Project Management &
Clinical Operations

PiCRC's combination of project management and clinical research expertise allows us to skillfully manage and execute Phase I – IV clinical project operations by providing guidance and tools for tracking documenting and managing transparent and objective decision making using PRO-Active ⁱd³ concept. This is a new age approach of project management and operations which will be done keeping the SOPs and your current work environs in focus, thus helping teams meet the compliance standards and hence quality.

PiCRC will implement the PRO-Active ⁱd³ approach by adapting the existing tools within your organization to help develop project management and operations management methodologies to help build objectivity and data-driven intelligence in day-to-day decision management. We will also help your teams understand how issue management differs from proactive risk management and mitigation method. Though issue management provides immediate gratification to those providing instant solutions, proactive risk management uses the same energy to use this intelligence using data points that will drive the teams to analyze the situation and prevent risks from turning into issues. They will learn to identify, assess and review the risks and build the risk management culture within the project and operations management.

PM & Clin Ops service breakdown:

• Clinical Development Strategy and Protocol Development

• Project Management and Operations (Clinical, Data) Plans

• Site and Investigator Selection and Qualification

• Investigator Contracting and Payments

• Ethics Committee Coordination and Management

• Vendor Qualification and Management

• Clinical Trial Master File Management

• Investigator Meetings

• Tracking Project Deliverable

• Risk Identification, Mitigation, and Risk Management Meetings

• Project Team Meetings

• Project Progress Reporting

• Project Financial Management

• Document Management

• Issues tracking and resolutions

• Quality management support