Featured Articles
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Handling The Specialized Data Requirements In Oncology Clinical Trials
8/7/2019
The right design and the right data ultimately leads to the right decisions, so obtaining fit-for-purpose data, collected based on what your protocol is looking for is vital. However, there are several data pressure points facing oncology drug developers that need specialized expertise and processes to handle. In this blog, we run through some key aspects to consider to smooth your data collection and analysis.
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Predictive Biomarker Signature Characterization
8/7/2019
A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.
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Innovative Data Science And Real-World Analytics Approaches In Practice
8/7/2019
With the rise in digital technologies, there has been an explosion in volume and type of data sources we can obtain. However, new data sources bring inherent challenges to be overcome including lack of standardization, missing data, and variation in quality. Read how Cytel's data science and real-world evidence groups have helped clients apply advanced analytical techniques to large, complex historical or real-world data sets to improve their decision-making, accelerate development pathways, and enhance their probability of success.
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2018 vs. 2010 FDA Draft Guidance For Industry On Adaptive Designs For Clinical Trials Of Drugs and Biologics
6/13/2019
In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).
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Cytel And Axio Join Forces To Create An Industry Leader In Analytical Solutions For Drug Development
6/4/2019
Cytel Inc., the leading global provider of innovative analytical software and services to the life sciences industry, and Axio Research, a premier provider of biostatistics to pharmaceutical, biotechnology and medical device companies, today announced that they have joined forces to create the largest global biometrics organization focused on delivering advanced analytical solutions for the life sciences industry.
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Opening The Black Box: Moving To Explainable AI
5/24/2019
For the biopharma industries specifically, AI represents an opportunity to avert the R&D productivity crisis with paradigm-shifting applications such as in-silico drug design, prediction of trial risks and big data analytics. However, with every opportunity, there are risks and challenges, and this blog discusses how pharma needs to address the opacity of AI to ensure trust and credibility with all stakeholders.
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Assuring Outsourcing Obligations With Specialist Data Management Oversight
5/24/2019
This blog discusses how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies who may lack their own internal oversight resources.
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Applying Biomarker Driven Strategies In Drug Development
4/16/2019
Determining appropriate stratifications and relevant clinical endpoints for specific sub-populations can be challenging. Therefore, it is necessary for development strategies to incorporate explorations and determinations of suitable biomarkers early in the development of a new therapy.
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Ensuring Robust ePRO Implementation: Factors For Success
4/16/2019
In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial, clinical and technology roles within the biopharmaceutical industry and shares his insights on the primary considerations for sponsors when implementing an ePRO solution.
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Could Adaptive Designs Be The Answer To Oncology Clinical Development Success?
1/31/2019
Across all therapeutic areas, clinical development faces well-documented, critical challenges that impact the pharmaceutical industry's ability to bring new medicines to patients – but in the oncology space, these issues are particularly acute. Read how adaptive trial designs can help address the challenges encountered in anti-cancer clinical development today by saving time, resources and improving the odds of success.