In our March issue:
FEATURED
Clinical Data Manager: A Future Roadmap
Sony Salzman
With the responsibilities of clinical data managers changing considerably amid the industry’s shift toward more complex protocols and elaborate data-collection standards, experts in the field break down this evolving role—and its importance today in nurturing and empowering the next generation of data scientists and managers.
Solving the Data Scalability Problem
Keith Aumiller
Scalability of clinical trial data structures remains a hurdle for those handling tens, hundreds, or even more studies worth of data. A look at how approaches such as the “apartment” model may help overcome these hurdles by balancing new data science solutions with traditional requirements for data collection and submission.
Unlocking Value from Data Science
Richard Young
To best capitalize on new digital health tools in helping improve data quality issues, there is a need for biopharma sponsors to invest in the data science skills and resources of their data management teams.
Pediatric Trials: Microsampling Case Study
Enaksha Wickremsinhe, Mary Short, Brandon Talkington, Leanne West
Authors present perspectives from youth and parents or caregivers involved in clinical research on the concept of microsampling, or do-it-yourself blood sampling, in pediatric trials.
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NEWS
Eye on Patient Advocacy: Latest column in series explores the importance of site selection through the lens of a Parkinson’s biomarker study.
Washington Report: Jill Wechsler looks at FDA efforts to build on successes in speeding approvals of novel cancer drugs.
EU Report: Peter O’Donnell details the quest by EU specialists to lower the age barrier for enrollment in cancer trials.
Q&A: Drawing from her diverse career path, CRO data science leader shares key learnings on data-based approaches to clinical research.
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CLINICAL TRIAL INSIGHTS
Boosting Vendor Qualification Process
Ken Getz
New study benchmarking the vendor qualification process highlights an area often discounted as simply a cost of doing business but for which there are process improvements and efficiencies to be gained.
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CLOSING THOUGHT
Keeping Pace with Data Management Evolution
Rhona O'Donnell
The latest wave of change to the clinical data management landscape brings with it lingering challenges and new opportunities to transform clinical development.
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lhenderson@mjhlifesciences.com
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