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A Guide to the Benefits of Centralized Clinical Data

Commercial Team

If a pharmaceutical, biotech or medical device company outsources its clinical trials, it may be neither practical nor advisable to use one single Clinical Research Organization (CRO). Smaller CROs may not have the infrastructure to deliver large multinational trials, and large CROs may not offer the level of attention or flexibility required for smaller, but no less important, clinical studies. However, whilst the choice of CRO may be study dependent for the clinical aspects (such as patient recruitment, monitoring, clinical project management and regulatory expertise) there are tangible advantages to centralizing all data handling activities with a single provider – one that supports clinical data management, biostatistics, pharmacovigilance and medical writing services.

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Topics: Clinical Trials, CRO Selection, Clinical Data Storage, Centralization, CRO Project, CRO Efficiency, Clinical Data Services, Functional Outsourcing

Electronic Data Capture Systems In Clinical Data Management: The myths and the reality

Clear Clinica

This post is a guest blog written by David Tashjian from Clear Clinica. The views and opinions in this post are not representative of Quanticate. By publishing Guest blog posts it does not imply Quanticate has a working relationship with any companies associated with a post and we are happy to receive guest blogs from any industry related company.

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Topics: Clinical Data Storage, Case Report Form (CRF), Electronic Data Capture, Phase 3 Studies, Clinical Data Management, Paper-Based Studies

Preparing for Big Data in Pharma

Nick Burch


 

Today, the Pharmaceutical industry, like many, has its feet in both camps when it comes to Big Data. Some parts of the industry, such as genomics and drug discovery, were early adopters and today couldn't imagine life without Big Data technologies and approaches. Others are pushing their current approaches to near their limits, and are beginning to consider "what's next?"

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Topics: Clinical Data Storage, Large Datasets, Big Data

Nick Burch Discusses Big Data in Clinical Trials [Video]

Nick Burch

Nick Burch, CTO at Quanticate discussed Big Data in Clinical Trials at the 4th Annual Clinical Data Integration and Management conference this year in Princeton, NJ. His presentation is titled: 'The Myth of the Big Data Silver Bullet - Why Requirements Still Matter'

Abstract

We've all heard the hype - Big Data will solve all your storage, processing and analytic problems effortlessly! Some moving beyond the buzzwords find things really do work well, but others rapidly run into issues. The difference usually isn't the technologies or the vendors per-se, but their appropriateness to the requirements, which aren't always clear up-front.

Big Data, and the related area of NoSQL, are actually a broad range of technologies, solutions and approaches, with varying levels of overlap. Sadly it's not just enough to pick "a" Big Data solution, it needs to be the right one for your requirements. In this talk, we'll first do a whistle-stop tour of the different broad areas and approaches of the Big Data space. Then, we'll look at how Quanticate selected and built our Big Data platform for clinical data, driven by the needs and requirements. We won't tell you what Big Data platform you yourself need, but instead try to help you with the questions you need to answer to derive your own requirements and approach, from which your successful Big Data in clinical trials solution can emerge!

 

Big Data in Clinical Trials Video 

 

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Topics: Clinical Trials, Clinical Data Storage, FDA, Clinical Study Design, Large Datasets, CRO Efficiency, Visualization, Accessible Data, Mobile Device, Big Data, Drug Development, Technology Trends

Remote Monitoring During Clinical Trials, a Risk Based Approach

Medical Writing Team

 

Within the last few decades the number and complexity of clinical trials has increased considerably, not only across the industry but within individual companies.  With this increase comes the enhanced pressure of effectively monitoring these trials.

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Topics: Regulatory Requirements, Clinical Trials, Good Clinical Practice (GCP), Clinical Data Storage, Case Report Form (CRF), Remote Monitoring, Adverse Events (AEs), Ethics, On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

How Big is Big Data in Clinical Trials – Tall, Grande, Venti Data?

Nick Burch

 

Today, Big Data is one of the hot topics within almost every Industry, especially in clinical trials. May saw the biggest ever European technologists conference on this, Berlin Buzzwords, while the likes of O'Reilly's Strata conference pull in huge numbers of attendees keen to learn how to adapt to this new world.

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Topics: Clinical Trials, Clinical Data Storage, Clinical Study Design, Medical Device, Big Data

How to Deal with Large SAS Datasets in Clinical Trials

Clinical Programming Team

This slideshow focuses on the problems faced when working with large SAS datasets and ways to resolve these problems.

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Topics: Clinical Data Storage, Clinical Programming, SAS Programming, Large Datasets, SAS Datasets

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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