8/1/2013 10:39:46 AM
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Iris Pharma Specializes in Offering Preclinical and Clinical Ophthalmology Research Services Worldwide
(BUSINESS WIRE)-- A leading contract research organization (CRO) dedicated to ophthalmology, Iris Pharma partners with clients to carry out preclinical and clinical studies involving all areas of the field, from the ocular surface – such as dry eye syndrome – to the posterior segment of the eye – including age-related macular degeneration and diabetic retinopathy.
“Our focus in this niche market allows us to guide our clients in making the best decisions to move their products from the laboratory to humans as quickly, safely, and effectively as possible,” says CEO Pierre-Paul Elena, PhD. “From its founding nearly 25 years ago, we have based the company on and expanded our expertise in the science of ophthalmology.”
Clients range from small start-ups to large pharmaceutical companies. Some have years of experience in ophthalmology, and others are new to the field, eager to apply their backgrounds in related disciplines such as diabetes or oncology. Recent clients have also included companies looking to translate drugs developed for use outside the eye to an ocular application, as well as those concerned about possible ocular side effects or toxicity caused by drugs for other uses.
“We are experts in helping our partners from the moment they have a problem or question involving the eye,” Dr. Elena explains.
Iris Pharma has facilitated the translation of more than 40 ocular drugs and medical devices from the laboratory to marketing approval in Europe, the United States, and around the world of by carrying out nearly 2,200 preclinical studies and 100 clinical trials. The company is able to do this as efficiently as possible by maintaining a global view of the ophthalmology drug and device development process.
“We are thinking of humans from the moment we begin testing in animals,” Dr. Elena says.
This CRO offers a complete range of customizable expert services, including:
Performance of GLP preclinical studies, proof of concept, and ocular efficacy studies.
The use of nearly 50 in vivo models – the largest number on the market – to mimic the human eye’s conditions for preclinical studies and in vivo screening.
Development, customization, and validation of drugs and their metabolites in biological matrices through bioanalytical tests, including determining the dosage of very small quantities of product in the microstructures of the eye.
Facilitation and acceleration of Phase I to IV clinical trials and marketing surveys that meet the appropriate regulatory requirements.
Recruitment of patients with appropriate characteristics: more than 24,000 patients and 3,700 clinical sites have been involved throughout Europe and North Africa.
Strategic consulting regarding the direction of drug development, the design of a study, and the best indication for molecules in development.
To support more than 230 clients worldwide, Iris Pharma maintains a GLP-accredited laboratory for preclinical research and bioanalytical testing, and conducts high-quality clinical trials in accordance with ICH GCP guidelines.
“At Iris Pharma, we value customer service, high-quality data, accurate results, and innovative technologies,” Dr. Elena says. “Ultimately, our mission is to advance the field of ophthalmology and to help maintain the eye health of patients, whether it involves ocular-specific drugs or ancillary medical products that may have an impact on the eye.”
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