Preclinical Project Management
The complexity of preclinical and CMC development is not always well understood and this under-appreciation all too often results in toxicology, formulation, and analytical problems rearing their ugly heads at the most inconvenient times. We have on hand the scientists and project teams who have expertise in all preclinical fields, Our project managers knit them together into a cohesive group that keeps a program on track.
We design and manage complete preclinical, CMC and product development programs for virtual biotech companies. We provide the expertise and infrastructure of a big pharma R&D group without their bureaucracy and overhead. Using our strategic planning system called PathfINDAr (Building a strategy to the IND and NDA) , we develop a complete IND enabling program. This expert systems provides our project managers with a strategic plan and a Gantt chart with durations and a budget for the entire IND programs. We then support the project manager and the project team with infrastructure and on-line file sharing services such as SharePoint that allows the team to quickly and effectively communicate with our sponsors and our vendors.
Tools and Deliverables:
- Integrated Project Plans, Timelines, Milestones and Scheduling
- Work Breakdown Structure (see example below)
- Network Diagram (Evaluate Critical Path and Sequencing)
- Gantt Charts for Scheduling
- Cost Management
- Value Analysis
- Activity Costing
- Budget Planning, Management and Control
- Scrutinize and negotiations of Contracts
- Net Present Value Analysis
- Communications
- Planning to provide sufficient, relevant, accurate and consistent information to all the various stakeholders throughout the life of the project
- Methods, Means and Frequencies
- Foster Trust and Respect
- Project Status and Progress Reports
- Status Meetings
- Steering Committees
- Conference Calls/Videoconference