NEW: Read eCOA Best Practices by Major Pharma Leaders     Download Now

Paired with every protocol to ensure regulatory compliance, optimal study power

The PRO eCOA Clinical Science and Consulting Team has more than 200 years of collective experience in electronic patient reported outcomes (ePROs) and clinical outcome assessments (COAs).  The team facilitates pharmaceutical researchers and clinicians to implement optimal PRO/eCOA trial design strategies to ensure the success of drug development programs, with a dual layer of PRO and eCOA best practices. Instruments and programs are developed with electronic implementation in mind, resulting in each customized eCOA program of high quality and data accuracy. With the largest resident PRO/eCOA Science Team in the industry, ERT ensures optimal study power using

  • Endpoint design practices proven to efficiently collect well-chosen eCOA endpoints;
  • Electronic instrument development and validation to ensure instruments are fit for purpose; and
  • Customized rater training for clinician, caregiver, patient and site staff which safeguard the standardized use of each well-developed instrument.
  • image

    Download Brochure

    CSC-Brochure

Paired with every protocol to ensure regulatory compliance, optimal study power

With the largest resident PRO/eCOA Science Team in the industry, ERT ensures optimal study power using

  • Endpoint design practices proven to efficiently collect well-chosen eCOA endpoints;
  • Electronic instrument development and validation to ensure instruments are fit for purpose; and
  • Customized rater training for clinician, caregiver, patient and site staff which safeguard the standardized use of each well-developed instrument.
  • image

    Download Brochure

    CSC-Brochure

Instruments must be well-designed; users must be well-trained. ERT eCOA Scientists are paired with every protocol, to ensure regulatory compliance and optimal study power. In addition, ERT Scientists Team:

  • Develop and validate instruments for eCOA
  • Migrate paper PRO, ClinRO, ObsRO, and PerfO instruments to electronic implementations
  • Conduct patient testing for equivalence and psychometric validation
  • Manage license agreements and translations
  • Interpret FDA/EMA guidelines for submissions
  • Perform instrument and data analyses including meta- and post-hoc reviews
  • Develop algorithms for weighting and scoring assessments
  • Conduct active eCOA studies

As an additional service to expedite study set-up, the eCOA Science team actively migrates and certifies paper instruments on ERT devices.  Learn which instruments are available. The ERT Clinical Science Pipeline strengthens eCOA study power by generating evidence on patient, caregiver, clinician and site staff understanding and ease of use for collecting clinical data electronically. Study results enable ERT eCOA to design more intuitive and appealing screens to collect definitive endpoints and enhance patient/physician communications.

Instruments must be well-designed; users must be well-trained. ERT eCOA Scientists are paired with every protocol, to ensure regulatory compliance and optimal study power. In addition, ERT Scientists Team:

  • Develop and validate instruments for eCOA
  • Migrate paper PRO, ClinRO, ObsRO, and PerfO instruments to electronic implementations
  • Conduct patient testing for equivalence and psychometric validation
  • Manage license agreements and translations
  • Interpret FDA/EMA guidelines for submissions
  • Perform instrument and data analyses including meta- and post-hoc reviews
  • Develop algorithms for weighting and scoring assessments
  • Conduct active eCOA studies

As an additional service to expedite study set-up, the eCOA Science team actively migrates and certifies paper instruments on ERT devices.

ERT eCOA Clinical Science Research

In 2014 and 2015, ERT Clinical Scientists authored:

  • 9 manuscripts published or accepted for publication in peer-reviewed journals
  • 1 published book chapter
  • 11 sessions chaired or presented at national and international scientific conferences
  • 17 therapeutic-specific eCOA scientific webinars
  • 36 posters presented at national and international scientific conferences
  • image

    Download Brochure

    eCOA data