Medical Writing – Rapid Protocol Development

Pharmaceutical companies are increasingly seeking new avenues to expedite their drug applications. This case study illustrates how an agile approach has enabled a mid-sized pharma customer to meet their business objective, to develop a Real-World Evidence (RWE) protocol, for a rare endocrine disorder requiring delivery in a rapid manner to address the FDA’s feedback. 

Challenge

Our customer needed to respond to the FDA’s comment to expand their product’s label on an urgent basis. The request was to rapidly develop a full protocol for a non-interventional retrospective study. 

Solution

In response to the FDA’s comments and considering the urgency of the proposed observational RWE study, the Catalyst team focused on the delivery of three success factors: quality content, effective communication, agile delivery. 

These factors were achieved through: 

• Effective use of the EnCePP ( European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) checklist to align with global research writing standards
• Streamlined review of supplementary material (study synopsis, study schematic, and SoA (Schedule of Assessments) table
• Rapid resolution of customer concerns with cross functional SMEs within one business day
• Drafting a customized no objection letter requesting a focus on data-privacy and data-governance
• Preparing a draft regulatory compliant protocol, delivered within three days 

Outcome

 The study commenced ahead of schedule because of the rapid protocol realignment to match the expectations of the regulator. The team’s delivery of the revised protocol and accompanying no objection letter was the first of its kind and enabled progression. 

An experienced Medical Writing team providing quality regulatory deliverables gave the customer confidence in Catalyst’s ability to deliver independently and therefore reduce their oversight burden. Further benefits included: 

• This rescue effort resulted in the completion of a regulatory-compliant RWE protocol in just over one month, setting a new benchmark for efficiency in the RWE space
• A streamlined communication plan allowed for the efficient resolution of queries
• Efficient writing methods saved the Project manager and the SMEs a great deal of time