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Services

Our expertise spans every stage of the drug and device development and marketing process, from concept to consumer.

Consulting

Ora can consult with a client on many different levels including: pipeline development, venture capital, interfacing and clinical trial design, regulatory interfacing, and marketing message development. By having experts in the field of clinical research on your side through every phase of the drug development process, you are providing your product the best chance possible for approval.

Clinical Consulting

Ora has extensive experience in contract monitoring on projects including allergic conjunctivitis, dry eye, glaucoma, surgical protocols, and marketing studies. The group is able to monitor under Ora SOPs, or can use client SOPs if the client prefers. For the trials Ora manages, we can design and print source documentation and case report forms and prepare regulatory binders for all sites.

Regulatory Consulting

Involved in regulatory affairs for over 30 years, Ora interfaces with the FDA regularly and prepares clinical-regulatory strategies with clients. We pride ourselves on innovative, efficient, methods for looking at therapeutics while maintaining focus on the objective- timely marketing approval. We have worked closely with divisions at the FDA for drugs, biologics, and devices, as well as DDMAC/FTC, and the EMEA in Europe.

Ora will work with clients in the development of pre-IND strategies, preparation and submission of pre-IND packages, Investigational New Drug Applications (INDs), and New Drug Applications (NDAs) and can work in preparing the entire document, or will prepare specific sections as requested by the client. All INDs prepared and submitted by Ora to date have passed the 30 day wait without clinical hold. Ora has also prepared 510(k)'s and Investigational Device Exemption (IDE) applications. Mark Abelson, M.D. and the Ora team frequently accompany clients to the FDA to present plans and data. Ora has also designed risk management programs for large companies and start-ups and has interfaced with the FDA compliance offices on a number of issues related to potential recalls for their clients.