Clinical Research

Ora regularly conducts Phase I-IV, Pharmacokinetic, Safety, and Bioequivalence studies. Our clinical research staff includes over 100 full- and part-time research professionals, including physicians, Ph.D.'s, optometrists, nurses and regulatory professionals.

We conduct all trials in accordance with Good Clinical Practice (GCP) guidelines. Our staff participates in ongoing training programs regarding FDA/ICH/GCP guidelines, basic and clinical science, and internal Standard Operating Procedures (SOPs).

We also work in conjunction with Andover Eye Associates, a leading multi-specialty eye care practice built by Ora’s founder, Dr. Mark B. Abelson. Ora, Inc. maintains large databases of active local research subjects for participation in clinical research at our Andover, Massachusetts facilities.

Over the past 30 years, Ora has developed a number of revolutionary clinical research models. They include the Conjunctival Allergen Challenge Model (CAC™), our controlled clinical model for evaluating anti-allergy therapies, and the Controlled Adverse Environment (CAE), used in the evaluation of dry eye therapies.

In addition, Ora has accrued decades of experience in contract monitoring on projects including allergic conjunctivitis, dry eye, glaucoma, surgical protocols, and marketing studies. We are able to monitor under Ora-approved SOPs, or we will use a client’s SOPs if the client prefers. For all trials that we manage, we design and print source documentation and case report forms, and we prepare regulatory binders for all sites.