Industry news focusing on the people and organizations who work in the clinical trials profession.
• Catalent Pharma Solutions (Somerset, NJ) has made two new additions to its team with the appointments of Lois Johnson as Vice President of Quality, Development, and Clinical Services, and Alex Eslava as Vice President of Quality, Sterile Technologies.
Lois Johnson
• Bringing with him more than 13 years of pharmaceutical, commercial, and risk management experience, Frank Gallo was appointed Executive Director of Risk Management by PPD (Wilmington, NC).
• A QPS (Newark, DE) employee since 2002, Eric G. Solon, PhD, has a new role as Fellow, Autoradiography DMPK.
• Using her 13 years of quality assurance experience, Rose Buot will be Clearstone Central Laboratories' (Toronto, Canada) new Vice President of Global Quality Assurance.
Rose Buot
• CNS Network (Los Angeles, CA) has formed a partnership with Logos Technologies (Arlington, VA) to use Logos' early phase, e-source data capture system and site automation tools, ALPHADAS.
• Hitachi (Tokyo, Japan) and NextDocs (King of Prussia, PA) have formed an agreement in document management solutions for pharmaceutical manufacturers.
• By forming a strategic partnership with endpoint (San Francisco, CA), which develops Interactive Response Technology (IVR/IWR) platforms, Chiltern (London, UK) becomes a minority shareholder in the company.
Frank Gallo
• To facilitate the development of promising therapeutic medicines, Eli Lilly (Indianapolis, IN) has joined SNM's (Reston, VA) Clinical Trials Network.
• In order to accelerate development of a new class of antibiotics targeting drug-resistant "superbugs," Phico Therapeutics (Cambridge, UK) has raised a further €1.8 million.
• Aureus Pharma (Paris, France) is participating in a €118.2 million project, the Biointelligence R&D program, designed to promote the use of systemic modeling and simulation tools to exploit biomedical databases to improve research efficiency.
• Integrated Clinical Trial Services (Cary, NC) has launched a blog about patient recruitment and retention tips, enrollment issues, and the importance of site support at http://www.icts.us/blog.
• Enabling BioClinica (Newtown, PA) with clinical trial management software with Microsoft Office interoperability is its recent acquisition of TranSenda International (Bellevue, WA).
• Expanding its health outcomes measurement capabilities, Ingenix (Eden Prairie, MN) acquired QualityMetric Incorporated (Lincoln, RI).
Eric G. Solon, PhD
• Celerion (Lincoln, NE) completed the acquisition of the development and regulatory services consultancy and early stage development operations of MDS Pharma Services located in Lincoln, NE; Neptune, NJ; Phoenix, AZ; Richmond, VA; Quebec, Canada; Zurich, Switzerland; and Belfast, Northern Ireland.
• Expanding its facilities, Quintiles (Research Triangle Park, NC) has relocated its Global Central Laboratory in Japan from Saitama to Tokyo.
• Clearstone Central Laboratories (Toronto, Canada) is expanding its Toronto laboratory, increasing safety and esoteric testing capacities and capabilities.
• Nominations are now being accepted for the Regulatory Affairs Awards until May 24, 2010. To nominate your colleague or team, visit www.regulatoryaffairsawards.org. Email awards@topra.org or call +44 (0) 20 7510 2560 for more information. Awards will be presented at the Gala Dinner at the 2010 Annual Symposium on October 5, 2010.
Study Finds Many Randomized Clinical Trials Have Poorly Justified Exclusion Criteria
January 21st 2025Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.