Inspection Readiness Elevated
Ensure your clinical trials are compliant and inspection ready with our Inspection Readiness expertise. From TMF Audits & Remediation, Sponsor Oversight Evaluation to Mock Inspections, we offer a comprehensive tailored approach for your needs.
Helping Smaller Organizations Achieve Inspection Readiness
While the most successful organizations maintain a constant state of inspection readiness, smaller organizations often struggle to do the same. The fast-paced nature of their operations can lead to overlooked processes, increasing the risk of non-compliance
Our success is your success
We pride ourselves on our adaptability and commitment to excellence in every aspect of our service. Explore what we have to offer and how we can contribute to your success.
Services
Assessment & Gap Analysis
Evaulation of current processes to identify potential gaps that may be highlighted during an inspection.
Development and Implementation of Remediation Plans
Creation of SOPs, Plans and templates to address gaps identified and process improvement.
Training
Provide training on inspecetion readiness,GCP and Sponsor Oversight
Mock Inspections
Simulate actual inspections for both Sponsors and sites
FAILED INSPECTIONS CAN COST $200MM OR MORE IN OPPORTUNITY COSTS AND DIRECT COSTS ASSOCIATED WITH REMEDIATION
*Boston Scientific Resolves FDA Warning Letter, Wall Street Journal, August 11, 2010
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Benjamin Wood
"I can't say enough about the outstanding service I received from your company. Their team went above and beyond to meet our needs and exceeded our expectations."
Emma Thompson
"I can't say enough about the outstanding service I received from your company. Their team went above and beyond to meet our needs and exceeded our expectations."
Oliver Hartman