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Clinical Data Science

High quality data to enable better informed decision making

High quality data to enable stronger and more informed decision making

Fast delivery of high quality and meaningful data means that you can make well informed decisions earlier in the trial. This also ensures patient protection and reliable trial results.

Sponsors rely on us for flexibility, quality, and technical expertise in our customised, cost-effective solutions. Our multidisciplinary team of industry experts offer consulting along with standalone and full-service integrated solutions focused on project success and in line with your study goals.

  • 1,000+

    Global professionals

  • 1,300+

    EDC studies completed

  • 75%

    Reduction in resource costs

Our approach starts with the end in mind, tracking backward along the regulatory pathway to ensure the data is reported, displayed, captured and fully compliant with global data and reporting requirements.  Effective communication and accountability ensure your projects stay on track, on time, and within budget.

Areas of expertise

  • Portfolio management
  • Biostatistics & programming
  • Data operations
  • Standards
  • Clinical systems management

Our propriety technology and innovative delivery platforms automate tasks that have traditionally involved manually writing and validating programs. These comprehensive and flexible systems replace outdated, manually programmed processes with automated, reusable programs for data extraction, data transformation, statistical reporting and electronic publishing, resulting in significant process savings, streamlined documentation, and improved quality.

Electronic data capture (EDC) database build

We get our electronic data capture (EDC) build is completed quickly and effectively, supporting the study team to meet early critical milestones.

The full process from final protocol to a live EDC will take place within eight weeks. Associated validation checks are completed to ensure the highest quality deliverables, supported with:

  • Rigorous control and deployment of standards
  • Streamlined review and approval process
  • Interactive online review meetings and UAT 

We are an industry leader in the management of EDC studies and have full EDC build capabilities in all key systems including:

  • Veeva Vault CDMS™
  • InForm™
  • Medidata for Rave™
  • ClinInfo

Day database lock target of 21 days 

Early planning with cross functional teams enables us to achieve database lock within a 21-day timeframe. We provide ongoing data review, along with efficient reconciliation of external data. 

Identifying site trends and implementing risk mitigation strategies enables us to keep processes on track. Study unlocks are kept to a minimum with metrics indicating under 3% after database lock.

Integrating data for improved efficiency

We are able to consolidate our data with external vendor data including; Laboratories, ECG, Safety, ePRO, and IxRS.  Integrate of data removes the need for multiple platforms.

Cost competitive pricing

Leveraging our global capabilities, cross functional collaboration and creating standard data structures, we can offer you maximum cost efficiency and shorter development timelines.

Applied innovation

As a comprehensive solution, ICON has implemented Clinical Data Studio to enhance efficiencies and accelerate clinical discovery across diverse cross-functional teams. The platform unifies data from multiple sources, streamlining processes through automation and delivering real-time, actionable insights. 

Clinical Data Studio supports a wide range of use cases, including clinical data science, central monitoring, clinical operations, medical monitoring, clinical programming, and other critical data-driven functions. By automating repetitive tasks and integrating disparate data sources, Clinical Data Studio empowers teams with greater agility, improved data quality, and enhanced decision-making capabilities.

Experience you can trust

One of the key drivers of success in your study is to have an experienced team. We are Platinum CDISC members, and have field leading expertise in SDTM and legacy data conversion. Over 120 members of our staff are trained in SDTM implementation.

Scalable and fully customisable models

ICON is a trusted, market-leading partner to pharmaceutical, biotech and medical device organisations of all sizes. We are dedicated to helping sponsors implement, manage, and optimise high-performing functional teams.

Our leadership approach provides bespoke oversight of clinical data science activities, ensuring our clients’ projects run seamlessly. By driving team performance and guaranteeing consistent, successful delivery, we empower sponsors to achieve their trial goals with confidence and precision.

We offer a wide range of customisable operating models to meet your needs, whether using ICON systems, sponsor systems, or a hybrid approach. Services can be delivered as consulting, standalone, FSP, blended or full service and across all therapeutic areas.

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Case studies: Clinical Data Science

Explore our library of clinical data science case studies to find out how we have increased operating efficiencies for our clients.

Explore our case studies
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