Tailored Medical Writing Solutions for Accelerated Pediatric Research in Infectious Diseases
Background
Our client, a small Swiss-based not-for-profit organization focused on infectious diseases, needed to develop a new Investigator’s Brochure (IB) for a novel combination of previously used antibiotics. They also needed our help to write and QC their full Clinical Study Report (CSR) for a pediatric PK study, originally planned to be submitted as an abbreviated CSR (aCSR).
Challenge
The client required an IB and a CSR for a pediatric pharmacokinetic (PK) study. To develop the IB, our medical writer synthesized information from the Summaries of Product Characteristics (SmPCs) for each existing antibiotic, incorporating new clinical and nonclinical data on the novel antibiotic combination. The source documents were not the standard TLFs and therefore required extensive discussion and interpretation between our medical writers and the client. Initially, the client planned to submit an aCSR, but it soon became clear that a full CSR would be necessary to meet regulatory standards. The CSR needed to be restructured and developed from the ground up without an existing template and with only a partial draft written as an aCSR.
Following the kick-off meeting and starting work on the IB, we realized the amount of work required was higher than initially planned. An amendment was needed to adapt the budget and timelines to the level of work needed for this project. This amendment was drafted, finalized, and signed without causing a delay to the project.
Solution
Morula Health's team of experienced writers delivered a solution that exceeded the client's expectations, combining expertise and seamless teamwork to achieve an exceptional outcome. For the CSR project, we assigned a UK-based medical writer to lead, supported by an experienced Europe-based writer focused on QC. For the IB project, we retained this core team and added a Publishing expert to append all the SmPCs as embedded documents to ensure flawless document submission and compliance with industry standards.
To drive this project’s success, we meticulously selected writers whose skills and backgrounds aligned with the client’s goals and industry demands. Our lead UK-based writer was chosen not only for their leadership and technical expertise but also for their extensive experience working with similar not-for-profit organizations, which enabled them to manage timelines effectively and address project-specific challenges with precision. The second medical writer brought in-depth knowledge of infectious diseases, especially antimicrobial resistance.
Result
Careful pairing ensured a cohesive and efficient workflow, while our consistent use of the same writers for both the IB and CSR projects helped us achieve a 0% medical writer turnover rate. This continuity contributed to a motivated and aligned team, which led to high-quality deliverables and ultimately delighted clients.
With all deliverables completed on time and under budget, Morula Health exceeded expectations, fostering a trusting partnership that has resulted in further projects with this client. The strategic selection of top-tier writers, their industry expertise, and our streamlined, collaborative process proved to be the decisive factors in the project’s success, positioning Morula Health as a trusted partner for future initiatives.
What the client had to say:
"Above all thank you to your medical writer and congratulations for all what you did! It is a real happiness to have this CSR finalized. THANK YOU !!!!"
“The medical writer was excellent, attentive, proactive with good suggestions, met all deadlines, and ultimately delivered a high-quality project”