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.
Kind Regards,
Kind Regards,
Rama Rajesh
Project Manager
Genelife Clinical Research
