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Showing results 1249 - 1264 of 91813 for .

Showing results 1249 - 1264 of 91813 for .

NASH: Key Considerations for Drug Development
NASH drug development presents distinct challenges, including the usage of surrogate endpoints, with later studies required to confirm clinical benefit and liver outcomes.
Viral Safety Testing Using an Advanced Next Generation Sequencing and Bioinformatics Platform
Viral Safety Testing Using an Advanced Next Generation Sequencing and Bioinformatics Platform
Keeping Risk In Proportion
Learn about the importance of adopting a risk-based approach to clinical trials.
Implementing a Proactive Approach to Risk Management
Sponsors running clinical research studies confront enormous pressures today. From complex study designs, industry cost constraints, new geographical locations and significant technological advancements, there are many challenges to face. The International Council for Harmonization (ICH) efficacy guideline on Good Clinical Practice (GCP) aims to help sponsors keep up with these major shifts and implement improved practices in the industry. This article discusses how the ICH has changed with...
The Role of Real-World Evidence in Supporting a Product's Value Story
Planning carefully throughout the product's lifecycle is key to generating effective evidence that supports a product's value story. Learn more about how a real-world evidence strategy, implementation and ongoing re-evaluation is needed for maximized product success.
Risk-Based Analysis of Chemical Hazards
Addressing the FDA rule on Preventive Controls for Human Food which requires food companies to develop a written food safety plan including a hazard analysis and risk-based preventive controls on known or reasonable foreseeable hazards that could affect food manufactured, processed, packed or held at a facility.
Transforming Risks into Results with Xcellerate® Monitoring
Discover how a strategic approach to clinical trial monitoring with Xcellerate® Monitoring can deliver greater improvements in data quality, patient safety and cost efficiency across the clinical research industry.
SEND - What to Expect
The Standard for the Exchange of Nonclinical Data (SEND) is the FDA's new nonclinical submission requirement that goes into effect in December of 2016. The webinar guides you, step by step, through a practical and proactive look at using a SEND dataset and walking through a typical SEND experience: receiving a file, opening and viewing your dataset and saving to spreadsheet format. Also discussed are the domains of a SEND dataset and the ways that the FDA may view your data, along with...
The Role of a CRO in Immuno-Oncology Studies - Summary
Watch this summary video to see the recap of the Role of a CRO in Immuno-Oncology video series.
Diabetic Nephropathy Webinar
Diabetes and hypertension frequently coexist and account for much of the increased global burden of kidney disease. There are multiple drugs in development to reduce progression of diabetic nephropathy, but there are well-recognized challenges associated with conduct of later phase clinical trials in diabetic patients with kidney disease. To optimize clinical trial performance and maintain patient safety, sponsors are increasingly taking advantage of advanced informatics tools. Join this...
The Role of a CRO in Immuno-Oncology Studies - Genomics Biomarkers
Watch this video to learn about genomic biomarkers in immuno-oncology drug development.
WEBINAR: Kidney Biomarkers in Drug Development
Key Learning Objectives: • Introduce translational novel biomarkers to bridge nonclinical studies and human patients • Provide an overview of successful translational biomarkers • Provide insight into evaluation of nonclinical urine biomarker data • Discuss translational biomarkers in clinical trials for recent renal-related diseases/mechanisms
In About 60 Seconds: Meet Carrie Ferstl
In About 60 seconds: Meet Carrie Ferstl, PH.D, Senior Technical Manager, Covance
Xcellerate® Trial Management Demo Video-Japanese Subtitles
See how you can unite data systems to view, track and report performance metrics across countries, studies and sites in near real time with Xcellerate® Trial Management.
Rare & Orphan Disease Patient Perceptions: Implications for recruitment, retention and compliance in clinical trials
Do you face the challenge of recruiting and retaining rare disease patients for orphan drug clinical trials? Now, discover how you can boost participation, enhance outcomes and speed drug development in this competitive market. Join Dr. Rolando Gutierrez-Esteinou, MD, Vice President, Therapeutic Area Head, Neuroscience Medical and Scientific Services at Covance, for this timely webinar. Gain game-changing insights as we: Identify key aspects of rare disease patients' mindset and views on...