How We Will Help You

With over 40 years of company expertise in ophthalmic clinical research, Ora is your ophthalmic CRO partner from early engagement through clinical trial execution.

Early engagement with Ora identifies the best path forward for your ophthalmic candidate.

  • We offer our expertise in clinical development strategy, working with you to evaluate the optimal clinical indication for your product based on mechanism of action, unmet medical needs, competitive market, regulatory pathway, and overall likelihood of success.
  • Once an indication is selected, we will collaborate with you to design a clinical development plan and draft protocols that will optimally evaluate your product.
  • We tailor study design and patients to your MOA, enhancing the likelihood of success in the shortest time possible. We can be your guide at any stage of clinical development, and help you choose from conventional environmental study designs, enhanced environmental studies, disease-specific models.
  • Our collective early engagement efforts are founded by a deep understanding of regulatory requirements continually reaffirmed by monthly interactions with the major regulatory agencies (FDA, EMA, and PMDA) on behalf of our clients.

Ora provides the expertise and capabilities you need as your full-service retina CRO

  • The personal and long-term relationships we have with all our sites, over 200 across North America and over 100 across Europe, maximize the success of the collaboration.
  • We have dedicated and project managers and clinical research associates with expertise in ocular allergy studies.
  • Unique operational standards result in the shortest timelines and least number of sites of any multi-centered clinical trial in allergic conjunctivitis.  By minimizing variability in your dataset, we provide you with a more rapid and predictive response to your clinical questions.
  • We have long-standing partnerships with Reading Centers for collection and assessment of the highest quality imaging endpoints and with which we design and customize imaging endpoints based on the mechanism of action and targeted patient population.
  • We perform quality assurance certification of manifest refraction and best corrected visual acuity lanes in all sites.
  • To demonstrate efficacy of your ophthalmic candidate, a study design known to be accepted by regulatory agencies worldwide will provide the confidence you need in moving forward into the clinic. We utilize validated sign and symptom scales for endpoint assessments required in these studies.
  • We perform quality assurance certification of manifest refraction and best corrected visual acuity lanes in all sites.

Tighten Your Dataset by Minimizing Variability

Ocular disease is wrought with internal and external sources of variability that weaken the power of your data. We eliminate these sources of variability by:

  • Recruitment of patients from our large databases of patients across the country
  • Enrollment of patients in groups so that trials can be executed in a single season
  • Unique operational management with feet-on-the-ground teams of clinical research associates, maximizing adherence to protocols and standardizing data collection across sites
  • Implementation of validated grading scales that are uniquely reflective of allergic signs and symptoms
  • Use of models that helps standardize endpoints, patient selection, and control for environmental factors that exacerbate disease.

Screening and Diagnosis

Significant improvements in imaging technology and diagnostic markers demand a fluid partnership of drug and device development programs.
We have long-standing relationships with the ophthalmic Med Tech industry, as well as significant experience in filing for novel products in ophthalmic imaging, telemedicine, and biomarker assays for diagnostics.

Let’s start the conversation about how we can help you with your ophthalmic candidate.

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