliance with all regulatory agencies and their regulations using new systems and innovative methodologies
  3. Ensure trials are organized with improved oversight and communication to protect study participants’ rights, safety and welfare
  4. Foster the intelligent design of clinical trial inspection readiness procedures by identifying trends that improve and encourage inspection readiness from past inspection metrics
  5. Assure quality and compliance are paramount, and convert inspection readiness from a singular activity to an organizational culture for successful clinical trials

Who Should Attend

This conference is designed for professionals from academia and pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:

  • Quality Assurance/Quality Control
  • Quality Compliance/Quality Management
  • Clinical Operations/Research/Planning
  • Outsourcing/Development
  • Records/Data Management
  • R&D Operations
  • Clinical Trials Management
  • Global Compliance
  • Risk-Based/Centralized Monitoring
  • Clinical Research
  • Safety and Risk Management Operations
  • Internal/External Auditing
  • Clinical Project Management
  • Trial Master Files
  • Clinical Documentation
  • Clinical Site Management
  • Global Regulatory Affairs
  • CAPA Auditing
  • Adverse Event Management
  • Metrics and Benchmarks
  • Process Optimization
  • Site Performance Management

The conference may also be of interest to the following:

  • CROs
  • Inspection Readiness Software Providers
  • Data/Records/Archive Management Vendors
  • TMF Vendors
  • Quality Management Service Providers
  • Electronic Signature Companies
  • Readiness Consultants