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 journal, 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.

In Issue 29 of The Altascientist we explore: 

• Protocol development
• Data management
• Statistical support
• Analysis and reporting

The Clinical Data Interchange Standards Consortium (CDISC) is a worldwide organization for data standardization, ensuring that drug research data delivers the maximum value for sponsors, regulatory agencies, and patients. Data that is accessible, compatible, comparable across regions, and reusable for meta-analysis or reanalysis, serves to improve our understanding of human therapeutics by providing meaningful, efficient research data for the entire global drug research community. Implementing standards to collect, structure, and analyze data makes it easier to aggregate information and take advantage of big data.

In Issue 26 of The Altascientist: 

• Introduction to standardization and its benefits
• Client considerations for nonclinical and clinical data standardization Case Study — Realized Efficiency
• Case Study — Realized Efficiency
• Case Studies — Legacy Data Conversion
• The future of CDISC and data strategy

The quality of study data depends on a rigorous sample management process that safeguards the integrity of samples at every step, from initial specimen collection through bioanalysis, to post-study storage. A CRO partner that conducts both preclinical and clinical studies, and supporting bioanalysis, ensures continuity of processes, knowledge sharing, and a centralized location for long-term storage of all your samples.

Issue 23 of The Altascientist provides a deep dive into: 

• sample collection and storage conditions
• standardized workflows for risk Management and chain of custody
• stability testing
• laboratory management
• customized processes
• management of bioanalytical matrices
• post-study sample management