Ophthalmology Reading
Center Services

The MERIT Reading Center provides unrivaled independent reading center services built on a four-pillar framework of authoritative medical expertise, advanced FDA 510(k) cleared technology, robust global clinical operations, and our ISO-certified QMS and ISMS.

 

The Reading Center begins with its deep bench of Medical and Scientific Affairs leaders. They direct the activities of a rigorous, dedicated, and quality-focused team that provide masked, independent grading by carefully selected and trained readers as well as data management by highly qualified and experienced data analysts.

 

In addition, the Medical and Scientific Affairs team can offer insights into which combination of morphologic and visual function endpoints will best support a Sponsor’s specific target product profile and market indication.

MERIT’s Ophthalmology Scientific & Medical Affairs Experts

photo of Ronald P Danis
Ronald P Danis, MD, Farvo
Co-Founder & Chief Scientific Officer
Dr. Danis co-founded MERIT’s predecessor EyeKor, Inc. in 2012 with Dr. Huang and Dr. Christopher Murphy, bringing extensive experience as a practicing medical retina specialist to the company. Dr Danis is involved in the design and conduct of many clinical trials, and serves on leadership committees and data safety and monitoring boards for several ongoing studies.
Photo of David Bingaman
David Bingaman, DVM, PhD, D. ACVO
Chief Development Officer
Dr. Bingaman is a clinical vision scientist with over 30 years in ophthalmology and over 25 years of experience and leadership in pharmaceutical and device companies. He has held roles of increasing responsibilities in Strategic, mid-size and start-ups, involving oversight of all development functions and executing ophthalmic clinical trials from FIH studies through global registration trials. Dr. Bingaman also has served as the Chief Development Officer for a global, ophthalmology full-service CRO with world-wide responsibility for regulatory affairs, clinical development, preclinical, and CMC (chemistry, manufacturing, and controls) functions. He holds a PhD in Ocular Angiogenesis and is a board-certified Veterinary Ophthalmologist. Dr. Bingaman works closely with MERIT's Sponsors to advance their clinical programs by matching MERIT’s endpoint offerings with the Sponsors' unique trial designs. He also supports MERIT's senior management team in determining and executing the company’s strategic vision for growth and development in ophthalmology.
Photo of Qienyuan Zhou
Qienyuan Zhou, PhD
VP, Medical & Scientific Affairs
Dr. Zhou oversees the MERIT team of graders and data scientists and analysts, working together with our partners to assist with study design and consultation. Dr. Zhou works extensively with study sponsors and Independent Reading Centers (IRC) to develop imaging protocols and grading forms to meet the specific needs of each trial. Her team is focused on maintaining quality initiatives and providing timely deliverables to ensure the effective execution of clinical trials for our partners.
Photo of Kathleen Zielinski
Kathleen Zielinski, MD
Director of Medical Affairs, Anterior Segment/Safety
Dr. Zielinski is a seasoned comprehensive ophthalmologist with more than 20 years of clinical experience. She provides medical expertise for anterior segment clinical trials, including oversight of safety reviews, and contributes to the development of imaging charters and key study documents—such as PSEPs—to support clear, effective reader training. Dr. Zielinski also works closely with sponsors throughout all phases of clinical research, ensuring the highest standards of data integrity and patient safety are consistently upheld.
Photo of Adaeze Sonuga
Adaeze (Ada) Sonuga, MD
Director of Medical Affairs
Dr. Sonuga has a strong commitment to advancing clinical care through her research in the field of ophthalmology and drug development. She has over 25 years of experience in clinical practice, academia, and clinical research. Dr. Sonuga’s specialization lies in comprehensive ophthalmology, with additional training in medical retina and uveitis. Her research experience extends across ophthalmic diseases including AMD, DR, RVO, IRD, and Non-infectious Uveitis. She’s passionate about advancing clinical care and pursuing improved patient outcomes through the development of innovative treatment options.
Photo of Shawn Wilker
Shawn Wilker, MD
Senior Reader
Dr. Wilker is board-certified in ophthalmology and is a retinal specialist with over 15 years of clinical experience. At MERIT, he supports the development of evaluation procedures for ophthalmic imaging grading. Dr. Wilker’s roles include analyzing and reading images and/or data for ophthalmic clinical trials, performing reading quality control tasks, and developing analysis and reading procedures for ophthalmic clinical trials.
Photo of Peter Nicholas
Peter Nicholas, MD, PhD
Senior Reader
Dr. Nicholas brings over two decades of combined experience in basic research, clinical medicine, clinical research, and industry sponsored research, including medical retina fellowship training, and nearly a decade of CRO experience. He is passionate about bringing the best possible treatments to the ophthalmology clinic. He is focused on delivering quality results to facilitate development of the next generation of safe and effective ophthalmic therapeutics.

The Four Pillars of MERIT’s Reading Center Services

Merit we innovate, we execute, we provide insight, and we standardize
Ophthalmology Reading Center Services

MEDICAL EXPERTISE

With decades of experience and deep knowledge in specific clinical domains, our team provides insight and actionable information in endpoint assessment.

Study Design Insights

  • Protocol design and consultation
  • Reading criteria expertise
  • Integration of published reading criteria with protocol and study needs
  • Early involvement for protocol/imaging design/clinical data collection
  • Advice on clinical endpoints and surrogate endpoints

Masked Image Read & Adjudication

  • Uniform image evaluations across clinical sites by masked, independent readers
  • Minimize inter/intra-reader variability through rigorous reader training, monitoring and oversight.
  • All readers are trained for study-specific reading techniques according to the configuration of the protocol and the expectation of the sponsor.
Ophthalmology Reading Center Analysis
EXCELSIOR by Merit

ACCELERATE YOUR IMAGING TRIALS WITH EXCELSIOR

MERIT’s EXCELSIOR technology platform increases accuracy and efficiency by providing a suite of advanced endpoint analysis tools designed based on our extensive collaboration with biopharma companies.

Comprehensive Cloud-based Software Platform EXCELSIORTM

  • One validated, secured system that contains all study data: images, tasks, queries, site materials, analysis, and read data
  • Cloud-based platform bypasses site IT challenges and effectively manages access rights for sites, sponsors, and readers (zero footprint implementation)
  • Eliminates the question: “Where is our data?” and reduces risk of data delays
  • EXCELSIOR is a 510(k) cleared medical device for ophthalmic and radiological indications that is HIPAA compliant and meets all 21 CFR Part 11 requirements for electronic records and signatures

CLINICAL OPERATIONS

Our project management team provides personalized attention, collaborating closely with our partners to focus on details that drive study milestone achievement and increase site engagement.

Development of Study-Specific Documents

  • Imaging charters
    • Protocol and response-criterion driven, guide all imaging-related activities
  • Site imaging manuals
    • Provide instructions for sites on imaging schedule, image acquisition & upload, answering queries, site support contact info
  • Reading criteria
    • Modified and integrated based on protocol need
  • Data management documents
    • Edit checks, Data Transfer Specification, CDISC standardization

Project and Site Management

  • Risk management through anticipating study challenges
  • Data quality checks to ensure compliance
  • Support ticketing system with <24hr resolution TAT
  • Performance reporting
  • Regular sponsor/site communications

Site Technician and Equipment Certification

  • Detailed user manuals and image acquisition procedures per the protocol
  • Investigator Meeting, in-person or remote
  • Web 1-1 training and instructions to site technicians
  • Site (technician and equipment) certification to ensure readiness for FPI
  • Supplemental performance information of a potential site based on prior experience

Global Reach

  • Images are collected from different sites around the world, standardized, and stored centrally
  • EXCELSIOR delivers seamless image data sharing and evaluation
  • Management of sites with different language requirements
  • Global regulatory and data privacy compliance
development of study-specific documents, project and site management, global reach, site technician and equipment certification

QUALITY ASSURANCE

MERIT delivers standardized processes for site certification, data DICOMization, reader variability monitoring, and data output.

  • MERIT’s Quality Management System (QMS) is ISO 13485 certified
  • We prioritize data privacy; MERIT is GDPR compliant in both our processes and with our proprietary EXCELSIOR™ software
  • EXCELSIOR is a 510(k) cleared medical device for ophthalmic and radiological indications that is HIPAA compliant and meets all 21 CFR Part 11 requirements for electronic records and signatures
  • MERIT’s Information Security Management System (ISMS) is ISO 27001 certified

With MERIT’s Reading Center Services, you benefit from the following:

with Merit's Reading Center Services, you benefit from standardized and accurate processes, minimized bias, collaborative, partnership-driven approach, reduced image acquisition variability among imaging sites, and increased data integrity in collection and interpretation.

Let's Make Your
Project a Reality

Connect with us to learn more about how our expertise and approach can support bringing your product to market on-time and on-budget. Your success is our priority.