Patient Data Reporting Featured Articles
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Three Ways To Improve Quality In Clinical Trial Processes
10/24/2017
Timeliness, cost, and quality are all critical factors that must come together to ensure an efficient and successful clinical trial. Unfortunately, the complexity of trials, combined with coordination challenges, force sponsors to have to identify the opportunities needed to improve trials. But how do you know what efforts will produce the best results?
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FDA Issues Draft Guidance On Electronic Records
7/24/2017
The FDA has issued draft guidance for industry titled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.” The draft guidance provides information to sponsors, IRBs, clinical investigators, and CROs on the use of electronic records and signatures in trials.
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Google And Apple Compete For Clinical Trial Supremacy
5/3/2017
The Apple Watch, along with Apple’s ResearchKit, has already found a home in the clinical space. But it just got some competition. In April 2017, we saw the introduction of the Verily Study Watch. If you don’t know, Verily (formerly Google Life Sciences) is the research organization of Alphabet Inc. devoted to the study of life sciences. According to Verily, the Study Watch is the next step in the company’s targeted efforts to create new tools for unobtrusive biosensing.
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Can Better Patient Experiences Lead To Better Medicines?
9/7/2016
When Thomas Goetz co-founded digital health company Iodine, his goal was to show how the patient experience is not just an optional thing to track but a requirement that sponsor companies must understand in today’s information-rich world of medicine. He is now attempting to turn patient experiences into better medicines by combining data and design to help patients locate the best treatments.
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mHealth Panel: Make Progress, Not Excuses
8/30/2016
I recently moderated a couple panel discussions at the 2016 eyeforpharma Data Quality & Technology in Clinical Trials conference in Philadelphia. One of the panels was on the use of mobile and wearable technologies in clinical studies. While many sponsors continue to cite concerns over regulatory issues, other companies are moving forward with their adoption. But what are the main concerns companies face, and how can they be best overcome?
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Data Security In Mobile Health Apps: Does Perception Match Reality?
2/29/2016
The use of mobile apps has exploded in recent years. One report, put out by mobile analytics firm Flurry, shows app usage grew by 76 percent in just 2014 alone. Health and fitness apps were one of the leading categories, showing growth of 89 percent. With the number of apps in the Google Play store exceeding 1.6 million, and the number of app downloads projected to hit 268,692 million in 2017, the use of mobile technologies will not slow anytime soon.
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Why The Cloud Is Set To Ignite A Clinical Trial Revolution
11/25/2015
Clinical research is transforming from a paper-driven model into one that is almost wholly electronic. This goes well beyond the electronic transcribing of data. Wearables and smart phone technology now make it possible to electronically collect data directly from clinical research trial participants, skipping many manual and middle steps.
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Reduce The Cost Of Trials With Effective Innovation And Patient Engagement
7/22/2015
Bringing down the cost of developing a new drug is a challenge to everyone in the life sciences industry. With clinical trials being a huge part of that cost, the challenge is taken seriously by everyone involved in the trial process. Taking a close look at the disruptions that can impact the clinical space would be a good start to determining where sponsors and CROs can be more efficient.
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Innovations Are Ready To Disrupt The Clinical Trial Process
7/20/2015
If we want to bring down the cost of medicines, we need to bring down the cost of clinical trials. If there is one statement that I have heard from more pharma execs than any other, it is that. But Big Pharma can also be reluctant to change, and business as usual will not bring about the changes needed to truly disrupt the process.
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Expert Insight Into ePRO Industry Trends
6/7/2012
As technologically savvy as we think we have become, there are still plenty of studies being conducted via pen and paper. By Rob Wright