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Ben Goldacre Discusses Clinical Data Transparency [Video]

Statistical Consultancy Team

Dr Ben Goldacre, author of 'Bad Pharma' presented a keynote speech at the Clinical Data Live! symposium on clinical data transparency. 

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Electronic Medical Record (EMR), Adverse Events (AEs), Historical Data, European Medicines Agency, Clinical Trial Documentation, Clinical Documents, Ethics, Accessible Data, Data Transparency

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Statistical Consultancy Team

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

Quality Process Improvements and SOP Updates [Infographic]

Quality Assurance Team

This infographic explores Quality Process Improvement and Standard Operating Procedure (SOP) updates from a Clinical Research Organization (CRO) perspective. To confirm compliance to regulatory requirements, processes must be put into place - but how do we ensure our SOPs comply?

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Topics: Quality Assurance, Good Clinical Practice (GCP), Quality Control, Regulatory Requirements, Quality Process Improvement, CRO Efficiency, Standard Operating Procedures (SOP)

Using CDISC SDTM to Improve Cost and Quality in Integrated Summaries

Clinical Programming Team

 

Following on from our previous blog posts on Integrated Summary tips, another aspect that can be considered is the cost and quality of producing integrated summaries and how CDISC and CDASH can aid in reducing costs and improving quality for ISS ISE submissions.

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Topics: Regulatory Requirements, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, ISS/ISE, FDA, Integrated Summaries, Integrated Summary of Safety, Integrated Summary of Efficacy, Standardization

Bayesian Methods and a review of the European Statistical Forum

Statistical Consultancy Team

A member of Quanticate's Statistical Consultancy Team writes about their attentedence and presentation at the European Statistical Forum, Milan Nov, 2011.

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Topics: Regulatory Requirements, Bayesian Statistics, Bayesian Study Design, European Statistical Forum, Bayesian Methods, Survival Analysis, Interim Analysis, Biostatistics Consulting, Clinical Trial Phases

How to Find Traceability Solutions For Your Outsourced Clinical Data

Michael Whitworth

The regulatory importance of knowing where your data are, reproducibility of results.  SI 2004/1031: Schedule 1, Part 2,10: “All clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.”

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), CRO Selection, Clinical Data Storage, Traceability

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