CRF Design & Annotation

Define standard modular CRF library, CRF design for EDC, paper, or scanned formats etc.

Database Management

Implement CDISC CDASH (Clinical Data Acquisition Standards Harmonization) standards in database design, Data Management Plan (DMP) etc.

Data Entry

Independent double data entry with interactive reconciliation, Generate audit trail, Central laboratory database imports etc.

Database Documentation Tracking & Reporting

Creation and maintenance of data management documents, Status reports and administrative listings etc.

Clinical Data Management

Document IT’s Clinical data management team focuses on the generation of high-quality, reliable, and statistically sound data from clinical trials. We have extensive experience in all therapeutic areas of data management from Phase I-IV clinical trials. We provide end to end clinical data management solutions from data management plan to database lock.

CRF Design & Annotation

  • Define standard modular CRF library
  • CRF design for EDC, paper, or scanned formats
  • Professional review of study protocols and alignment of CRF and protocol
  • CRF completion guidelines based on the protocol
  • Automatic annotation of blank CRFs for CDISC SDTM
  • Automatic annotation of scanned paper CRFs for indexing

Document IT
Document IT

Database Management

  • Implement CDISC CDASH (Clinical Data Acquisition Standards Harmonization) standards in database design
  • Data Management Plan (DMP)
  • Data Validation Specification (DVS)
  • Coding of medical terms according to scientific dictionaries (MedDRA and WHODRUG)
  • Query Management
  • Reconciliation of Laboratory/Vendor/ or any external data
  • Data transfer to client along with metadata and data consistency reports
  • SAE Reconciliation
  • Database lock

Data Entry

  • Independent double data entry with interactive reconciliation
  • Generate audit trail
  • Central laboratory database imports
  • Incorporating third party databases
  • Import & export CDISC ODM XML in database

Document IT
Document IT

Database Documentation, Tracking & Reporting

  • Creation and maintenance of data management documents
  • Status reports and administrative listings
  • Dashboards for study status
  • High level reports for data consistency and integrity
  • QC/QA documentation for project-specific guidelines and SOPs
  • Study documentation

Project
Management

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

Project Management

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.

System Architecture Services

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.

Bio Statistics

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.

CDISC Factory

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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