Clinical Operations
Our FSP Models are tailored to accommodate any clinical operations service or function. Whether supplying individual resources, small teams, or large outsourcing initiatives, you have the flexibility to choose to outsource in a targeted way to suit your budget and timelines.
- Monitoring
- Study Management
- TMF Management and Maintenance
- Project Support
Clinical Operations and How We Achieve Success
From project/study management to monitoring activities that align to your company's vision and culture, understanding our clients’ successes and individual challenges is pivotal to configure roles and responsibilities with the goal of optimizing timely deliverables.
Our Areas of Expertise
Our core competencies within Clinical Operations include:
Clinical Research Associates (CRAs)
Clinical Trial & Study Management (Including CRO Oversight)
Study Startup & Site Feasibility
Clinical Compliance (Including Audit Readiness and Pre-Submission Documentation Internal Training and SOPs)
Clinical Portfolio & Project Management
Clinical Systems, Applications & Tools
Clinical Trial Management Systems (CTMS), Implementation & Adoption (Including Veeva Vault)
Therapeutic Area (TA) Subject Matter Experts (Including Study Physicians, Scientists, Medical Monitors, and Principal & Reliability Engineers)
Benefits of an Eliassen FSP Partnership
Building on over 20 years of FSP experience, we offer quality resources and a white glove client service, based on the guiding principles of partnership, individual attention and trust. We will work with you and your teams to find the best solution and will stay close to your objectives, anticipating your needs as your pipelines and focuses grow and change.
Cost Efficiencies
We offer multi-year pricing models, providing predictable budgeting in line with forecasts and cost savings from solution planning upfront.Tailored Delivery Model
We use a highly competent experience-driven operational approach driven by total flexibility, to provide truly customized support with optimal line management infrastructure and oversight, turnover and training, managed by the FSP team.Dedicated Resources
Work with fully dedicated resources, managed by us and fully integrated within the client team. In this model, your core in-house team is free to focus on their role and strategy, improving productivity, quality and reducing pressure.Reduced Timelines
We provide seasoned expert resources with a solution-focused mindset and unrivalled expertise to provide geographic coverage where it may not already exist, maximize efficiencies, and reduce timelines.Ability to Plan for Resourcing Needs
We know each project is different with unique challenges and requirements. We collaborate with your teams to optimize your resourcing needs, project pathway, mitigate risk, minimize complexity and maintain budgets.Utilize Your SOPs
An FSP model results in reduction in risk and duplicate efforts by leveraging client systems and SOPs.
Deep Functional Expertise
Our focus is exclusively on attracting and retaining world-class talent and delivering best-in-class FSP solutions that fit clients' unique needs through our deep functional expertise.
Increased Quality & Control
FSP provides you control over the extent of your outsourcing, allowing you to maintain oversight, better manage studies and ensure quality.
A Record of Success
Learn more about our past success in business optimization and program management.