Iddi

IDDI: Expert Clinical Data Services for Submission-Ready Clinical Data

IDDI is a leading provider of expert clinical data services that help pharmaceutical, biotech, and medical device companies design and conduct clinical trials with confidence. With over 30 years of experience in the industry, IDDI has established itself as a trusted partner for study design, randomization and trial supply management (RTSM), clinical data management (CDM), biostatistics, and submission-ready clinical data.

At IDDI, we understand the importance of high-quality clinical data in drug development. Our team of experts works closely with our clients to ensure that their studies are designed to meet regulatory requirements and produce reliable results. We use innovative statistical methods to optimize study designs and minimize risks associated with sample size determination.

Our RTSM solutions are designed to simplify the process of managing trial supplies while ensuring accurate randomization. We offer flexible options for interactive response technology (IRT) systems that can be customized to meet specific study needs.

In addition to RTSM, we provide comprehensive CDM services that include database design and build, electronic case report form (eCRF) development, data validation checks, query management, coding dictionaries creation/maintenance as well as medical coding according to MedDRA/WHO-DD standards.

Our biostatistics team provides expert statistical analysis throughout all phases of drug development from early phase I studies through post-marketing surveillance studies. Our statisticians have extensive experience in designing adaptive trials using Bayesian methods which allow us to make more efficient use of available information during the course of a trial.

At IDDI we pride ourselves on delivering submission-ready clinical data on time every time. Our experienced project managers work closely with our clients throughout each stage of their project ensuring timely delivery within budget constraints while maintaining high quality standards.

We also offer consulting services including regulatory support such as preparation for FDA meetings or EMA scientific advice meetings; strategic planning; protocol review; risk-based monitoring strategy implementation; CDISC implementation support among others.

In conclusion,

IDDI is an industry leader in providing expert clinical data services including study design optimization using innovative statistical methods; RTSM solutions tailored specifically for each client's needs; comprehensive CDM services including eCRF development/validation checks/query management/coding dictionaries creation/maintenance/medical coding according MedDRA/WHO-DD standards ; Biostatistics expertise from early phase I studies through post-marketing surveillance studies using adaptive trials based on Bayesian methods which allow us make more efficient use available information during course trial ; Consulting Services such as Regulatory Support Preparation FDA Meetings or EMA Scientific Advice Meetings Strategic Planning Protocol Review Risk-Based Monitoring Strategy Implementation CDISC Implementation Support among others . With over 30 years' experience working alongside pharmaceuticals/biotechs/medical devices companies worldwide , IDDI has established itself trusted partner submission-ready clinical data delivered time every time within budget constraints while maintaining high quality standards .