The Niche medical writing team was involved in drafting clinical study protocols, providing a succinct but bespoke service to help support efforts in progressing an early-phase clinical program, with a tailored focus on the United States Food and Drug Administration. Niche medical writers also provided writing and editorial services for the creation and publishing of a clinical research manuscript.
The services required were targeted at providing comprehensive clinical study protocols and a manuscript with quick turnaround times to provide a solid framework to kickstart progress on a successful early-phase clinical development pathway. Additional ad hoc work helped bolster the clinical research package.
Following support by the Niche team, Lefamulin the drug for which Niche contributed to the writing of study protocols, saw successful CTA results and has since progressed through the clinical development pathway and was successfully approved by the FDA, EMA and Health Canada. Additionally, the manuscript was published in The Journal of Antimicrobial Chemotherapy.
"I continue to use Niche Science and Technology in my present endeavours, where they work seamlessly with my staff to prepare various clinical study documentation and submissions."
Niche began work with Nabriva in 2010, writing key documents and standard operating procedures for their quality management system. This was followed by providing support in delivering regulatory writing for BC-3205, a novel representative of pleuromutilins, a new class of antibiotics for human use, and BC-3781, a semi-synthetic pleuromutilin. The Niche were involved in wring a series of protocols, CSRs, IMPDs and Investigator Brochure updates. As these assets matured the Niche became involved in writing manuscripts for submissions to scientific journals as well as coordinating the manuscript submissions and responses to reviewers.
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