Statistical Analysis & Programming

CDISC CDASH, SDTM, ADaM, ODM and SEND, CDISC Subject Matter Experts, Statistical analysis datasets according to SAP etc.

Clinical Database Programming

Setup and define database, Central data implementation (such as laboratory data, central ECG readings etc.)

System Management & Administration

Manage metadata servers and workspace servers, Create and assign user groups and user roles and responsibilities etc.

Clinical Programming

At Document IT we offer you comprehensive range of high-quality and cost-effective clinical programming services. We offer accurate data analysis in compliance with regulatory requirements while always being able to adjust to the business needs. We have vast experience in designing, analyzing and reporting clinical studies across a broad range of therapeutic areas that is supported by robust processes and global infrastructure.

Statistical Analysis & Programming

  • CDISC CDASH, SDTM, ADaM, ODM and SEND
  • CDISC Subject Matter Experts
  • Statistical analysis datasets according to SAP
  • Dynamic template based reporting system for creating Tables, Figures and Listings
  • Statistical reports
  • Modular programming method
  • Generic validated macros
  • Standard QC Process

Document IT
Document IT

Clinical Database Programming

  • Setup and define database
  • Central data implementation (such as laboratory data, central ECG readings etc.)
  • Validation checks and queries according to the data validation plan
  • Centralized global macro library
  • Data listings, patient profiles, summary tables and figures
  • Clinical Study Reports and Publications

System Management & Administration

  • Manage metadata servers and workspace servers
  • Create and assign user groups and user roles and responsibilities
  • Continuous administrative and technical support for all clinical information systems
  • Develop and maintain system, user and training documentation
  • System training to end users
  • Evaluate and Implement clinical information systems and data management platforms (EDC,CTMS, eTMF, eDiaries, payments systems, electronic regulatory filings etc.)
  • Adherence to standards in clinical systems

Document IT

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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