Project Management & 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

