Your Partner for Submission-Ready Clinical Data

For superior market differentiation and data-driven decisions
Secure optimal data analysis and interpretation across indications and phases with tailored solutions:

• Advanced biostatistical analysis

  We customize our services to deliver optimal data analysis and interpretation across all therapeutic areas, study phases, and milestones.

• Data standards – ADaM implementation

  As a CDISC-registered provider, IDDI meticulously aligns every trial with FDA electronic submission standards, delivering database structures seamlessly transformed into ADaM formats and accompanied by the requisite documentation.

• Interim analysis – Independent Data Monitoring Committee (IDMC)

  We provide succinct, complete, well-structured, and reproducible reports that clearly show the trial’s risk-benefit profile. We also serve as a liaison between you and the committee, helping them efficiently identify safety trends and make well-informed recommendations.

• PK/PD

  Combining scientific rigor and cross-functional collaboration, we ground your program in scientific modeling and statistics to optimize decision-making and mitigate risk.

For data you can trust and efficiency you can feel
Maintain high-quality data throughout your study, minimize corrections at the end, and accelerate database lock with services such as:

• SDTM – Data Standards Implementation

  As a CDISC-registered provider with experience handling SDTM in more than 100 studies, we efficiently develop eCRFs to CDASH standards and deliver data in SDTM format.

• Medical coding

  We provide medical coding services with our Coder (ID-Code) or Medidata’s Rave Coder using MedDRA and WHO Drug dictionaries.

• eCRF implementation

  IDDI programming specialists ensure CDASH compliance, a smooth conversion to CDISC SDTM format, and efficient handling of reports and listings not managed by the EDC system.

• Data review

  IDDI clinical data reviewers perform thorough reviews of data, identifying discrepancies, errors, and inconsistencies, and generate queries to address and resolve these issues.

• EDC

  We handle EDC system setup and any subsequent amendments or changes.

For faster market entry and reduced risk
Design and launch clinical trials that ask the right questions and meet stringent regulatory requirements with consulting services that include:

• Study design

  From determining the right sample size and appropriate endpoints to randomization techniques and more, we solidify your trial’s foundation and maximize the potential for your drug’s approval.

• Regulatory statistics

  IDDI regulatory statistics specialists make sure your statistical methods are scientifically sound, meet regulatory requirements, and enhance the credibility of data submitted for approval.

• Clinical development plan optimization

  Based on the available preclinical data and clinical results, we help you with strategic decisions regarding further clinical drug development and product approval.

• Regulatory support

  We use our regulatory expertise — spanning IND and NDA submissions, pediatric exclusivity, rare diseases/orphan drug designation, and IVD and medical device clearances and approvals — to help you confidently navigate your journey to approval.

For even more speed, accuracy, and oversight
Configure your study and capture, manage, and analyze every data point with advanced eClinical software including:

• EDC

  Our experts set up and manage EDC with Marvin, Rave, or Veeva EDC.

• Randomization and Trial Supply Management (RTSM)

  We combine RTSM know how with statistical expertise and industry-leading technology to safeguard your study.

• One2Treat

  We align your development program with what patients really need to optimize outcomes.