Synchrogenix Guides Company to Transparency and Disclosure Success
In August 2020, an emerging global biotechnology company reached out to Synchrogenix, Certara’s regulatory sciences division, to evaluate the company’s status and strategic direction in global transparency and disclosure activities. The company wanted to confirm compliance to regulations and guidances, and ensure they are meeting industry standards. The company is patient-centric in their approach to research and development of treatments, and are highly interested in patient centricity in transparency and disclosure as well.
Synchrogenix evaluated the company’s existing policies, standard operating procedures, work instructions, and training materials. Synchrogenix subject matter experts interviewed a variety of the company’s senior leaders to gauge their understanding of global transparency and disclosure expectations. Synchrogenix proposed short term, medium term, and long term goals and action steps for the company to reach their desired transparency and disclosure milestones, and helped the company create missing process documents and templates and streamline existing processes.
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Company is a commercial-stage biotechnology company that develops and commercializes molecularly-targeted and immuno-oncology drugs for the treatment of cancer.