Clinical Project Management
Our business success hinges on our outstanding Project Management strategies. Success starts by simply meeting face-to-face. Our highly qualified team of experts will take the time to acquire a proficient understanding of your company, clinical project, goals and timelines, molding our expertise to your needs. We will work with you to find the right combination of professional services based on our extensive experience, current knowledge, and our joint future vision.
Our Project Management Team provides critical leadership across the project team. We will work with you to complete the deliverables and strive to meet your project timelines. We will support your project with seamless communication that will define and guide your project.
We are committed to meeting your company’s needs for quality, compliance, and agreed upon delivery times in order to achieve and, where possible, exceed the target plan with the guarantee that all work is carried out in accordance with SOPs, GCP/ICH guidelines and FDA/EMEA regulatory requirements.
Project Management Core Services:
- Provide Leadership for High Performance Support Teams
- “Hands-On” Oversight From Concept To Completion
- Coordinate Critical Tasks of Cross-Functional Project Teams
- Prepare Clinical Project Deliverables; Protocols, CRFs, CRS, Clinical Study Tools
- Identify Qualified PIs and Prepare Investigational Site Lists
- Participate in Reviewing and Approving Investigational Sites
- Planning of Investigator Meetings
- Development and Achievement of Project Milestones
- Support of Accurate Enrollment Forecasting And Enrollment
- Study Budget Forecasting and Contract Negotiation
- Development of Contingency Plans
- Development of Risk Analysis and Outsource Plans
- Preparation of Critical Path Analysis