DEVOPS
(Development Operations Management)
GLOBAL OPERATIONS & OVERSIGHT
Development Ops Management is a service to coordinate your program operations. It may include more than one trial, have multiple tasks and scope in countries and/or regions.
It is not a Project Management service, but it manages wider scope of operations to ensure smooth and cost-efficient study conduct.
OVERALL PROGRAM COORDINATION
Having insight and the right level of control to move operations forward to feed information which provides decision making power in terms of strategy and resources.
EVALUATION OF CLINICAL READINESS (ECR)
Essential evaluation of the Development Pathway and Timelines is the deciding factor for the future of any program. Creating a strategy that is aligned with not only the financial drivers but also the R&D drivers is the first step to success.
REGULATORY AND QUALITY ASSURANCE
Alignment with Regulatory requirements for development and clinical as well as Quality considerations that are stage appropriate.
KOL & INVESTIGATORS
Creating transparent and solid relationships with Investigators to further drive the research, whilst balancing expectations and contributions from Key Opinion Leaders.
COORDINATION OF KEY SUPPORT SERVICES
From CDMOs , preclinical laboratories and Bioanalytical services to Regulatory support services. Ensuring that contractual matters are logically in place and oversight of these key support operations is smooth.
REPORTING & STRATEGIC FORECASTING
A key aspect for your company's Board of Directors and Investors decision making processes, based on performance, forecasts and milestones.