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CDISC SDTM Team Related information

Data Management

Our project teams of qualified Data Management Project Leaders, Data Managers, Programmers, Medical Coders specialize in data collection and validation as well as the programming of the SAS clinical trial database.

The Data Management team centralizes the data from a trial including EDC (Electronic Data Capture) as well as all external data such as PK, Central Labs, PD or Imaging. Throughout the project they are in charge of reconciliation and data cleaning efforts.

Trial oversight from the sponsor is facilitated by offering access to adapted dashboards and tools. This covers operational oversight as well as access to data monitoring deliverables such as safety data listings or patient profiles.

biotrial-data-management

CDISC SDTM

Biotrial has been offering SDTM deliverables to sponsors since 2010. All processes and templates are CDISC-compliant, and we also have the possibility of mapping legacy data into SDTM for our clients.

SDTM compliance is managed by the internal CDISC governance group who participates in regular CDISC workshops and is in charge of maintaining processes and tools as well as training Biotrial staff.

Our team is experienced in adhering to Biotrial’s CDISC standards. Additionally, we collaborate with various sponsors who have their own CDISC implementation.

  • SDTM Datasets
  • Define.xml and Reviewer’s Guide
  • For preclinical projects: SEND package

TEAM

DM Project Leaders

Lead the project for all DM elements. Oversee all document preparation and programming

SAS Programmers

Program SDTM database and all deliverables such as patient profiles, data listings, define.xml

SDTM Experts

Global oversight for all SDTM activities: regulatory monitoring, training team members, interacting with sponsor counterparts, maintaining Biotrial tools

Data Managers

Assist DM Project Leaders in all DM steps of a project

Participate in a clinical trial

Volunteer in France
Volunteer in USA
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