Clinical Trial Technology Editorial
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The Next Three Years Of Clinical Trials: DCTs, RWE, And Beyond
4/18/2022
Recent years have seen unprecedented innovation in the clinical space. Precision medicine, cell and gene therapies, decentralized trials, real-world data, and the promise of artificial intelligence (AI) and machine learning (ML) are just a few of the reasons to be excited about the future of clinical research.
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How To Create An Effective Clinical Supply Visual Dashboard
4/5/2022
It is challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Randomization and trial supply management (RTSM) systems do not encapsulate all the necessary data. It is vital to have an internal central inventory system that maintains oversight of the IP inventory from start to finish and to manage resupplies.
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How Can Pharma Build Trust In Connected Sensors?
3/9/2022
The growth in the use of connected sensors in clinical trials has been nothing short of astounding. An estimated 275 million wearables shipped globally in 2021 and that number is projected to double in the next four to five years. For the use of sensors to continue to grow in clinical trials, pharma will need to develop more trust in them.
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FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations
3/8/2022
Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.
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The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition
3/1/2022
Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.
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Trends In Decentralized Clinical Trial Remote Monitoring For Medication Adherence
2/23/2022
With the implementation of real-time remote monitoring technology, pharmas will be able to do more remote studies that require clinical trial patients to visit sites less frequently. This will remove the burden on patients and improve patient recruitment and retention. This article focuses on the patient medication adherence market.
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Explosive Investment In Virtual Trial Companies: The Latest Data
1/20/2022
This article looks at the blossoming ecosystem and investment growth in the virtual trial space, specifically virtual trial companies that are foregoing the legacy clinical trial models and leveraging new technologies. Further, the article explores the power of the virtual trial platform and the key areas life sciences companies should consider when working with these virtual partners.
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Trends To Watch In 2022: RWD, DCTs, And Cell & Gene Trials
12/16/2021
As we prepare to close out 2021 and look ahead to 2022, it’s a good time to think about the trends that will impact clinical trials in the new year. At this time of year, I receive numerous emails from companies outlining predictions for the coming year from some of their executives. Here are a few I'd like to share.
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Data Interoperability: The First Step To Leverage ML & AI In Clinical Trials
12/9/2021
The first hurdle we need to overcome to leverage machine learning and AI in clinical development is data interoperability. We must break data silos, find a way to make the data points communicate with one another within the drug development continuum, and analyze each data point in its full context. This article also delves into the importance of metadata and the differences between different data formats.
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DiMe Reports Significant Growth In Digital Endpoints
12/9/2021
In October 2019, the Digital Medicine Society (DiMe) launched its crowdsource library of digital endpoints. The library is an open resource that anyone can access. When it launched the library had 34 unique endpoints from 12 sponsor companies. The library has seen significant growth since then. By September 2021 it had 225 unique endpoints from 69 sponsor companies.