Phase II-IIIb

ICON provides a range of integrated services that cover the planning, management, execution and analysis of Phase II – IIIb trials.

Data Management Services


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

All services can be provided as part of a full service solution or on a standalone basis. ICON can also operate as a functional service provider.

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

Database Set-up

CRF Design, Printing & Distribution
 

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.

We have designed over 300 CRFs to date for over 100 clients across all phases and therapeutic areas.

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
  • Imaging

Training

ICON provides a range of courses that can be conducted at client sites.