Project Management and Regulatory Services

Effective Project Managers are essential for managing the study team and meeting project time-lines.  Clinique Research Services, Inc. provides full project management support by assigning a Clinical Project Manger to communicate and manage all study activities.  There are 75% of Clinique Research Services, Inc. consultants which have project management experience from previously held industry positions.

Clinical Research Project Manager Tasks:

• Contract Negotiation

Clinique Research Services Inc. provides complete contract negotiation, that include but are not limited to; site negotiation, payment for services & consulting outsourcing for the conduct of clinical trials.

• Contract Management

Clinique Research Services, Inc. provides tracking, oversight and execution of contract/grant payments to clinical research sites and outside consultants.

• Outsourcing Management

Clinique Research Services, Inc. will maintain and execute oversight and management of contractors including CRO’s, central laboratories and independent consultants.

• Timeline Tracking

Clinique Research Services, Inc. will identify and assist clients in establishing and maintaining study milestones and deadlines throughout the conduct of the clinical trial.

• Trip Report Review and Submission

Clinique Research Services, Inc. will collect, review and submit monitoring visit documentation and assume the responsibility for submission to the client.

• Quality Assurance Program

Clinique Research Services, Inc. has designed and implemented a proprietary “Monitor the Monitor” program. Clinical Research Project Managers audit previously monitored research to ensure quality monitoring and adherence to company standard operating procedures.

Regulatory Services

  • Regulatory submissions to Ministry of Health and Ethics committee for Clinical Trial Approval.
  • Inspection readiness preparing the site or sponsor for regulatory inspections

 

 
 
Sidebar