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Issue 29 — Data Journey: Building Your Early Phase Clinical Trial Data
In this issue of The Altascientist, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.
Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.
In this issue:
- 0:19 Introduction
- 1:01 Protocol Development
- 2:49 Data Management
- 9:07 Statistical Support
- 10:49 Analysis and Reporting
- 13:28 Conclusion
Click here to download a readable, PDF version of Issue 29: https://www.altasciences.com/sites/default/files/2022-12/The-Altascientist-issue-29-Data-Journey.pdf
About Altasciences:
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
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By The Altascientist
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In this issue of The Altascientist, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.
Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.
In this issue:
- 0:19 Introduction
- 1:01 Protocol Development
- 2:49 Data Management
- 9:07 Statistical Support
- 10:49 Analysis and Reporting
- 13:28 Conclusion
Click here to download a readable, PDF version of Issue 29: https://www.altasciences.com/sites/default/files/2022-12/The-Altascientist-issue-29-Data-Journey.pdf
About Altasciences:
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.