CDISC Roadmap

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Business & Decision Life Sciences offers a couple of key consultancy services for sponsors wishing to adopt or work with CDISC standards.

These services include:

  • CDISC readiness assessment: interview-driven process to evaluate the maturity of the biometrics systems and processes with regards to CDISC data standards and guidelines.
  • CDISC implementation roadmap: customized workshops with presentations on current regulatory requirements and CDISC data standards.

CDISC Readiness Assessment

The scope of the assessment will include an in-depth investigation at a system, process and resource level.

The CDISC readiness report will evaluate and score the maturity of the biometrics environment with regard to the use of the CDISC data standards and guidelines.

Our evaluation will address some key questions:

Are we ready for CDISC near/longer term?

If not, what are the options?

What will it cost?

What is the return on investment?

 

Business & Decision Life Sciences' consultants will interact with different levels of the sponsor's organization in an efficient, interview-driven manner.

CDISC implementation roadmap

Business & Decision Life Sciences will help you to implement data standards on different levels of your systems and processes.


The implementation roadmap will include:

  • Different approaches and methodologies
  • Evaluation of the required resources
  • Implementation phases and timelines
  • Impact analysis on systems, processes and resources
  • Cost estimation
  • Training plans for all different roles of the project staff
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