Central Laboratories Featured Articles
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BIO 2023 Takeaways: AI, Accelerated Approval, Patient Diversity
6/15/2023
On the heels of what felt like the biggest BIO International Convention in years, we’ve compiled a handful of impressions from attendees representing small and mid-size biotech/pharmas, consultancies, and professional organizations.
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FDA Seeks Input On AI Adoption In Drug Development And Manufacture
6/13/2023
The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.
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A Practical Look At Data Governance In The Life Sciences
6/13/2023
Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.
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Tapping Into AI/ML Partnerships To Advance Drug Discovery With Recursion Pharma
6/8/2023
"TechBio" company Recursion Pharma has entered agreements to acquire AI/ML company Cyclica for $40 million and Valence for $47.5 million. To learn about the acquisitions and the future of AI/ML in drug discovery and development, we caught up with Recursion’s CEO Chris Gibson.
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How Do You Determine If RWE Is A Good Fit For Your Org? Ask (And Answer) The Right Questions
6/5/2023
Real world evidence (RWE) is being heralded as a way to enrich our clinical data and lower the barriers to reimbursement. It also carries the potential of reducing the patient burden and lowering the cost of clinical data acquisition. But before getting to the point where we can reap the promises of RWE, we face a number of challenges as an industry.
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Considerations For Compliance With CTIS Submissions Under The EU-CTR
5/31/2023
This article outlines the process for sponsors in transitioning from an EU-CTD to an EU-CTR CTIS submission process. It provides guidance on redacting both personal data and confidential commercial information (CCI) appropriately, with detailed advice on how to identify and assess CCI for redaction, as well as strategies for minimizing the risk.
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From Big Pharma To Nonprofit: 3 Learnings In Building Biostatistics++ Teams
5/19/2023
Biostatistics++ teams involve data management, programming, bioinformatics, epidemiology, and medical writing, and they have a unique position in clinical research and clinical trials. This expert offers advice based on her experience of more than two decades building biostatistics++ teams for Big Pharma, small biotech, and nonprofit orgs.
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Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs)
5/18/2023
When it comes to wading into the muddy waters of a DCT, it's important to specify the risks up front and determine how decentralization is appropriate for each protocol. From a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.
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Patient-Powered AI Is Driving Science And Innovation Forward
5/17/2023
Drug discovery is a game of information: If we understand disease well, we know where to intervene and how to design a molecule to target the disease. AI can be used to integrate the patient experience and voice into solutions, further enhancing their relevance.
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Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials
5/10/2023
The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.