An intelligent approach to data cleaning 

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The collection of good quality data from clinical trials is essential to data analysis to produce robust results that meet the precise requirements for regulatory need. Data from clinical trials are increasingly complex, related to involved protocols, the geography of trial sites, increasing data streams and technological advances. Therefore, studies must be set up to be efficient, offer support and training to trial sites and ensure that the right data are collected correctly.

Data Management teams have historically reviewed data once source document verification (SDV) has taken place by the Clinical Monitors on an ongoing basis. Data issues can be actioned early in the trial, and corrective action put in place. This activity has been a very manual process, thorough and time-consuming and has left less time to focus on insightful data analysis.

Collaboration: Data science and da…
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Key clinical trial considerations for the new normal and the future

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A great many new and varied approaches to clinical trial management have gained ground during the COVID-19 pandemic through the help of virtualization tools, strong partnerships, and regulatory guidance. Despite the upheaval this year and last, there appears to be a silver lining. The systemic changes have enabled remarkably quick development in adapting trials to accommodate different environments. Additionally, the pharma industry has developed COVID-19 vaccines at an incredible speed. Regulatory guidance has accommodated this abrupt shift. This article will cover the critical factors needed before adapting to patient-centric clinical trials.

For starters, there are quite a few differences regarding attaining and disseminating patient-level data in a decentralized or remote trial setting versus the traditional way an in-person study is designed. Telemedicine or remote visits, for …

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Q&A: Keys to unlock data science potential for drug discovery

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For all of its promise in healthcare and elsewhere, deploying artificial intelligence is frequently a challenging endeavor. “Close collaboration between data science teams, other project team members and stakeholders is essential,” said Jennifer Bradford, director of data science at Phastar, the London-headquartered contract research organization. While input from computational, statistical or medical experts could be essential to inform data science models, all stakeholders understand the requirements and are working “in sync with the project,” Branford said.

In the following interview, Bradford shares advice on how to collaborate effectively on data science projects, the impact of COVID-19 on data science in pharma and the potential for AI to accelerate R&D timelines. 

What comes next after alignment between different stakeholders on data science projects is confirmed? <…

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How to make COVID-19 clinical trial statistics meaningful to the public

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COVID-19 has brought a newly heightened awareness of the need to better understand clinical trial statistics and their direct impact on the public. I cannot remember when statistical data was more in the limelight than now. The pandemic’s first wave put many countries into lockdown. All governments and their local representatives delivered press conferences regularly to update the masses on the newest statistics and safety precautions. There were statistics on how many people caught the disease, how many deaths, how many ICU beds were still available, and just about every interesting statistic you could think of related to the pandemic. 

Data collected from the COVID-19 pandemic continues to be used to inform decisions and make future projections related to drug development and beyond. Individuals are also using pandemic statistics to decide how to live th…

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Phastar wins investment from Charterhouse Capital Partners

The contract research organization Phastar (London) plans to expand its statistics and data science services with funding from Charterhouse Capital Partners, a European private equity firm. Phastar will also use the funds to expand its international footprint, opening an office in China.

“We continue to see strong growth across pharma and biotech services,” said Kevin Kane, CEO of Phastar over email. “Pharma companies are looking to specialist suppliers with experienced staff to provide functional service provision (FSP) services as the larger full-service CROs fail to deliver on quality, and biotechs continue to need strong statistical and data science support for their drug development projects, recognizing that experts in these areas can design better trial programs with fewer patients.

The company already had operations in the U.S., U.K, continental Europe, Africa, Japan and Australia. Last year, the firm opened offices in San Diego and To…

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