StudyOrganizer – Your Complimentary Study Management Assistant

31 08, 2015

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?

2021-05-19T13:30:14-04:00

On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines.  The addenda feature important changes affecting investigator oversight, document processes, monitoring plans, and validation (the changes will not be final until November of 2016).  Each of these pulls the tide towards further electronic management of clinical trials. With [...]

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?2021-05-19T13:30:14-04:00
3 08, 2015

Opposing Views on FDA Complete Response Letters

2021-05-19T13:13:10-04:00

Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved [...]

Opposing Views on FDA Complete Response Letters2021-05-19T13:13:10-04:00
3 03, 2015

Integration Gets Pushed Off Again

2020-08-25T16:04:52-04:00

HL7, CDA, FHIR, CDISC, CDASH. The word jumble surfaces when researchers attempt to integrate clinical data with trial data. It also illustrates a trend where technologists, not clinicians, have control of patents' information. We propose there’s another way — an approach that puts the clinician in control of data movement. First let’s look at [...]

Integration Gets Pushed Off Again2020-08-25T16:04:52-04:00
15 01, 2015

Do good, feel good: make software that matters

2021-05-19T12:29:14-04:00

Today, the largest technology companies in the world create social connections, organize the world’s information, and build great devices. These have a massive impact on society. According to McKinsey, social media’s impact is estimated to top $1.3 trillion annually. That’s a big number, and if you’re a software developer, its one that will get you featured on Techcrunch, and get you lauded [...]

Do good, feel good: make software that matters2021-05-19T12:29:14-04:00
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