Europe, Middle East & Africa
Add capability without adding capital investment.
The Functional Service Provider (FSP) model at IQVIA optimizes clinical development by delivering a flexible mix of functional expertise, resource management, and technology-enabled solutions to maximize your global programs.
Work faster, smarter and more efficiently
IQVIA functional services fills gaps and manages workflows with customized offerings to support a broad range of needs, including clinical data management, safety, regulatory, clinical monitoring, and biostatistics.
Specialized services, from statistical programming and medical writing, to deploying connected devices and the latest in advanced analytics, ensure the right resources are used at the right time. Benefits include
- Cost-effective solutions that leverage low-cost geographies
- Enhanced performance and safety
- Resource, productivity or outcome-based solutions to meet efficiency goals
- Scalable and flexible models for diverse sizes and complexities
Our Models Include:
- Staff Augmentation – providing on demand on/offsite resources to fit your time frames.
- Managed Staffing – in addition to staff augmentation benefit from direct line of management and functional oversight
- FSP Outsourcing – further your partnership with IQVIA with a longer term FSP offering make us the sole service provide and transferring responsibilities towards us.
- FSP Advance – delivering value and efficiencies beyond traditional FSP resourcing with our innovative and adaptable model with coordinated integration of services and cutting edge transformative technologies and unparalleled data insight
- FSP Hybrid – Access our full service non-dedicated expertise, plus transfer your processes, control and risk to IQVIA.
Clinical Monitoring
From resource management to centralized monitoring
Whether you require resource management or a strategic outsourced centralized monitoring program, IQVIA’s clinical FSP programs provide a flexible mix of clinical monitoring expertise, resource management and technology-enabled solutions, each designed to deliver the results you need across your portfolio.
Our industry-leading centralized monitoring approach leverages IQVIA's global resource, real world data and advanced technologies to
- Enhance patient safety
- Improve data quality
- Help CRAs be more efficient through mobile capabilities and connected devices for faster data input and issue resolution
Learn more about Clinical Monitoring.
Pharmacovigilance
Manage safety across the product lifecycle
IQVIA is using automation to create efficiencies – and reduce costs – for adverse event identification and reporting, translations, case processing and more. All backed by unparalleled global data, analytics and more than a dozen years of global FSP delivery excellence.
Depending on your organizational needs, IQVIA can deliver safety case processing, operational expertise or fully integrated safety services, processes and technologies.
Learn more about Pharmacovigilance.
Regulatory
Stay a step ahead of change
Bring transparency, efficiency and predictability to your regulatory affairs strategy. IQVIA's flexible FSP programs let you outsource specific regulatory resources or configure fully integrated solutions.
A proprietary Regulatory Information Management (RIM) solution - IQVIA RIM Smart - powered by a centralized regulatory intelligence database and Business Process Management (BPM) tools support compliance and increase value for your product.
And with IQVIA's team of global regulatory scientists behind it all, you can manage regulatory challenges on a global scale, including
- Submitting multi-layered new drug applications (NDAs) and marketing authorization applications (MAAs)
- Executing label changes across several countries
- Staying ahead of the ever-changing regulatory needs
Learn more about Regulatory.
70+ countries
with customized FSP teams
Data Management
The value of data, beyond the numbers
From building your database to locking it down, IQVIA's FSP resources provide customized, innovative data management solutions.
From full-time employee to outcomes-based projects, IQVIA's data management methods help you
- Engage patients
- Improve data transparency
- Ensure data quality
- Allow for early problem solving
- Reduce oversight time
And with interoperable, system agnostic platforms, you can adapt quickly to the changing clinical development landscape.
Learn more about Data Management.
Statistical Programming
Drive automation to reduce cycle times
Working from planning to outputs and reporting, our statistical programmers are experts in CDISC standards and provide the right level of expertise through a flexible and agile resourcing solution to ensure quality project deliverables.
Our experienced statistical programming teams are supported by experienced functional managers, allowing them to focus on high quality delivery of
- CDISC dataset production (SDTM and ADaM) & legacy study conversions
- Tables, listings and figures for clinical study reports
- Pooled datasets for submissions - ISS and ISE
- Analysis to support regulatory submissions and create submission-ready documents
- PK/PD analysis
- Key safety reporting
- Define.xml and reviewers’ guides
Biostatistics
Make analytics a competitive advantage
Navigate the complexities of study design to drive speed and flexibility - without compromising quality. We help you turn data into actionable insights, reducing costs and risks, while accelerating timelines and quality of submissions.
Our biostatisticians use the latest technology and analytics to support all phases of clinical trials from trial design to publications. Our diverse trial design experience includes observational, real world evidence, adaptive, and complex Phase I design.
Our teams help reduce oversight time and ensure insightful interpretation through efficient production/QC of statistical components including
- Protocol and CRF development leveraging modeling and simulations
- Adaptive trials using precision dosing
- Evidence collection including interim assessment and biomarker testing
- Statistical analysis plans, integrated analysis, regulatory submission support and representation
- Post-marketing manuscript support, real world evidence and competitive analysis
Learn more about Biostatistics.
Get an overview of IQVIA's full range of solutions to help you work more efficiently, standardize and improve controls across development stages and geographies.
Access non-identified patient data with IQVIA’s device-agnostic platform that can provide both real-time data and endpoints.
IQVIA FSP Advance integrates expert functional resourcing with clinical services and innovative technology solutions to increase quality and efficiency – within a clinical trial or across a global R&D portfolio.