Financial resources for carrying out clinical trials are increasingly limited, however, time-to-market pressure is also growing, and consequently, selecting the appropriate partner is the key to success.
Clinical trials to evaluate the effectiveness of dry eye disease therapy have been always challenging because of the nature of the disease itself, the adequate selection of the therapeutic outcomes and the unavoidable exposure of the ocular surface to diverse environmental conditions.
We have showed that our work-team is able to overcome these clinical trials limitations using state-of-the-art technology (CERLab) and applying our expertise in the field. In fact, a reduced number of recruited patients is sufficient to demonstrate drug efficiency in a Proof-of-Concept trial (Pinto et al. Ophthalmology 2016). This know-how allows companies to reduce execution timelines as well as cost whilst maintaining clinical trial feasibility.
Moreover, our company is able to carry out not only clinical but also pre-clinical high reliable studies. Thus, we can accelerate the drug development process so that the right therapies can be delivered to the right patients. This way will result in better selecting participants when performing the recruitment of the pivotal clinical trial for final drug approval.
Besides, our work-team has participated in over 300 peer reviewed papers and research posters, proving new essential knowledge regarding ocular surface disease research. This expertise will allow companies to adequately spread their study conclusions to the scientific community as well as the regulatory agencies.