Protocol/Statistical Analysis Plan (SAP)

Study design, Sample size calculation & power determination, Randomization & blinding scheme etc.

Statistical Analysis & Programming

Interim statistical analysis for adaptive designs and DSMBs (Data and Safety Monitoring Boards), Data analysis for preparing integrated study reports etc.

Statistical Reporting

Statistical reports following the SAP, Statistical sections of Clinical Study Reports (CSR), Statistical sections of integrated study reports.

Other Services

Statistical training, Clinical trial planning and design, Medical writing, Statistical consultancy etc.

Bio Statistics

Document IT has vast experience in the evaluation of clinical data. Our expertise includes the design and conduct of clinical experiments, the method and way in which data is collected, the analysis of data, and the interpretation of results. Our expertise in regulatory submissions and knowledge of biostatistics helps you to navigate the complexities of study design, randomization, sample size calculation and data visualization etc.

Protocol / Statistical Analysis Plan (SAP)

  • Study design
  • Sample size calculation and power determination
  • Randomization and blinding scheme
  • Statistical methodology according to the study design and type of variables
  • Describe primary and secondary end points
  • Evaluate safety/efficacy parameters

Document IT
Document IT

Statistical Analysis & Programming

  • Interim statistical analysis for adaptive designs and DSMBs (Data and Safety Monitoring Boards)
  • Data analysis for preparing integrated study reports
  • Exploratory analysis for publications, abstracts, and marketing
  • Analysis of non-clinical trial data from epidemiologic studies and pre-clinical studies

Statistical Reporting

  • Statistical reports following the SAP
  • Statistical sections of Clinical Study Reports (CSR)
  • Statistical sections of integrated study reports
  • In-text tables presenting the main results
  • Patient listings in appendices
  • Conclusion reports written with input from clients

Document IT
Document IT

Other Services

  • Statistical training
  • Clinical trial planning and design
  • Medical writing
  • Statistical consultancy
  • Participation in Data Safety Monitoring Boards and Adjudication Committees
  • Regulatory affairs
  • Biometrics

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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