SERVICES

Project Management

Project Management

LSK Global PS coordinates a clinical study as a whole and leads the entire teams as requested by a client by contemplating the project management plan and establishing the schemes for detailed project management, timeline management, quality management, risk management, and vendor management. LSK Global PS is utilizing the CTMS and the eTMF system to manage clinical studies efficiently and proposes the strategies for proceeding projects based on its know-hows in managing various systems.

Accumulated Experiences and Know-hows

LSK Global PS manages clinical studies to make them completed successfully within the planned time and cost through overall supervision of the projects in a flawless manner by consolidating skills and know-hows accumulated in each area of expertise.

Project Management

Service Scope

Project management

  • Develop Project Management Plan(PMP)
  • Direct and manage work
  • Perform integrated change control
  • Optimize resource
  • Communication management
  • Monitor and control the project

Timeline management

  • Plan how the schedule will be managed
  • Define the activities
  • Sequence the activities
  • Estimate the activities duration
  • Develop the schedule
  • Monitor and control the schedule

Quality management

  • Incorporating the organizations quality policy regarding planning, managing and controlling project and product quality requirements in order to meet stakeholders objectives.
  • Define SOP list
  • Training management
  • Change control

Issue and escalation management

  • Issue occurrence reported or detected
  • Document issue
  • Triage issue to determine severity
  • Escalate the Issue
  • Further classify the severity of the Issue as needed
  • Determine RCA(Root Cause Analysis)
  • Decide on CAPA
  • Implement, document and communicate CAPA

Vendor management

  • RFI, due diligence, audit: preferred supplier
  • Develop specification and send out RFP
  • Receive and review vendor proposal
  • Award project to vender
  • Finalize contract and/or SOW/Quality agreement
  • Project kick off
  • Oversee and review