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 Managment
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.
Supporting your program with experienced leadership level roles.
Evaluation of Clinical Readiness
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.
Understanding your program timelines vs. reality.
Regulatory & Quality Assurance
Alignment with Regulatory requirements for development and clinical as well as Quality considerations that are stage appropriate.
Key areas of the industry that can't be overlooked.
Investigators & KOLs
Creating transparent and solid relationships with Investigators to further drive the research, whilst balancing expectations and contributions from Key Opinion Leaders.
Key relationships in a program with the right level of attention and focus.
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.
All the pieces that make a program a progam move.
Strategic Reporting & Forecasts
A key aspect for your company's Board of Directors and Investors decision making processes, based on performance, forecasts and milestones.
Provides the essential information needed for all levels of stakeholders.
Representing Your Interests
Save on headcount costs while having an experienced resource in your team, supporting your program with a Head of Operations level representative or Subject Matter Expert.
A valuable resource that is an integrated part of your team.