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Showing results 97 - 112 of 399 for .

Showing results 97 - 112 of 399 for .

Rare Disease Drug Development Solutions
Rare Disease Drug Development Solutions
SEND Solutions. Efficient. Enlightening.
The Standard for the Exchange of Nonclinical Data (SEND) is the new FDA electronic, standardized format for submitting your nonclinical study data with increased efficiency. Plus, it's so much more. SEND delivers an enlightening new view of your nonclinical study data that enables you to gain fresh insights and a valuable research database while complying with the FDA regulations.
Xcellerate® Clinical Data Hub
As a novel solution to aggregate data within and across multiple trials, Xcellerate Clinical Data Hub helps standardize current operational and clinical data that feed into the Xcellerate Informatics Suite.
Xcellerate® Data Review
Xcellerate Data Review allows data managers to detect instances and sources of missing data, high query rates, delayed data entry and other data quality issues that impact trial data integrity.
Xcellerate® Insights
Xcellerate Insights provides a single-entry portal that enables teams to stay focused on study performance.
Xcellerate® Monitoring
Leverage near real-time data with risk-based, adaptive site monitoring to identify issues and trigger targeted actions that proactively mitigate threats to a clinical trial's success.
Discover How Our York, UK CMC Analytical Testing Lab Can Help Advance Your Drug Development Program
With more than 35 years of industry experience, deep scientific expertise and expanded global operations, investing in innovative facilities that support safety and quality is one way we demonstrate our commitment to you.
Antibody-Drug Conjugates CMC Analytical Solutions
Increasingly, regulatory agencies encourage management of the product lifecycle as an element of the new Quality Paradigm outlined in the ICH Q8/Q9/Q10/Q11 Harmonized Guidelines. Whether you employ the minimalist approach or an enhanced Quality by Design (QBD) approach, Covance can help you make better choices of how you manage and what you spend to support the product lifecycle. Your path to achieving this is the Covance Central CMC Analytical Solution.
Monoclonal Antibodies CMC Analytical Solutions
Reaching development milestones faster and effectively managing your program from discovery to post-launch requires specialized expertise and end-to-end solutions. Whether your ultimate objective is regulatory filing, commercial release or managing the product lifecycle, we'll help you to make smarter decisions faster.
Vaccines CMC Analytical Solutions
By choosing Covance as a single, centralized CMC analytical laboratory, you can obtain higher quality analytical data more efficiently and at lower cost/fewer resources than by working with multiple providers/CMOs. This analytical data is the key to knowledge and quality risk management throughout the product lifecycle.
Challenges and Solutions in Immune-Mediated Inflammatory Disease Trials
This white paper provides an overview of the Covance solutions for challenges commonly encountered by drug developers in the IMID field.
Immuno-Oncology Survival Modeling
To understand the methodological approaches, we have reviewed the majority of the IO therapy submissions to NICE from 2011 to 2018. Through this we have been able to identify the common methods used and consider what the impact of long-term uncertainties in clinical and economic outcomes might be on reimbursement and access. We briefly outline how these uncertainties can feed into discussions on managed entry agreements (MEA) and access to IO drugs at a national level.
The Integrated Early Drug Development Platform
Is it possible to deal with the explosion of complexity in the early clinical development space? Is the traditional clinical pharmacology unit obsolete? The answers are yes and no, respectively. The optimal engine for early clinical development in the modern era is an integrated early drug development platform.
Receptor Occupancy by Flow Cytometry
For preclinical and clinical study design, determining the optimal drug dosage is critical. Receptor occupancy (RO) models are used to understand a drug's behavior and determine safe drug dosage levels. Learn how flow cytometry can help inform decision points in nonclinical and clinical development.
Designing a Comprehensive Self-Administration Drug Abuse Liability Study | Part 2
Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug's abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team at Covance designs and setup accurate and valid nonclinical GLP abuse liability assessment study types required by regulatory agencies: self-administration, drug discrimination and physical dependency studies.