IDDI - Regulatory Statistics & Clinical Data Science Experts

What we do: IDDI is a globally recognized contract research organization (CRO) specializing in regulatory statistics, clinical data science, and high-level strategic consulting for the pharmaceutical, biotechnology, and medical device/diagnostic industries. Our core services include clinical development strategy, study design, protocol development, biostatistics, biomarker and IVD validation, clinical data management, randomization and trial supply management (RTSM), electronic data capture (EDC), and regulatory submissions support. We help clients navigate complex clinical trials from Phase I to IV, ensuring data quality and integrity for successful regulatory approval in the US and Europe. Our therapeutic expertise spans oncology, ophthalmology, central nervous system (CNS), rare diseases, cardiology, infectious diseases, and immunology. With over 1,400 clinical trials completed, IDDI is a trusted partner for companies seeking agile, expert-driven solutions to accelerate drug development and achieve market approvals.

Where we are located: IDDI’s global headquarters is located at 7751 Brier Creek Parkway, Suite 204, Raleigh, North Carolina, 27617, USA. The company also maintains a significant presence in Europe, with offices in Ottignies-Louvain-la-Neuve, Belgium.

Short history: Founded in 1991, IDDI has over 30 years of experience as a pioneer in eClinical and biostatistical services. The company has contributed to more than 15 market approvals in the US and Europe, reflecting its deep regulatory and scientific expertise. IDDI’s growth has been driven by a commitment to innovation, including the development of proprietary technologies for randomization, data management, and electronic data capture. The company’s legacy is marked by a prolific portfolio of expert publications and a strong presence at international medical and statistical conferences.

Organization & culture: IDDI employs a team of highly skilled professionals, including biostatisticians, data managers, medical writers, and regulatory experts. The company fosters a scientifically driven, collaborative culture, working closely with academics and key opinion leaders to stay at the forefront of clinical practice. IDDI’s values emphasize passion for science, commitment to data quality, and a client-focused approach to delivering tailored, efficient clinical trial solutions. The organization is known for its agility, global reach, and ability to handle complex, multidisciplinary projects across therapeutic areas.