IDDI continually builds on its proven track record in statistical design and analysis, randomization and data management to maintain industry leadership.
> The biostatistics department is one of most important contributors to clinical development programs, ensuring optimal protocol and trial design, also performing trial simulations.
The department has extensive experience with Data Safety Monitoring Boards, its charter development, logistics and interim safety and efficacy analyses. Statisticians use state-of-the-art software such as SAS ® or S-plus ® in addition to specialized software such as StatXact ®, EaSt ®, etc.
> The data management department uses off the shelf software (MARVIN of XClinical) to increase the efficiency of data entry, data access and query resolution for both paper and electronic CRFs.
In addition, the department benefits from performant in-house technology for medical coding (ID-codeTM) and web-based data access and reporting (TrialControlTM).
> Clinical operations (site selection, on-site monitoring ...) are contracted out to a preferred CRO.
> Regulatory Affairs is outsourced to a privileged partner.
> Medical writing is outsourced to medical writers according to their specific domain of expertise. Medical writing includes literature searches, development of clinical trial protocols and associated documentation, production of reports based on international guidelines such as ICH, or publications for medical journals and conferences.