Niche has collaborated with Erytech Pharma SA for several years. Erytech Pharma SA approached Niche as it needed the very best partner to understand the challenges ahead and be pro-active in finding the necessary solutions. The Niche team quickly integrated with the Erytech Pharma SA team, enabling efficient and successful delivery of projects.
The company was challenged with needing to re-visit previously written clinical study reports from historical studies. The existing CSRs were either synoptic or of a very poor quality, far below the requirement for their planned BLA submission. Niche subsequently worked with Erytech Pharma SA on several related regulatory projects. This included re-writing clinical study reports for their pivotal eryaspase trials in various oncological indications. Niche’s involvement went beyond merely writing capability – it involved understanding the bigger picture. Collectively, the Niche team had the experience necessary to envisage the clinical implications of the reported observations when writing and reviewing the study narratives. This experienced proved invaluable in navigating the regulatory pathway.
"In the highly pressurised situation of a start-up biotech with one final shot on goal, it needed the very best team to understand the challenges ahead and to be pro-active in finding the necessary solutions. I did not hesitate to bring in the Niche team at the earliest opportunity. I knew there would be no better group to give us the best chance of success with the BLA submission."
Niche has collaborated with Erytech Pharma SA for several years. Erytech Pharma SA approached Niche as it needed the very best partner to understand the challenges ahead and be pro-active in finding the necessary solutions. The Niche team quickly integrated with the Erytech Pharma SA team, enabling efficient and successful delivery of projects.
The company was challenged with needing to re-visit previously written clinical study reports from historical studies. The existing CSRs were either synoptic or of a very poor quality, far below the requirement for their planned BLA submission. The Niche installed its own delivery mechanisms in terms of its document templates, writing processes and guides, all working under the Erytech Pharma SA quality system. This served to accelerate project delivery.
Niche subsequently worked with Erytech Pharma SA on several related regulatory projects. This included re-writing clinical study reports for their pivotal eryaspase trials in various oncological indications. Niche’s involvement went beyond merely writing capability – it involved understanding the bigger picture. Collectively, the Niche team had the experience necessary to envisage the clinical implications of the reported observations when writing and reviewing the study narratives. This experienced proved invaluable in navigating the regulatory pathway.
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