Genelife Clinical Research has started 12 Phase III Ophthalmology Clinical Trials for DCGI Submission. These 12 studies cover vide range of indications including dry eye, Ocular pain, Intra Ocular pressure, different types of conjunctivitis, pre & post cataract surgery etc. In these studies we are recruiting all kinds of patients from minor to old age people which will be a challenging task for us.
We have already finished selecting sties for these studies. All the sites are selected very carefully as per the current DCGI guidelines including audio visual regulation. All these sites are multi-specialty/government hospitals with DCGI approved ethics committees and are distributed in all Geographical regions of India. During site selection we have considered seasonal variation as well as on recruitment prevalence of the particular ophthalmic condition from DSR, historic data and geographical location.
For adapting and absorbing the complexities aroused due the introduction of audio visual informed consent we have developed our electronic CRF which will be able to capture that also. This will help us to make a complete document for a patient for regulatory purpose and future regulatory audit purpose. During the site selection procedure we have made special emphasis on the infrastructure of site and computational knowledge of site personal.
Like our past studies we are hoping to complete these study before the time we proposed to our Sponsor. Hope we will achieve our target.
Genelife Clinical Research