Product/Service

Data Management

Source: ICON

Translational Medicine

ICON delivers high-quality, cost-effective solutions to ensure the successful management and delivery of clinical trial data.

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ICON delivers high-quality, cost-effective solutions to ensure the successful management and delivery of clinical trial data.

We lead the way in the use of the technologies and standards and our Data Managers are proficient in the use of a wide range of technologies including Electronic Data Capture (EDC), Oracle Clinical®, Clintrial™, FrameMaker™, E-diaries, Optical Scanning and workflow systems.

Our experience and understanding of Electronic Data Capture (EDC) processes and systems enables us to provide the optimum solution for each project. We offer a full range of EDC services that can be combined to meet virtually any need. Our expert certified resources work with customers internally and externally to ensure each trial is developed to the highest standards using the latest technologies available in the marketplace.

Our Data Managers are also trained in the use of the latest standards including CDISC. We employ these standards to enable efficient review, processing transmissions and submission of data to the regulatory authorities. We continue to build an impressive portfolio of experience is the use of the various CDISC models including SDTM and ADaM.

Our world-class data-management professionals help our clients maximise the value of their research investment by providing the following services.

  •     Flexible Project Management
  •     Standalone Services
  •     Reporting
  •     Database Set-up
  •     Data processing/delivery
  •     EDC
  •     Training

We provide flexible data solutions from very large to small studies across all therapeutic areas. Our services can also be provided at clients sites on request.

  •     PI – PIV/ registry
  •     Rescue projects
  •     SOP preparation
  •     Study programs

ICON provides reporting through a Web portal which enables our clients to access CRF images as they are scanned in real-time. The system acts a repository for study documentation and also provides access to status reports.

As part of our Data Management service we facilitate the following meetings:

  •     Blind review
  •     CRA
  •     Investigator
  •     Lessons-learned
  •     Quality review

Our Data Management team have a standard library of CRF modules (in paper and EDC). We have vast experience of implementing client standards, integrating questionnaires and diary cards. We provide medical & statistical review of CRF versus protocol to ensure primary and efficacy variables are captured. We have experience of providing sponsor-specific printing requirements, worldwide delivery and bespoke distribution methods.

Data processing/ delivery: CRF Imaging and Workflow

  •     24 hour data entry
  •     Access to CRF images from all global locations
  •     Client access to scanned CRFs and queries
  •     Split-screen data entry

Coding

  •     In-house developed tool – ICOSaurus
  •     Use of integrated coding tools – RAVETM & InForm
  •     MedDRA E & J
  •     WhoDrug E & J
  •     ATC coding by indication
  •     Expertise with coding on sponsor specific tools

SAE Reconciliation

  •     Automatic routing of AEs to Medical group in paper and EDC systems
  •     Email alerts in RAVE and InForm

Integration of Third Party Data

  •     EDC
  •     Central laboratories
  •     Local laboratories
  •     PK
  •     ECG
  •     IVR
  •     ePRO

 

 

 

 

 

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