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Case Study: An Advanced Approach to Integrated Summary of Safety Studies
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At Precision for Medicine, excelling in complex submissions is more than our history—it's our promise. Our ISS & ISE solutions are crafted for strategic inquiry, robust integration, and precise execution. Entrust your complex submissions to our capable hands, and experience a smoother, more assured journey towards submission readiness.
Precision is part of our team. They put in long days and hard work to help our study to move forward. We are so appreciative of how fast they worked.
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.
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.
Our partnership with Precision is a true textbook definition of a great collaboration between a sponsor and a CRO.
Unlock the transformative potential of clinical data with MetaVate, Precision’s cutting-edge technology. MetaVate revolutionizes the data landscape for Integrated Summaries of Safety and Efficacy, facilitating seamless integration and alignment critical for these pivotal submissions. This platform goes beyond mere data transformation; it excavates deep insights that bring unmatched clarity and precision to your ISS & ISE documentation.
MetaVate excels in unifying diverse studies and data structures, streamlining even the most complex Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE). Its automation is metadata-driven, compliant with CDISC standards, enabling swift conversion of any clinical data source to regulatory-required formats like SDTM and ADaM. With MetaVate, transform voluminous legacy data into cohesive, submission-ready narratives, enhancing the speed and efficacy of your regulatory journey.
Dive into the latest insights and breakthroughs from Precision's ISS/ISE submissions, alongside a wealth of knowledge spanning the spectrum of global clinical development.
Clinical Trials - Regulatory - Oncology
Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.
Award-winning CRO with deep oncology and rare disease expertise
Exceptional translational and biomarker sciences with global central lab services
Pioneers in planning, building and maintaining manufacturing at scale for pharma and biotechs.
Embark on a seamless submission journey. Learn how Precision for Medicine's ISS & ISE expertise can elevate your regulatory strategy.