IDDI, Biostatistical and eClinical Services for Clinical Trials

TRIAL DESIGN - RANDOMIZATION - DATA MANAGEMENT - BIOSTATISTICS
Twitter icon
Facebook icon
LinkedIn icon
Google+ icon
YouTube icon
RSS icon

Secondary menu

Home > Content > ADDING VALUE TO PHARMA

ADDING VALUE TO PHARMA

Services for pharma companies

Your needs:

You have all capabilities for conducting clinical trials in-house or you need to rely only on your preferred providers. However, you may need an independent group to support your DSMBs (Data Safety Monitoring Boards) or IDMCs (Independent Data Monitoring Committees).
You are looking for an Expert Biostatistician (ScD, PhD) to be part of your Steering Group or act as a Consultant in specific designs matters, or be involved in biomarkers clinical validation.
You are in Medical Affairs, responsible for outsourcing and are therefore looking for a full service CRO or a functional CRO to provide specific service for your clinical trials.
 

 All these tasks require thorough expertise in Biostatistics and this is typically where IDDI can be of benefit to you.  IDDI offers a packaged solution including protocol writing with the optimal design for your trial, cost-effective data management with EDC (integrated with IWRS for your central randomization needs), professional statistical analyses and medical writing (either for clinical study reporting or for publications).
 

Our Services:

STATISTICAL SUPPORT TO IDMC

 

IDDI has been involved in over 70 trials as independent statisticians over the last 5 years, and will be happy to serve your next Board in a professional manner.

 

We can help you identify and recruit the IDMC members, write or review the Charter, organize the meetings, program, produce and report the analyses to the members (Design the templates, ensure the data transfer from Sponsor or CRO, do the Blinded or unblinded analyses, post all documents and reports on IDDI’s Secure web platform in a confidential manner, provide the Tables, figures and listings for interim analyses, write the blinded/unblinded reports).

TRIAL DESIGN

 

IDDI Consultants are uniquely positioned to provide such high added value statistical expertise.

 

If you need advanced and innovative statistical designs (such as adaptive Bayesian designs) that can be presented to regulatory agencies, IDDI is uniquely positioned to provide such high added value statistical expertise, thanks to its founder, Professor Marc Buyse, Doctor in Biostatistics, Professor Tomasz Burzykowski, PhD in Biostatistics and Dr. Stefan Michiels of the Institut Gustave Roussy in Paris and Dr. Everardo Saad, Founder and CEO Dendrix, Senior Oncology Consultant

STATISTICAL VALIDATION OF BIOMARKERS

 

IDDI has the experience and independence required to carry out convincing validation studies, as demonstrated by its track record and publications.

 

IDDI has been active in developing statistical methodology for the identification and validation of biomarkers, gene signatures or protein expression, either as prognostic biomarkers (biomarkers that affect the outcome of patients in terms of a clinical endpoint), either as 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) 

 

User-friendly, cost-effective IWRS developed in-house and  easily plugged in to your EDC 

 

IDDI is a pioneer in central randomization since over 15 years, at the time via an operator, then IVRS and since 1999, IWRS all developed in-house and now fully integrated in our EDC. ID-net™ is a user-friendly, cost-effective, rapidly implemented IWRS, customized to your protocol and needs, validated 21 CFR Part 11 tool, supporting all types of randomization schemes (minimization, adaptive, permuted blocks ...) and accessible by all browsers. Along with patient randomization and treatment allocation, other features are included such as: 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 over all continents.

 

TAKE NO RISKS :
Rely on IDDI’s loyal team of highly skilled professionals who have served pharmaceutical companies for 23 years! And join 30% of IDDI’s clients base which are pharmaceutical companies.