Clinical Data Sciences

Through our Clinical Data Sciences services, Eliassen Group is a premier provider of biostatistics, statistical programming, data-related consulting, and FSP services for phase I-IV clinical trials and post-marketing data analysis and reporting services. With a team of SAS-experienced programmers, biostatisticians, standards and subject matter experts, our dedicated staff has clinical domain expertise to provide quality services how and when clients need them.

Expertise and Support in Niche Areas

Our Clinical Data Sciences consulting services help pharmaceutical, biotechnology, and medical device companies navigate complex and highly regulated drug development processes. Managing roadblocks is easier than ever with the foresight that our experience provides.

Focused Data Sciences Support

Clinical Data Sciences stands out as the premier, go-to submission support partner with a strong talent pool, technical expertise and exceptional product knowledge.  We've supported over 40 major NDA and sNDA submissions in multiple therapeutic areas and indications over the last 15 years.  

We formulate precise solutions to support the full lifecycle from conception to market, including analysis, compliance, standardization, submissions, and more.

We rely on a strong knowledge of the clinical study protocols, including the design, data collection methods, and clinical endpoints pertaining to various indications and therapeutic areas to support our clients’ needs.

Focused Data Sciences Support

Our Areas of Expertise

Our core competencies within Clinical Data Sciences include:

Statistical Programming & Analysis
Biostatistics
CDISC Consulting & Data Standards Rescue Work
Outcomes / Real-World Data
PK/PD Modeling & Programming
Regulatory Submission Support (ISS/ISE, Pooled Analysis RA) Responses
Data Mapping
Independent Validation of Programming

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 focus areas grow and change.

Cost Efficiencies

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

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

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

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

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

Utilize Your SOPs

An FSP model results in reduction in risk and duplicate efforts by leveraging client systems and SOPs.

Deep Functional Expertise

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

Increased Quality & Control

FSP provides you control over the extent of your outsourcing, allowing you to maintain oversight, better manage studies and ensure quality.