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

Medication Adherence Every dose, taken regularly at the right time In clinical trials, new drug compounds can fail to demonstrate therapeutic efficacy due to poor medication adherence. In Phase I trials, doses are given in a controlled facility with witnessed mouth-checks. We know the patient took the medication properly because the dosing is observed. However, in…

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GCP Video Series: Audit and Inspection of Clinical Trials

Prepare Clinical Trial Sites for Audit and Inspection When monitoring clinical trials, how do you make sure your sites are ready for audit and inspection?  What can they expect when the inspector arrives?  What if they are unsure how to respond to the questions? What if they don’t agree with the inspection findings? Join Bruno…

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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

Risk Assessment Monitoring Assures Quality Clinical Trial Outcomes When monitoring clinical trials with a risk-based monitoring (RBM) approach, how do you determine Key Performance Indicators (KPIs)? How do you identify where the high-risk areas are? How can you assess them? How can you learn how to evaluate and interpret data? What kinds of things you…

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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

Medidata Talks RBM Big data is being generated by everything around us at all times. Every digital process and social media exchange produces it, including clinical trials. Harnessing the power of big data analytics is the latest advancement in RBM. Barbara’s talk gave practical examples on implementing RBM and extolled the benefits of how all…

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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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