Support For Your DSUR Prep

posted on 22nd February 2016 in Data Talk

Anyone who has every worked in supporting a clinical trial, knows that data submissions are nothing short of challenging. As an example, for many years, various countries’ regulatory authorities had different requirements for the content and format of aggregated safety reports. As a result, approximately 4 years ago, the International Conference on Harmonisation (ICH) initiated […]

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eClinical Solutions Achieves Accreditation on Medidata Patient Cloud and Targeted Source Document Verification (TSDV)

posted on 18th February 2016 in News & Events

MANSFIELD, MA – February 18, 2016 – eClinical Solutions, LLC, an industry-leading provider of end-to-end data management services and technologies, announced their latest accreditations to customize and support two additional solutions within the Medidata Clinical Cloud® platform. eClinical has gained accreditation in Medidata’s electronic patient-reported outcomes app (Medidata Patient Cloud ePRO) and targeted SDV technology (Medidata TSDV) in order […]

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Happy New Year!

posted on 29th January 2016 in Data Talk

Happy New Year!  The beginning of a new year never fails to remind me of how overwhelmed I am with digital photos.  The volume of them, their many storage locations, the need to back them up in a timely fashion.  Thinking about my photo files leads me to my music files.  Different files but similar […]

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Our Speedy Brains

posted on 8th January 2016 in Data Talk

Yesterday, in our local library I noticed a new section of books in the children’s area. Ten shelves were filled with books sporting colorful spines, and the sign above them read “Graphic Novels”. When I pointed the area out to my 7- and 11-year old daughters, they went charging over and immediately found a number […]

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Data Visualizations for Star Wars

posted on 4th January 2016 in Data Talk

Like millions of other kids who grew up in the ‘70s and early ‘80s, I share my love of all things Star Wars with my millennial kids. We counted down the days until opening weekend, when we had tickets to see The Force Awakens. While my daughters, son and I prepared to spend the days […]

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Let’s Bring Them Home!

posted on 22nd December 2015 in Data Talk

For the past twelve years, I have volunteered each Christmas to play the role of Santa in the children’s wing of Massachusetts General at their holiday party. Three of us share this role and the instructions we receive from the hospital are to make sure not to promise the patients that anything they ask for […]

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Clinical Data Management from the Ground Up

posted on 17th December 2015 in Data Talk

From both a business and ethical perspective, involving the clinical data management (CDM) team during the beginning stages of drug development has a number of benefits. The core product from any clinical trial is the data you reap from your team’s research. Managing the collection, cleaning and analysis of clinical trial data is quite a […]

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A New Generation of Wearable Devices for Clinical Trials

posted on 3rd December 2015 in Data Talk

Everyone is well aware of the consumer wearable devices such as the Apple Watch, Fitbit and other activity trackers to wear on your wrist. Aside from wristwatches, it’s been hard for wearable devices designed for other parts of the body to gain traction among the public. For example, the once spectacular Google Glass now seems […]

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CDISC International Interchange 2015 in Chicago

posted on 20th November 2015 in Data Talk

This year, the Clinical Data Interchange Standards Consortium (CDISC) celebrated its 15-year anniversary at the International Interchange 2015 event in Chicago! The conference was held last week from November 9 – 13, with the theme, “Smarter Research to Unlock Cures.” At the Interchange this year, there were numerous healthcare-driven presentations and open panel discussions featuring medical […]

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The Impact of Wearable Devices on Clinical Trials

posted on 5th November 2015 in Data Talk

From Google X revealing a smartwatch designed for clinical trial use to the growing number Apple ResearchKit based trials, mobile technology and wearable devices are popular topics of discussion among life science professionals. There’s a prevailing idea that the technology people use every day can be utilized to provide real-world data for researchers and make […]

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