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The Logic of a Clinical Research Organization Programmer

Clinical Programming Team

As a statistical programmer at a leading data focused Clinical Research Organization (CRO), we are requested to become involved with many programming activities on a daily basis, centred around dataset or display generation and quality control (QC). Having the opportunity to develop a process/system which can be used by others is rare. To build any system, a lot of in depth thought is required before any programming begins. We take the requirements and build a robust system to address each potential scenario that may arise, including some which should not.

Within this blog we will explain how statistical programmers can work through a simple request to build a robust system using logic, SAS, UNIX and experience. It will provide a flavour of how robust systems are built and other considerations. 

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Topics: Clinical Programming, SAS Programming, Quality Control, SAS Macros, Quality Process Improvement, SAS

The Challenges of Writing Patient / Safety Narratives

Medical Writing Team

There are a number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects. This blog describes the scope of narrative projects and outlines the associated challenges and provides some ideas to help you successfully manage narrative projects.

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Topics: Case Report Form (CRF), Adverse Events (AEs), Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Serious Adverse Events (SAEs), Patient Narratives, Safety Narratives, Data Clarification Form (DCF), Quality Control

7 Considerations of Global Resources in Clinical Development Partnerships

Daniel Chapple

The second blog post in our “How Total Value Ownership (TVO) can help shape an outsourcing strategy" blog series.

Project costs in clinical development partnerships can be influenced significantly by the location of staff since salary levels differ widely depending on where the staff members are located. The percentage and mix of staff in different locations can provide a cost-effective solution, but it can also provide a solution that compromises quality if the mix is not right. Whilst the initial costs may decrease and help to build a business case, the Total Value Ownership (TVO) may not look so attractive when taking into account the oversight and other costs associated with the deliverables. Any projects that move off their critical paths can also have significant impacts to the overall TVO, particularly if this results in delays of submissions and ultimately launch. 

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Topics: Clinical Trials, CRO Selection, Outsourcing Solutions, Strategic Resourcing, CRO Project, Quality Control, CRO Efficiency, Project Management, Offshore Locations, Functional Outsourcing, FSP, Total Value Ownership

Efficient Data Reviews and Quality in Clinical Trials [Video]

Statistical Consultancy Team

This video is presented by Kelci Miclaus from SAS JMP who was a speaker at Clinical Data Live 2013. Her presentation was is titled: 'Efficient Data Reviews and Quality in Clinical Trials'.

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Topics: Bayesian Statistics, CDISC, FDA, Standardization, Remote Monitoring, Remote Data Capture, Source Data Verification (SDV), Randomization, SAS Programming, On-Site Monitoring, Serious Adverse Events (SAEs), Quality Control, Visualization, Additional Monitoring, Efficient Data Review, Fraud Detection, Patient Safety

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

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