Pro and ePRO Services

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Business & Decision Life Sciences delivers high quality and exploitable Patient-Reported Outcome (PRO) data to evaluate the clinical benefits and values of your products.

Business & Decision Life Sciences has a unique combination of skills, experience, and tools to face the increasing demand of PRO and electronic PRO (ePRO) data and to produce valid (e)PRO data that support a label claim and regulatory and reimbursement submissions and to capture the voice of the patients in real-world conditions.

Our services

ePRO: what we do

 

  1. Select the right PRO measure:
    • Provide expert consultancy services to help Life Sciences companies to select the most appropriate PRO measure to include in their clinical trials.
    • Define PRO strategy.
    • Conduct in-depth literature, PRO-label databases, and competitor reviews.
    • Analyze and compare the psychometric properties of existing questionnaires.
  2. Adapt the original paper PRO measure into a new electronic interface:
    • Adapt the paper version of the measure into an electronic interface which can be applied to different devices (e.g., computers, phone).
    • Electronic PRO (ePRO) system validation.
    • Conduct equivalence and usability studies.
  3. Implement the ePRO measure in the clinical trial:
    • Ensure that the ePRO measure is properly embedded in the clinical trial.
    • Provide sites and patients training and support.
    • Ensure secure data hosting and back-up.
    • Clean ePRO data using data consistency checks and listings.
    • Export data into a CDISC format.
  4. Analyze PRO data :
    • Identify appropriate measurement strategies and assessment methods.
    • Develop the Statistical Analysis Plan.
    • Perform the statistical analysis of the PRO data.
  5. Develop PRO publications/reports:

Benefits

  • Selection of the most relevant PRO measures
  • Improved data integrity and protocol compliance through the ePRO solution
  • ePRO measure properly implemented in the clinical trials
  • ePRO data properly hosted and managed
  • Relevance of the psychometric and statistical analyses applied to the ePRO data
  • High quality writing assistance

Contact us

life.sciences@businessdecision.com

Call +32 2 774 11 00

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