The new realities in biopharma leave less margin for error. Success requires the right partner. With Axzons you can move forward with confidence.
We Reduce Time to Market. AZR has reduced time to market through optimization of all aspects of the clinical trial process and functional areas. We reduce risk through milestone and performance-based agreements to move your product to the next stage towards approval within budget.
Drug development has never faced more challenges: Increasing costs, growing complexity, longer timelines. AZR helps you navigate every step using its systems, processes and expertise.
With offices across the globe, the regulatory affairs team at AZR is an experienced and effective
liaison for the coordination and preparation of complex multi-national submissions with all major regulatory authorities.
AZR provides regulatory consulting as a customized stand-alone service or through our full service clinical trials. Our regulatory professionals ensure client satisfaction through streamlined procedures that provide rapid turnaround of tasks, enabling faster start up and compliance with applicable guidelines.
We can advise sponsors with strategic planning, development, evaluation, and preparation of regulatory submissions at all stages of development and post-marketing. We integrate regulatory and clinical development plans to our sponsor's pipeline strategies by performing regulatory, CMC, audits, and gap assessments to ensure submissions conform to the quality standards of regulatory authorities.
The right EDC system for a study is determined by both project deliverables and budget.
AZR's data management team has experience developing and deploying EDC study systems across several leading vendors including: Phase Forward, Medidata, Datatrials, DataTrak, and Oracle Clinical (paper).