Project/CRO Management
Project Management and Outsourcing Management
Co-ordinating the various processes from one phase to another, meeting timelines and dealing with complex regulations are often a challenge during the drug discovery and drug development processes. CapEval consultants have in-depth project managment experience gained through a multitude of studies and integrated projects, allowing us to negotiate activities, foresee critical-path events and prepare clients for the challenges facing them as they advance to the next milestone. By working closely with our clients to understand needs, timelines and budgets, we can remove some of the pressures our clients face and build a smooth drug development program ultimately achieving project deliverables faster, meeting all standards for quality and regulations and minimizing costs.
CapEval consultants have expertise in project management and outsourcing management and we can manage a range and diverse set of development programs for our clients. The scope and breadth of help can be tailored based on the needs and demands of the program and we can manage and control the various steps within the life cycle of your project from initiation, through planning and execution to completion.
Our consultants can work on your behalf in the following capacity:
Identify and inititate contact with external partners who have the right skill set and knowledge to achieve project deliverables
Draft request for proposals for out-sourced work, develop technical packages for transfer of information, and lead or participate in preliminary meetings to develop a quotation which best suits the needs of the project
Act as a primary point of contact for outsourced projects
Review , and MSAs
Develop and draft sound quality agreements
Identify project risks at the onset of the program
Devise back-up and contingency plans
Resolve technical and quality issues
Manage scope changes and resource allocations
Ensure transparancy, flow of information and communication
Ensure the project team maintaines focus on agreed-upon objectives
Monitor the progression of the project and ensure objectives and deliverables are met
Timely and cost effectively Project Management from Lead identification to Market according to regulatory requirements in the following fields:
Drugs and medical devices
NCE’s
Biomolecules
Vaccines
Medical devices
Diagnostic tools
Animal health care
Cosmetics
Agrochemicals
Pesticides