Complex Ophthalmic device trial

Case Study 5


CHALLENGE/S

A US-based big pharmaceutical company, focused on the development and commercialization of ophthalmic medicines and devices, was in the need of performing a post 510 (k) clearance clinical study to investigate safety & performance of device used for Pars Plana vitrectomy surgery. Based on their previous experiences with some of their previous CRO partners, the company was apprehensive of considering India as a potential trial location.

Study required enrolment of 20 patients from one site having clinical indication for vitrectomy based on a diagnosis of one of the following conditions: vitreoretinal traction, asteroid hyalosis, macular pucker/epiretinal membrane, macular hole, or vitreous hemorrhage within 3 months’ period.

Identified investigator was needed to impart training on the proposed device for vitrectomy before conduct of the study.

OUR STRATEGY

• CBCC identified a renowned Ophthalmologist, with >30 years of clinical practice experience and having network of 70+ hospitals across 11 countries, as the Principal Investigator for the study.

• Selected site with a facility for WET Laboratory, wherein training for vitrectomy with investigational device performed on pig eyes were provided to investigators.

• Trained proctor from EU was invited at the site to train the investigator team on investigational device. We required statutory permission for the proctor visit to ensure the study within 1/3rd of the stipulated time that ensured timely initiation of the study.

• A setup for Audio-Video recording of the surgery was done in order to record all surgeries for future references.

VALUE

With proposed planning and execution strategy, CBCC in consultation with sponsor, managed to train the investigator team on investigational device. We also effectively completed the enrolment of 20 patients (surgery) within one-month. With effective project management, the final CSR was submitted to the sponsor within 2 months of Last Patient Last Visit. Most importantly, we managed to regain the sponsor’s confidence in Indian regulatory system, quality standards and convinced him of India being a preferred clinical trial location.

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