Clinical Program Partnering Leads To Regulatory Approval For Retina Drug

A small biotech company partnered with Chiltern to perform full services across over 15 projects for their entire clinical program in retinal indications starting at Phase II.

Over 2,000 subjects were enrolled at 280 sites across North America and Europe.

Numerous requests for subgroup analyses, new analytical approaches and missing data handling conventions required rapid response times..

There were subject recruitment and retention challenges on several protocols due to study design issues, competing trials and long clinic visits with lengthy follow-up periods.