What is Clinical Operations?

What is ClinOps? In Clinical Operations, a clinical project team contributes to and supports a organization’s research and development program in order to advance new investigational drugs/devices to commercialization. ClinOps delivers an inspection-ready dataset and complete documentation of the clinical activities that can support an NDA/PMA. Core Competencies in a Clinical Operations Professional A background…

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Advice for Site Monitor Visits Every Clinical Research Coordinator Should Know

As a clinical study coordinator, what should I do before a Clinical Research Associate (my CRA) arrives for monitoring? Planning Prior to Monitoring Visit (MV) Schedule a mutually convenient date and time to conduct the MV with the CRA, assuring the availability of study team as required Collate the study subject files, Screen Fail subject…

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How to Improve Medication Adherence in Clinical Trials

[box style=”0″] We met the contributors for today’s guest post through their promotion at the DIA 2015 conference and they kindly agreed to provide an article on Medication Adherence. in clinical trials today, a specialized dispensation device called CleverCap has helped some sponsors achieve better medication adherence and compliance mesasurement.The CleverCap helps patients take the right dose,…

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GCP Video Series: Audit and Inspection of Clinical Trials

[box style=”0″] Please subscribe to the Good Clinical Professionals series on our YouTube channel (link).  Daron Scott, Senior Contributor at ClinOps Toolkit will bring you new videos every month.  He is asking hard-hitting questions to find out what it takes to be an extraordinarily effective Good Clinical Professional!  Connect with Daron on Twitter @Scott_Daron In…

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Increase Patient Safety: Quality Clinical Trial Data

Do deep analysis to ensure quality clinical trial data Nancy Isaac joined us for the June 2014 panel discussion of ‘Leveraging Real-Time Reviews: Quality Clinical Trial Data’. In an industry where clinical trial protocols are becoming more complex, it is more critical than ever to leverage real-time reviews of clinical outcome data. Our panel of clinical…

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ClinOps Toolkit Listens. How may we help you?

If you want to help others, you first have to listen I did not listen When I was in preschool, I had difficulty hearing.  At first, nobody realized I was struggling to hear.  I just remember how I felt alone when the children wouldn’t play with me.  Swinging in the school yard, other kids ignored…

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GCP Video Series: Risk Assessment Monitoring

ClinOps Toolkit interview with Penelope Manasco Mana Consulting RBM

[box style=”0″] Please subscribe to the Good Clinical Professionals series on our YouTube channel (link).  Daron Scott, Senior Contributor at ClinOps Toolkit will bring you new videos every month.  He is asking hard-hitting questions to find out what it takes to be an extraordinarily effective Good Clinical Pro!  Connect with Daron on Twitter @Scott_Daron In…

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Secret Formula to be the Best Clinical Trial Site

The Best Clinical Trial Sites are Empowered The best clinical trial sites have laser-focus on the ultimate goal to advance treatment options for their patients. The best sites perform all trial activities and procedures with the highest attention to quality and adherence.  Sponsors will reward for this performance and clamor to work with these sites again…

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Medidata Talks RBM with ClinOps Toolkit for SCOPE2015 Conference

[box style=”0″] Our First Interview in the GCP Series Our 2015 ClinOps Toolkit video interview series introduces you to two of our favorite industry thought leaders and Good Clinical Professionals (GCPs)! Kyle Given and Barbara Elashoff of Medidata kindly agreed to sit down with us for an interview to discuss risk-based monitoring (RBM) and Barbara’s…

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Introducing the GCP Video Series by ClinOps Toolkit

GCP Video Series I am delighted to announce the GCP Video Series by ClinOps Toolkit.  Here, GCP stands for Good Clinical Professionals!  We have filmed two interview style videos already and I have filmed two vlogger style videos.  It has been a lot of fun learning more about this medium for communicating with you all.…

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