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Clinical Study Strategy, Planning and Operations
ENEM Consulting provides clinical, and quality systems support to help ensure engineering and clinical deliverables align with regulatory strategy.
Our Services include:
Clinical Site Audits
Auditing of clinical study sites toward preparation for FDA BIMO audits, includes:
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Contract Research Organization (CRO) Audits
Conducted on behalf of the sponsor, the audits help ensure that the CRO is in compliance with Good Clinical Practice (GCP) regulations and will include:
GLP Audits
Conducted on behalf of the sponsor, the audits help ensure that the test laboratory is in compliance with Good Laboratory Practice (GLP) regulations and will include:
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Quality Systems Support
Quality Systems development to FDA QSR and ISO 13485 regulations including:
Pre-clinical Test Planning
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Training
Training to FDA QSR, design control requirements
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Supplier Audits
Assessing the manufacturing processes associated with components including: