Showing results 657 - 672 of 91813 for .
Showing results 657 - 672 of 91813 for .
Target Launch Date: July 18 Validation: A Key Stage in Mobile Health Development
To enter the rapidly growing mobile health space, companies must overcome the crucial hurdle of validation. This process demonstrates that the app - in combination with the underlying technology platform / device - performs comparably to traditional products on the market, ensuring that patients and providers can rely on the output to make appropriate medical decisions.
The Development Landscape for Non-Alcoholic Steatohepatitis
Q with Claudia Filozof, MD, PhD, Senior Medical Director in the Phase II-IV Cardiovascular/Metabolic Group and Richard Williams, PhD, JD, Executive Strategist, Global Regulatory Affairs
New FDA Labeling Regulations are Here - Are you Prepared?
The new FDA regulations for the Nutrition Facts labels and Supplement Facts labels went into effect this month. With a refreshed design reflecting updated information about nutrition science, the new label is intended to better inform consumers about their choices.
Understanding 505(b)(2): An Abbreviated Pathway for Modified Drugs
Among the regulatory pathways for small molecule drugs in the United States, the 505(b)(2) option occupies a middle ground. Intended for modifications of an existing treatment, it requires much more evidence than a generic but allows the sponsor to use data from a previous application. Companies can thus avoid unnecessarily repeating studies and shorten their development time.
Behind the Scenes with Kits & Logistics for Vaccine Studies
Whether large or small, vaccine studies differ from standard drug development in many ways. Sarah Slette, Sr. Study Manager, Vaccines & Novel Immunotherapeutics at Covance, explains the unique challenges her team faces and their solutions to rapidly deliver customized vaccine kits to sponsors' sites across the globe.
The Next Frontier for Cancer Immunotherapy Trials
With its measurable impact on patient survival, there's no denying that immunotherapy is already causing momentum in ways that cancer is treated. Drug researchers and developers are identifying new candidates in their growing pipelines and exploring combinations of immunotherapies, while regulatory agencies are providing expedited review and approval of these therapies for new indications at an unprecedented rate.
An Insider's View on Working for Covance
Since starting my drug development journey as quality assurance manager in a laboratory that would later become part of Covance to now serving as the CEO, I've witnessed our industry's notable shift to support more nimble drug development.
Novel Assays Support RSV Drug and Vaccine Development
Chances are you've been hit by the respiratory syncytial virus (RSV), which infects nearly everyone by the age of 2 and usually reinfects exposed people throughout their lifetimes. While most healthy people experience mild to moderate cold-like symptoms, RSV can also cause severe infections.
Shape New Career Possibilities at Covance
With unique career opportunities to advance the future of drug development, Covance employees are part of an exciting journey, delivering novel and comprehensive solutions to advance medicines from early research to clinical trials and beyond.
The Importance of Stakeholder Research in Rare Disease Drug Development
The approval of novel orphan drug designations continues to grow, while many existing rare disease therapies are receiving approval for expanded indications. With this increase and broadening class of products, including some that target the same mutation or molecular defect, sponsors face new and significant market access challenges in securing reimbursement.
Risk-Based Monitoring - Driving the Evolution of the Clinical Research Associate Role
Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines.
Keeping Skills Sharp For CRAs
The drug industry is evolving and clinical trials are becoming more complex. How do CRAs in a large global company keep their skills up to date? Recognizing that large group meetings are costly and virtual training feels impersonal, Covance decided to address this challenge with an innovative model called CLIK: Country Leadership Imparting Knowledge.
Strategic Alliance with Global Specimen Solutions: Introducing Covance SpecimINSIGHT™
The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information - such as genomic profiles - have become critical to submissions for drug approval. Against this dynamic backdrop the to central challenge facing trial sponsors remains the same: the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Computerworld Names Dimitris Agrafiotis of Covance a 2017 Premier 100 Technology Leader
Agrafiotis' Leadership in Bringing Xcellerate® Informatics to Market Demonstrates How Software Can Improve Health and Improve Lives
Fierce Innovation Awards Recognize Xcellerate® Trial Design As Best Data Analytics/Business Intelligence Technology
Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry.
Important Early Considerations For Assessing Drug Abuse Liability
Assessment of abuse potential of compounds in development is one of the most complex regulatory requirements and constitutes a critical exercise for sponsors and regulators. The strategy for the assessment of abuse potential cannot be customized and requires individual evaluation of the compound, its target indication and the entirety of the nonclinical and clinical safety database. In July 2016, the United States Congress passed the Comprehensive Addiction and Recovery Act (CARA) bill to...