In the past two decades, regulators have placed increasing emphasis on submitting standardized data. In an age where investments in clinical development continue to climb, it is important to understand how an effective data standards strategy can meet these regulatory requirements while also helping biopharma companies improve efficiencies, and thus maximize returns on the R&D investment.
The adoption of data standards by small to mid-sized biotech companies is often deferred since implementing, building, and maintaining libraries can be a costly affair. However, this lack of initial investment in data standardization typically hits companies at the end of the development journey, when clinical data has been handled by various CRO and technology partners, thus making managing, cleaning, and analysis during submission stressful and resource intensive.
There is no one size fits all solution, but there is a solution for everyone. The key to success lies in aligning to long-term goals and implementing standardization in phases.
Register for this webinar to learn how a proactive data standards strategy can be crafted and effectively implemented, thus ensuring submission readiness while optimizing resources. Once standards are implemented, the options for automation are almost limitless, thus building efficiency and quality into processes.
Session details:
Date: Thursday, 06 Oct 2022
Time: 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
Duration: 1 hour
Speakers:
- Jason Housley, Head, Global Clinical Data Standards and Automation, Novartis
- Nithiya Ananthakrishnan, Founder and CEO, Algorics Inc.
Link to register: https://xtalks.com/webinars/a-proactive-data-standards-strategy-to-maximize-biopharma-rd-assets/
For any queries, please reach out to us at hello@algorics.com