ETDRS BCVA Solutions

MERIT offers comprehensive training, certification, and management of study Best Corrected Visual Acuity (BCVA) activities as well as centralized data review of BCVA source documents.

With MERIT, you benefit
from the following:

  • EXPERT ETDRS BCVA CERTIFICATION TEAM: Our certification team members have extensive clinical and teaching backgrounds in ophthalmology and/or optometry, and have performed BCVA certification in multiple ophthalmology clinical trials
  • CENTRALIZED DATA REVIEW AND CERTIFICATION TRACKING WITH SINGLE SYSTEM CONVENIENCE: Efficient and accurate upload and centralized data review of ETDRS BCVA source documents in our proprietary software, EXCELSIOR. The same system is used to track training certifications
  • COLLABORATIVE PARTNERSHIP: We prioritize a collaborative, partnership-driven approach for all projects with scalable solutions and personalized attention
SERVICES INCLUDE:
  • Full and express ETDRS BCVA technician certification
  • BCVA lane certification
  • Certification forms maintained in EXCELSIOR
  • Confirmation of acceptable equipment
  • Tracking and scheduling of site training and certification
  • Upload and centralized review of BCVA source docs in EXCELSIOR™

IMPORTANCE OF ETDRS BCVA

Early Treatment Diabetic
Retinopathy Study (ETDRS)

BCVA is the primary endpoint for vision in many ophthalmic clinical trials. Standardized measurement and collection of BCVA is key for successful trials. Standardization through certification and centralized data review supports accurate quantification of vision and consistent measures of vision change.

ETDRS BCVA Certification

BCVA certification assures Sponsors that clinical trial site personnel are adequately trained in performing BCVA assessments in a standardized and correct way. In addition, lane certification ensures that all lane and exam room requirements are met.

Centralized Data Review of ETDRS BCVA

Given the importance of BCVA as the primary endpoint for the majority of ophthalmic clinical trials, prompt and accurate review of the BCVA source documents by an ophthalmology specialist is critical. Centralized data review allows sponsors to provide more efficient oversight, with the potential for reduced risk and lower costs.

IN-DEPTH INFORMATION ON MERIT’S ETDRS BCVA SERVICES

Upload and Centralized Data Review
of ETDRS BCVA Source Documents
  • MERIT’s cloud-based EXCELSIOR platform allows immediate upload of source documents directly from qualified sites to a central database for centralized data review, without installing software or configuring
    firewalls. This elevates efficiency and accuracy in the acquisition and upload of BCVA source docs
  • Our centralized data review of BCVA source documents in EXCELSIOR can easily be configured to meet sponsor and study requirements. Our expert data review team can help ensure BCVA values are accurate
Full and Express ETDRS BCVA Technician Certification
  • Development of detailed BCVA and refraction procedural manuals for ophthalmic technicians for certification
  • Full site technician certification to include training session and certification assessment
  • Express technician certification assessed through questionnaire, online meeting, or phone call
ETDRS BCVA Lane Certification
  • Evaluation of lane condition including lane environment, space, and equipment access
  • Checklist for lane preparation provided prior to certification
  • Certification assessment and documentation
Confirmation of Acceptable Equipment
  • Review and confirmation of acceptability of BCVA equipment may be performed at sponsor’s request
Certification Forms Maintained in EXCELSIOR
  • Technician and lane certification forms maintained in EXCELSIOR
Project and Site Management
  • Distribute BCVA and refraction procedural manual to site staff
  • Develop and distribute a site survey to discover who at the site will need to certify for BCVA and refraction procedures as well as information about the site equipment
  • Track and schedule site training and certification
  • Provide coordination among sites, certification team, sponsor, and others (as applicable)
If you’re looking for a ETDRS BCVA services provider that will value your partnership and make your study a priority, consider MERIT.

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YOUR PROJECT

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