The Situation

• A clinical-stage biopharmaceutical client requested medical writing services to support a novel treatment for the orphan indication IgA nephropathy 2.5 months before PDUFA.
• The client had a goal of 15 medical information deliverables to be completed before PDUFA.

The Solution

The EVERSANA medical writer successfully developed medical information deliverables from concept all the way through the MLR/MRC process and delivered:

• Eight medical information deliverables approved in 1.5 months
• Additional 7 deliverables approved before 2 months
• FAQs completed before 2.5 months
• All critical (16) MI deliverables completed prior to PDUFA date

The Results

• The client expressed delight and stated that she could not have met her medical information deliverable goal without her medical writer.
• The client also stated that she had to take over the coordinator role in Veeva without having previous Veeva experience and her medical writer walked her through all the Veeva functions and help her be successful in her role.