Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM & Modern Adaptive Strategies
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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients
At Precision statistical programming, we bring a diversity of experience across therapies, indications, and regulatory submissions. Averaging 10 years of experience, this team collaborates with you at every step to comprehend trial and patient outcomes, ultimately resulting in submission-ready analysis.
Span of services at Precision statistical programming include:
Increasingly, regulatory authorities mandate alignment with CDISC standards for submissions, which greatly expedites the review process. As active contributors to CDISC 360 initiatives, Precision programming teams stay ahead of compliance requirements, making clinical data transformation and submission seamless.
Enterprise-wide data standards strategies that bring together the best of enterprise and CDISC standards, enabling automation and efficiencies in the longer term.
With a track record of converting 60+ legacy studies, the Precision statistical programming team brings a unique combination of automation and expertise to help expedite regulatory submissions.
Benefit from proactive incorporation of changes to CDISC guidelines, that assists our sponsors adhere to pressing regulatory timelines and prevent costly delays.
We have been delighted with the experience level and work product from the entire project team – they feel like an extension of our internal team.
Our partnership with Precision is a true textbook definition of a great collaboration between a sponsor and a CRO.
I recognize that relations between Sponsors and CRO vendors can be strained and difficult, often a blaming game; this has never been my experience with this group as it truly felt like a partnership.
At so many levels, the Precision for Medicine team has been fantastic. I am very grateful for how responsive and how collaborative the whole team is. Very grateful for their help.
Bringing in robust statistical expertise to complete studies supported by Precision for enhanced efficiency and patient outcomes.
Bringing in robust statistical expertise to complete studies supported by Precision for enhanced efficiency and patient outcomes.
Agile and scalable programming teams to augment your internal capabilities and expertise.
Agile and scalable programming teams to augment your internal capabilities and expertise.
Discover how our proprietary technologies, like Clarity and Metavate, are revolutionizing data transformation and generating real-time insights.
Metavate
A unique, automated, data transformation engine built to support any source to any target relational data, MetaVate delivers unmatched efficiencies in statistical programming. Driven by metadata and built on machine learning algorithms, MetaVate can reproduce and automate across studies, delivering expedited standardization and insight generation.
Stay updated with the latest insights in statistical programming and automation through our blog.
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Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to accelerate speed to market. Precision can customize and converge our capabilities to meet your program's unique needs—driving efficiency, agility, and success from start to finish.
Award-winning CRO with deep oncology and rare disease expertise
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Exceptional translational and biomarker sciences with global central lab services
Contact us to learn more about how Precision for Medicine can partner with you to drive efficiencies in clinical development.