eClinical Services

Get Your Clinical Trials Right First Time With Our Integrated eClinical Services

IDDI eClinical Services: One Single Portal for Randomization and Trial Supply Management RTSM, and EDC 

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IDDI is an eClinical services provider and functional CRO that combines advanced biostatistics with innovative and integrated online data-collection technology to increase efficiency and mitigate risks throughout clinical trials and the drug development process.

Today’s eClinical solutions need to be flexible and scalable for all clinical trial phases. Our systems are intuitive and configurable. By using our robust, validated and integrated best-in-class eClinical solutions, you will improve the efficiency of your clinical data collection and eradicate duplication in data collection by a using a single portal. IDDI takes you from study initiation to database lock in the shortest possible time without compromising the accuracy and quality of your data throughout the process. We do not cut corners but know that you can’t afford anything else but to get it right first time!

Our user-friendly Electronic Data Capture (EDC) solution, which is FULLY INTEGRATED with our in-house Randomization and Trial Supply Management (RTSM), including a drug supply management feature, is uniquely competitive. This modular composition of our electronic platform allows for flexibility, accelerates clinical studies for our Sponsors and lowers the overall cost for data management.

  • Randomization (RTSM) (ID-net™)
    • Supports all types of randomization schemes (fixed, dynamic, multi-stage, adaptive)
    • Various features; study drug tracking and inventory management, patient registration and withdrawal, emergency code break
    • Notifications, alerts and on-line reporting
    • Interface compatible with tablets and smartphones
    • One single login for investigator to access all participating studies eClinical services
    • Can be plugged into any EDC
  • Electronic Data Capture – EDC (ID-base™ powered by XClinical)
    • True end-to-end workflow based on CDISC standards
    • Automatic set-up of eCRFs and data validation plan by uploading CDISC metadata
    • CDISC data import and export, full CDISC ODM and PDF archiving
    • Source data verification for documentation by monitors
    • Dynamic online reports, embedded business intelligence and reporting tool
    • Patient-reported outcome (ePRO/eCOA) via web diary
    • Binary data input, such as X-rays, images, ECGs
  • Medical coding (ID-code™)
    • Using MedDRA and WHO-Drug dictionaries, part of IDDI’s data management process
    • Online reports and real-time access to key data

Features and Benefits of IDDI eClinical Services

INTEGRATED SYSTEM Users log on to one system
OPEN INTERFACES Facilitates connection with third-party systems with easy plug in
EASE OF USE Limited training required; intuitive for sites and monitors
STANDARDIZED REPORTS Cost savings; eliminates re-creation of reports
FLEXIBLE Easy protocol amendment management
STUDY COMPOSER Increases consistency and accelerates design of eCRFs, saving costs
FULL INTEGRATION The randomization is performed by the site using the EDC system, which relies in the background on ID-net web services to perform randomization and treatment allocation. This allows a single front-end for the site and the adoption of advanced randomization schemes (for example, minimization) that EDC technology alone does not offer

All systems are tested and validated by IDDI’s team of specialists, independently from the team of developers, before sponsor’s validation and go-live.

Our secured, encrypted web systems are compliant with FDA 21 CFR part 11, ensuring total data quality and protection, and are supported by a worldwide, in-house 24/7 Help Desk staffed by highly qualified IDDI employees, covering all continents around the clock.

All of our processes are adaptive, allowing easy implementation of clinical trials to enable smooth study initiation, conduct, and closure.

READ: PRACTICAL CONSIDERATIONS FOR ADAPTIVE TRIAL DESIGN AND IMPLEMENTATION Chapter 12 ‘Implementation issues in adaptive design trials’ Linda Danielson, Jerome Carlier, Tomasz Burzykowski, Marc Buyse