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Will You Be Ready When Inspectors Show Up at Your Door?
Establishing a Trial Master File plan and audit schedule are vital to the success of every clinical trial. Waiting until the 11th hour will compromise your ability to ensure that your documentation fully complies and is ready for inspection.
Clinical Research Strategies has the know-how and game plan to maintain regulatory and essential records and reduce the failures often seen in waiting until the last minute. Our planning and maintenance in accordance with industry standards takes most of the worry out of inspection-readiness. Our highly trained dedicated team combines sponsor-side and CRO expertise:
- Clinical Research Operations, Quality Assurance, and Regulatory Affairs within CROs, start-ups, and large
medical device and pharmaceutical companies
- Regulatory and Essential Document Requirements for Inspection-Readiness
- TMF planning, rescue, and remediation
- DIA TMF Reference Model and abbreviated device models
- TMF software neutral
- Customized SOPs and TMF Plan
- Nimble. Hands-on Knowledge. Auditors. Advisors. Trust.
Let’s get to work now before it’s too late. Contact us today.
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Founded in 2011.