Central Laboratories Featured Articles
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4 Pitfalls To Avoid When Starting Your AI/ML Journey
2/16/2023
With the transforming artificial intelligence (AI) landscape in conducting clinical trials, it is important your company take action to maximize your returns. Identify a small number of high-impact AI use cases and prioritize these use cases based on feasibility within each department, and avoid these four key pitfalls.
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FDA Seeks Comment On Design And Data Considerations For Externally Controlled Trials For Drugs, Biologics
2/15/2023
On Feb. 1, 2023, the FDA released a new guidance, "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products," for public comment. It provides recommendations to sponsors and investigators, addresses considerations for the design and analysis of such trials, and more. Submit comments to the FDA by May 2, 2023.
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The 5Vs Of Collecting Clinical Data
1/26/2023
Not all data is created equal. Our data strategies need to be commensurate with the risks, complexity, and value of the data collected. If the true value of data is to be realized, it must be collected and captured in accordance with the five “V” dimensions: volume, variety, velocity, veracity, and value.
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Embracing Agility In Phase 2 Clinical Trials
1/19/2023
Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.
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2 Key Areas To Leverage AI/ML For More Successful Clinical Trials
1/3/2023
Artificial intelligence (AI) and machine learning (ML) can be used to minimize errors in clinical trial participant management and streamline data management. However, realizing the full potential of this technology will require overcoming issues such as data quality/access, transparency of development and validation processes, and potential data bias.
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Best Practices For Evaluating The Relevance And Quality Of RWD
12/20/2022
Data scientists from Merck's Real-World Data Analytics and Innovation team share how they applied the Use-case specific Relevance and Quality Assessment (UReQA), a fit-for-purpose RWD quality framework, to assess and select high-quality and relevant data for RWE studies.
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How To Close The Looming Life Sciences Data Storage Gap
12/9/2022
Organizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.
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AstraZeneca Hopes To Advance Oncology RWE
12/6/2022
AstraZeneca is an emerging leader in the chronic lymphocytic leukemia space. It now hopes to develop treatments so patients can avoid chemotherapy, with the hope those therapies will prolong survival in patients while also producing a better quality of life.
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Survey Reveals High Levels Of CTIS Adoption In Europe
11/8/2022
Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.
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RWE & Advanced Diagnostics Propel Better Patient Outcomes
10/28/2022
Notable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.