Clinical Data Management

From database setup and cleaning to reporting and database lock, IDDI’s regulatory-compliant clinical data management tools and experts deliver timely, accurate, and quality data. 

The End-to-End Clinical Data Management Solution

Our data managers provide everything from eCRF implementation to clinical database lock, for all therapeutic areas.

Electronic Data Capture

Our experts set up and manage electronic data capture (EDC) with ID-base (Marvin) powered by EvidentIQ or Rave powered by Medidata.

Explore Our EDC Solutions

SDTM – Data Standards Implementation

As a CDISC Registered Solutions Provider, we convert your clinical data to CDISC SDTM standards.

Explore Our SDTM Solutions

Medical Coding

We provide medical coding services via IDDI’s Coder (ID-Code) or Medidata’s Rave Coder using MedDRA and WHODrug dictionaries. 

Industry-Leading Clinical Data Managers

With extensive scientific backgrounds, our clinical data managers not only oversee your study’s data management tasks and refine your requirements. We’re dedicated to achieving the highest level of efficiency, making sure your study’s data are handled with the utmost proficiency and care.

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Your Top-Tier Clinical Data Management Team

When you partner with IDDI for clinical data management (CDM) services, you’re assigned a dedicated team of CDM professionals who will be by your side every step of the way.

Your team includes:

Your primary contact for all CDM-related activities, your lead clinical data manager will follow your trial from setup until database lock and submission. At IDDI, we aim to keep the same lead clinical data manager on a project to ensure that the knowledge/history of the protocol and all data decisions made are maintained and shared with the study team members, whether internal or external.

Your EDC specialist plays a pivotal role during both the setup of your EDC system and any subsequent amendments/changes. They apply their technical knowledge and creativity to ensure the Electronic Case Report Form (eCRF) is built efficiently. In collaboration with the lead clinical data manager, they design the most useful and helpful online metrics, listings, and reports, facilitating a close monitoring of your study.

You are assigned programming specialists at eCRF setup to ensure CDASH compliance and a smooth conversion to CDISC SDTM format. The programming specialists also take care of reports and listings not handled by the EDC system to accommodate for data review and cleaning activities to guarantee a tight follow-up on pending data issues.

Your coding specialist is responsible for accurately assigning standardized medical codes to the adverse events, medical conditions, and procedures documented within the trial using standard MedDRA and WHO Drug dictionaries. Their role is crucial in ensuring consistency and accuracy in the reporting of medical coding data across different study sites and among various clinical trial phases.

Your clinical data reviewers perform thorough reviews of data (External, EDC, and/or SAS), identifying discrepancies, errors, and inconsistencies, and generating queries to address and resolve these issues. They collaborate closely with other members of the clinical research team to ensure data quality and integrity throughout the study conduct.

Your biostatisticians are tasked with reviewing the case report form (CRF) to confirm that all necessary data for their analysis are collected appropriately, aiming to minimize the risk of database modifications or, in worse cases, database unlocks. 

Make Your Data
Work for You

Rely on IDDI’s expertise and proven clinical data management processes to perfectly handle your data from start to finish.

Clinical Data Management Services Ensure You’re Ready for Submission