This is Applied Clinical Trials' enewsletter, CRO News, which provides a forum for the industry to discuss the latest alliances, financial information, and business deals and developments, as well as people news.
Outsourcing's Hottest Trends
The August issue of Applied Clinical Trials ended summer with articles about the hottest trends in Outsourcing. The articles related to CROs and Outsourcing include: How We Fail to Use CROs Effectively (And What You Can Do About It); Steps to Functional Service Provider Success; and Outsourcing's Evolution from Commodity to Partner.
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The Dawning of a New Era
DataLabs by ClinPhone is the only true hybrid system, incorporating EDC and Paper Data Management in a single platform. Learn more: [email protected]
Sue Price and Pedro Pala
have both become new members of the team at Penn Pharmaceutical Services. Sue Price will act as head of clinical trial supplies and Pedro Pala will serve as CTS project manager.
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Ronald Kershner
has been appointed by AAIPharma to lead the North American Biostatistics and Data Management Services groups. Kershner brings with him more than 25 years of experience in the industry, including with regulatory submissions and FDA interactions.
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Patrice Hugo
will be the new vice president of scientific affairs at MDS Pharma Services' global central lab network, where he will lead the development of biomarkers from Phases I through IV.
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Christopher H. Cabell
is the new chief medical and scientific officer for Quintiles Transnational Corp. In this position Cabell will be responsible for company initiatives focusing on bioethics and the protection of human subjects.
>>MORE
Kenneth G. Faulkner
will take the position of vice president of medical imaging at Perceptive Informatics, a division of Parexel International. Dr. Faulkner brings with him 22 years of experience in medical imaging.
>>MORE
2nd Annual Conference on Sponsor *Site* Investigator Relationship Management
October 22-23, 2008
Doubletree Guest Suites| Lake Buena Vista, FL
MAGI's Clinical Trial Agreements, Budgets, & Regulatory Conference West
October 12-15, 2008
Venetian Congress Center and Palazzo Hotel| Las Vegas, NV
2008 Clinical Outsourcing Leaders Summit
November 13 , 2008
Washington, DC
ProTrials announced it has made the list of Top 10 Women-Owned Businesses in Silicon Valley.
While Covance acquired some of Lilly's drug development business (see left), the pharmaceutical company also transferred its U.S. and Puerto Rico-based clinical trial monitoring work to Quintiles. Its U.S. data management work will go to i3 Statprobe.
For CROs still using static databases for site selection, Health Market Science is offering its Clinical Investigators online tool to increase insight into the potential patient pool. Read the release here, and read our September print issue for an indepth news article.
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Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
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