STUDY START-UP

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• Completing essential document templates 

• Managing essential document signatures

• Collecting and filing documents in the investigator site file,

• Meetings with sponsors/CROs to review study start-up activities and provide updates.

• Institutional Review Board (IRB) Submissions

STUDY CONDUCT

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• Completing/Updating essential document templates

• Managing essential document signatures

• Managing the investigator site file for inspection readiness

• Meeting with sponsors/CROs to resolve regulatory action items

• Communicating site regulatory updates to the sponsor/CRO

• Completing IRB Continuing Review Submissions

• Attending all regulatory inspections and audits

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STUDY CLOSE OUT
 

• Collecting final signatures on essential documents

• Completing end of study templates per sponsor and site request.

• IRB Close-Out Submissions

AD-HOC SERVICES

• Completing aging sponsor/CRO open action items

• ISF Spot Checks to ensure inspection readiness

• Site regulatory audit prep and live assistance.