Clinical Data Acquisition Standards Harmonization

Implement CDASH in DBMS, Tool to automatically convert CDASH compliant raw datasets into SDTM etc.

SDTM - Study Data Tabulation Model

Generic mapping application, Metadata driven approach, Tools to automatically annotate blank CRFs etc.

ADaM - Analysis Data Model

Metadata driven approach, Implement custom macros in standard and validated way, ADaM Define.xml generator etc.

ODM - Operational Data Model

Tool to import CDISC ODM XML format into SAS, Tools to create SDTM & ADaM Define.xml, Tools to create SDTM & ADaM Define.pdf etc.

CDISC Factory

Document IT’s CDISC factory supports and accelerates the set-up of CDISC compliant systems and conversions of legacy clinical trial data to the CDISC standards. By implementing Document IT service delivery lifecycle we can support your CDISC conversion requirements from insourcing key activities to outsourcing complete dedicated projects. Our consultants and virtual team at client site can aid in the conversion process of legacy data at any stage in any role.

CDASH – Clinical Data Acquisition Standards Harmonization

  • Implement CDASH in DBMS
  • Tool to automatically convert CDASH compliant raw datasets into SDTM
  • Rollout SDTM from database at the push of a button

Document IT
Document IT

SDTM - Study Data Tabulation Model

  • Generic mapping application
  • Metadata driven approach
  • Tools to automatically annotate blank CRFs
  • Global macro library
  • SDTM Define.xml generator
  • Tool to automatically create SDRG (Study data reviewer's guide)
  • SDTM validation tool
  • Tool to compare metadata across different trials

ADaM - Analysis Data Model

  • Metadata driven approach
  • Implement custom macros in standard and validated way
  • ADaM Define.xml generator
  • Tool to automatically create ADRG (Analysis data reviewer’s guide)
  • ADaM validation tool
  • Template based reporting system for creating Tables, Listings & Figures (TLFs)
  • Complete control over layout of TLFs
  • Tool to compare metadata across different trials
  • Tool to compare outputs across submissions

Document IT
Document IT

ODM - Operational Data Model

  • Tool to import CDISC ODM XML format into SAS
  • Tools to create SDTM & ADaM Define.xml
  • Tools to create SDTM & ADaM Define.pdf
  • Tool to read Define.xml for metadata validation

Project
Management

Our experienced Project Managers can plan, organize, motivate and control your resources to achieve your specific goal(s).

Quality
Management

For more than 15 years Document IT & its partners have been at the forefront of computerized system validation & IT system compliance.

Quality Management

Business
Consulting

Our consultants work with clients to model & improve business processes, streamline operations & assure compliance.

Business Consulting

Resourcing
Services

Our resourcing services are open to any industry looking for a highly skilled worker.

Outsourcing

We currently offer full business process outsourcing within our CDISC Factory for clinical business processes around the usage of standardized clinical data.

Outsourcing

Bio Statistics

Our expertise includes the design & conduct of clinical experiments, the method & way in which data is collected, analysis of data & interpretation of results.

Clinical
Programming

We offer you comprehensive range of high-quality & cost-effective clinical programming services.

Clinical Programming

Clinical Data
Management

We provide end to end clinical data management solutions from data management plan to database lock.

Clinical Data Management

CDISC
Factory

Document IT’s CDISC factory supports & accelerates the set-up of CDISC compliant systems & conversions of legacy clinical trial data to the CDISC standards.

Records
Management

Document IT maintains the records & documents throughout their life cycle from the time they are created until their disposal.

Records Management
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