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Eyjafjallajökull volcano in Iceland – Has this volcano affected your clinical trial?

Multinational Clinical Trials vs Mother Nature

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  • 17 May

We all know someone who has been impacted recently by the ash from the Eyjafjallajökull volcano in Iceland.

Source[01]: Wikipedia, photographer: Henrik Thornburn

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Integrating Clinical Trial Data to Bring Products to Market Faster

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  • 14 May
All clinical trial data is digital. We have to submit it to the FDA in a digital manner but it currently gets there in a disparate manner with many systems involved. What is needed to bring products to market faster is what is now known as a "clinical ecosystem." This was something I wrote about before this great term was coined. The concept is that new product development can take place faster through the ongoing integration of electronic data within a clinical ecosystem.
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Time to Take Action and Make Risk-Based Monitoring a Reality

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  • 19 Jan

Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.

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What’s New with CDISC Standards?

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  • 16 Dec

Progress on CDISC Standards has come at a quickened pace in recent years. Helping make advancement of industry-wide standards possible is collaboration among CDISC and other participating organizations (Critical Path Institute, Association of Clinical Research Organizations, Innovative Medicines Initiative, and National Cancer Institute). Joining in the collaboration are regulatory authorities and the pharma industry itself, as well as TransCelerate Biopharma which continues to press forward with its standards initiative.

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Evolution of the Clinical Data Management Role, 1994-2014

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  • 09 Dec

20-Year Retrospective

The role of the Clinical Data Manager (CDM) has changed immensely since 1994, both in terms of role and function. Let's take a fun retrospective look at the great strides made in our field over these last 20 years, and more importantly, where the CDM role is headed. Let's begin with 1994, in honor of the Society of Clinical Data Management (SCDM), which commemorated its 20th Anniversary in 2014.

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3 Reasons to Share Data from Unsuccessful Clinical Trials

3 Reasons to Share Data from Unsuccessful Clinical Trials

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  • 25 Nov

A recent proposal by the U.S. Department of Health and Human Services (HHS) could expand the amount of clinical trial data that drug companies must share with the public. Under the proposal, clinical trial sponsors would be required to report findings for drugs and devices that fail to reach approval.
 

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NJ Statewide Career & Internship Fair is Friday, April 28! Talk w @BioclinicaJobs Proj Mgmt, BD, CDM, IT. Details… https://t.co/27LdT00OEo
bioclinica (5 hours ago)
eHealth Solutions president Mukhtar Ahmed is speaking at #Phorum17 on Apr. 27 https://t.co/OaBPodxZBF https://t.co/VO6GKV0a8v
bioclinica (6 hours ago)
Global Head of Risk-Based Monitoring Kristin Mauri on #RBM essential capabilities. Read the blog here https://t.co/z3yUGZqOzH
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Guest column by Nancy Bradish Myers & Anne McNickle on the White House deregulatory landscape @MedDeviceOnline… https://t.co/LlCJtAPpWz
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Kicking off day 2 Clinical Trial Innov. Summit! Patient recruitment, RBM, technology-enabled #ClinicaTrials r hot t… https://t.co/IoynV539R9
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Join us in Philly nxt wk at #Biomarkers & Immuno #Oncology World Congress! Happy to answer Qs in any of these areas https://t.co/fJ5mVAfQTe
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