IDDI, Biostatistical and eClinical Services for Clinical Trials

TRIAL DESIGN - RANDOMIZATION - DATA MANAGEMENT - BIOSTATISTICS
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ADDING VALUE TO CRO

Services for Contract Research Organizations

Your needs:

As a full service CRO, providing a comprehensive range of services to your clients, you may need an independent statistician or team to support your DSMBs (Data Safety Monitoring Boards) or IDMCs (Independent Data Monitoring Committees). You may also require an expert Biostatician (ScD, PhD) to be involved in statistical validation of biomarkers.
You may also want to offer Randomization and Trial Supply Management services but do not have the capabilities in-house.
 

Our Services:

IDDI is able to support your ‘one-stop-shop’ approach by providing you with the following solutions:

  • Interactive Web Response Services (IWRS) for Randomization and Trial Supply Management
  • Data Management Services
  • Biostatistics

We have over 22 years of experience and are adept at cultivating long-term working partnerships that support Clinical Operations and interface seamlessly with your own approach. 
 

 IDDI offers a cost-effective data management solution, integrating EDC, IWRS and best in-class statistical analyses and medical writing (either for clinical study reporting or for publications).

 

 

STATISTICAL SUPPORT TO IDMC  

Since 2008, IDDI has been involved in over 70 trials as independent statisticians, and we are perfectly placed to serve any of your DSMB needs in a professional manner. 

 

IDMC Support

We can help you identify and recruit the IDMC members, write or review the Charter, organize the meeting program and produce and report the analyses for the members (including design of the templates and ensuring the data transfer from Sponsor or CRO, blinding or unblinding analyses, posting all documents and reports on IDDI’s Secure web platform in a confidential manner, providing the tables, figures and listings for interim analyses, and writing the blinded/unblinded reports).
 

 

 

STATISTICAL VALIDATION OF BIOMARKERS 

IDDI has the expertise and independence required to carry out convincing validation studies, as demonstrated by its unrivaled track record and comprehensive list of publications.

 

IDDI has been active in developing statistical methodology for the identification and validation of biomarkers, gene signatures or protein expressions, either as prognostic biomarkers (biomarkers that affect the outcome of patients in terms of a clinical endpoint), predictive biomarkers (biomarkers that affect the effect of a specific treatment on a clinical endpoint), or as surrogate biomarkers (biomarkers that aim at replacing a clinical endpoint in clinical trials carried out to evaluate the effect of a specific treatment). A limited number of prognostic and predictive biomarkers have already been identified, but a far larger number of them are potentially ready for validation.
 

 

 

INTERACTIVE WEB RESPONSE SYSTEMS (IWRS)  

Our EDC system integrates seamlessy with IWRS (ID-net™) offering you a powerful eClinical platform

 

IDDI is a pioneer in central randomization having been involved in developing and enhancing  these solutions for over 15 years, beginning  with an live operator, then using IVRS technology and since 1999  in the form of a web-based solution (IWRS) developed in-house and now fully integrated with our EDC systemID-net™ is a user-friendly, cost-effective, rapidly implemented IWRS, customized to your protocol and operational needs.It is a validated 21 CFR Part 11 tool, supporting all types of randomization schemes (minimization, adaptive, permuted blocks etc.) and accessible by all Internet browsers and versions. Along with patient randomization and treatment allocation, other features include: study drug tracking and inventory management, code break, patient screening, registration and withdrawal. The system allows notifications, alerts and on-line reporting.
A 24/7 helpdesk is available covering all time zones

 

 

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TAKE NO RISKS FOR YOUR CLIENTS: 
Rely on IDDI’s loyal team of highly skilled professionals who have served bio/pharmaceutical companies for over 23 years!