Clinical Quality Assurance 

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• For-cause & due-diligence investigator site audits

• Vendor audits

• Regulatory audits

• System and process Audits

• Inspection readiness

• Quality event management/CAPA

• Oversight and management of document Control​

• Regulatory training

Clinical Operations

• Remote and on-site monitoring

• Risk based monitoring

• ​Site identification and qualification visits

• Trial master file (TMF) Management

• Clinical site management

• Site relationship

• Identifying and mitigation risks

• identifying and managing safety issues

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Global Project Management

• Global and regional project management

• Study feasibility

• Vendor oversight and management

• Risk management

• ​Study start-up

• Project specific training

• Biologic sample handling

• Budget management

• Accelerating site activation

• Clinical trial application

Clinical QMS Consulting Services

• QMS assessment

• Policy and procedure development

• End-to-end QMS implementation

• QMS training & readiness