Teaming Up for Success: A Clora Case Study

This privately held biopharmaceutical company is developing new therapies for orphan diseases in ophthalmology.

Clora has worked on 9 projects with this company across 4 of its innovative ophthalmic products.

Part 1: Clinical Trial Execution and Regulatory Strategy

As its late-stage clinical development plans continued, the company wanted to do
everything it possibly could to de-risk the execution of their Phase III studies and
overall regulatory strategy. The company had previously used full-service CROs and
had decided to run their clinical trials by utilizing a hybrid outsourcing model due to
quality and budget issues they had encountered.

Clora furnished the company with a small group of experienced operators in
ophthalmology who had previously executed similar Phase III programs with
precision.

The company was able to deploy a team of proven consultants to assist with project
management, site management, and clinical monitoring activities. Additionally, an
experienced regulatory expert assisted with their preparation for regulatory
interactions with FDA and identified potential issues within their NDA
application package.

Part 2: Peri-Approval Activities

The company was preparing to initiate commercial activities following the approval of their NDA. However, it was soon facing CMC challenges with their CDMO while in the midst of relocating their medical device manufacturing facility to support commercialization. In addition to requiring a mock inspection at their new manufacturing facility, they were also in need of software validation audit.

Within days, Clora was able to match the company to seasoned, top-tier consultants with deep experience in ophthalmic drug and device development.

The client was able to handpick a small group of consultants that had previously navigated similar challenges for other companies during the Peri-Approval stage, and deeply understood what needed to be accomplished in order to gain FDA approval.