| Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial ...
CHICAGO, Nov. 15 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (NASDAQ: ADLS) , today announced positive results from Trial CL-05, the second of two pivotal phase III clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day oral antibiotic for the treatment of mild-to-moderate community acquired pneumonia (CAP), the sixth leading cause of death in the United States. The primary efficacy endpoint of statistical non-inferiority in the clinical cure rate at the test-of-cure visit was achieved. The study results showed that cethromycin cured 94.0% of patients with CAP, compared to Biaxin(R) (clarithromycin), a current standard of care treatment for CAP, which cured 93.8% of studied patients in the per protocol population. In the modified intent to treat population, cethromycin cured 83.1% of patients and Biaxin cured 81.1%.
SigmaSoft International Partners with Netrics to Create MedDRA and ...
PRINCETON, N.J., Sept. 27 /PRNewswire/ -- Netrics, a leading innovator and provider of intelligent database record matching software, today announced a partnership with SigmaSoft International, a global supplier of data management software solutions for clinical trials. The two companies collaborated on a new auto encoder/browser for defining MedDRA and WHODrug terminology. SigmaSoft recognized the need for automating the coding of adverse event and concomitant medication terminology to facilitate meeting the compliance standards for pharmaceutical and medical device clinical trial data. "We wanted to find a partner who could help our clients standardize terminology easily and cost-effectively," explained Steve Colville, CEO of SigmaSoft. "Netrics was the perfect fit, providing the best fuzzy search technology to deliver excellent results and also providing a solution that is affordable for small and mid-sized medical research companies.
PPD Names Senior Vice President of Global Biostatistics and Data ...
WILMINGTON, N.C., Aug. 7 /PRNewswire-FirstCall/ -- PPD, Inc. (NASDAQ: PPDI) today announced Susan Atkinson, Ph.D., has been promoted to senior vice president of global biostatistics and data management. In her new role, Dr. Atkinson provides strategic direction for the company's global biostatistics and data management business, including electronic data capture operations, CSS Informatics and PPD Medical Device. "Throughout her tenure with PPD, Dr. Atkinson has demonstrated the ability to build effective teams and deliver the highest level of quality service to our customers," said William Sharbaugh, chief operating officer of PPD. "Her expertise in statistical analysis, clinical trial design, regulatory submission strategies and EDC will serve her well in leading her group in providing clients integrated services for the conduct of multinational clinical trials." Dr.
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