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Conducting Randomization in Clinical Trials [VIDEO]

Statistical Consultancy Team

 

When running a clinical trial the industry standard is a double-blind placebo‑controlled parallel group trial. This is because it is the best way to ensure that the characteristics of subjects in each treatment group are the same, whilst ensuring the investigators cannot anticipate the treatment of a subject.

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Topics: Clinical Trials, Statistical Programming, Randomization, Clinical Documents, Serious Adverse Events (SAEs)

How the Hierarchy of Teams Affects the Cost of Clinical Development

Daniel Chapple

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

The location of staff within a functional partnership in clinical development was discussed in a previous blog, but this is closely linked to the experience of staff and where the different levels of experience reside. Having a solution primarily focused around graduates in a low cost area vs. a solution based around experienced team members in a higher cost location can have significant impacts on the cost of clinical development projects. It is likely that any proposed solution will incorporate both sides and understanding the exact make-up of the team will provide some insight into what the Total Value Ownership (TVO) is likely to end up being.
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Topics: Clinical Trials, CRO Selection, Strategic Resourcing, CRO Project, CRO Efficiency, Project Management, Functional Outsourcing, FSP, Total Value Ownership, Outsourcing Solutions

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, Strategic Resourcing, CRO Project, Quality Control, CRO Efficiency, Project Management, Offshore Locations, Functional Outsourcing, FSP, Total Value Ownership, Outsourcing Solutions

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

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

Hitting New Targets - EPC Interview with David Underwood

David Underwood

European Pharmaceutical Contractor held an interview with Quanticate CEO; David Underwood, asking how he started in the pharmaceutical industry, the reasons behind Quanticate's recent success and future trends as well as regulations in the industry.

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Topics: Clinical Trials, CEO's Insight, Visualization, Adaptive Trial Design, Bayesian Methods

14 Advantages of Data Centralization and Standardization in Clinical Trials

Clinical Programming Team

The most crucial element of all research and development in clinical trials is the data.  It is the end product of every experimental and clinical study and supports the label of every product on the market.  It is required for internal decision making, the achievement of regulatory approval, and for monitoring and ensuring the safety of any clinical drug or device in the market. 

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Topics: Clinical Trials, CDISC, Standardization, SDTM, Centralization

10 Considerations of Offshore Locations to Support Clinical Trials

Daniel Chapple

There has been increased interest across the life sciences industry to use lower cost regions such as India, China, Eastern Europe, South America and South Africa to support functions including clinical data management, statistical programming, biostatistics, pharmacovigilance and medical writing within clinical development and safety monitoring areas.

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Topics: Clinical Trials, CRO Selection, Outsourcing Solutions, Offshore Locations

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