Clinical Intelligence

Changes needed for EDC to show true efficiency

Monday, October 2, 2017

Three quarters of clinical trial managers report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases and then delays trials.
Eighty-three percent of life sciences organizations release a clinical database after the first patient, first visit. It takes an average of 68 days to build and release a clinical study database, which contributes to an increase of nearly a month downstream in the completion of a trial.

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Sound Pharmaceuticals initiates STOP Ototoxicity study in cystic fibrosis

Wednesday, September 27, 2017

Sound Pharmaceuticals (SPI) has initiated enrollment on its first study involving Cystic Fibrosis (CF) patients receiving antibiotics that cause inner ear disease or ototoxicity. The STOP Ototoxicity study is led by Patrick Flume, MD, Professor of Medicine and Pediatrics at MUSC in Charleston. Dr. Flume is an international expert in CF and pulmonary disease and has co-chaired the development of the CF Foundation’s care guidelines on the treatment of pulmonary exacerbations. “We recently explored the incidence of tinnitus and vertigo in the CF population, and will present these initial findings at the next North American CF Conference,” said Dr. Flume.

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W. L. Gore & Associates completes enrollment in GORE CARDIOFORM study

Wednesday, September 27, 2017

W. L. Gore & Associates has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The GORE® CARDIOFORM ASD Occluder is designed with a unique, anatomically adaptable waist to accommodate the natural anatomy of the heart and mitigate the potential for cardiac injury. This new device will complement the existing GORE® CARDIOFORM Septal Occluder to allow the treatment of a broader range of ASDs with a soft, conformable device design.

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Recipharm and Clinical Trial Consultants partner to streamline clinical trials

Monday, September 25, 2017

Recipharm, a contract development and manufacturing organization (CDMO), recently announced its new partnership with Swedish CRO Clinical Trial Consultants (CTC) for the development of a comprehensive list of services for first-in-human clinical trials. The partnership’s project, titled Recipharm Pathway to Clinic, is geared toward streamlining clinical trials and facilitating research from the early phase of formulation development to trial implementation.

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FDA approves Symbiomix Therapeutics’ Solosec for bacterial vaginosis

Monday, September 18, 2017

Symbiomix Therapeutics announced the FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.

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FDA grants Fast Track to Pluristem’s PLX-PAD for critical limb ischemia

Monday, September 18, 2017

Pluristem Therapeutics, a developer of placenta-based cell therapy products, announced that the FDA has granted Fast Track Designation to the company’s ongoing phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.

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Quest for patient centricity drives Greenphire and mProve payment technology partnership

Monday, September 18, 2017

With an estimated three billion smart phones now in use worldwide, clinical researchers and support companies are working to catch up with how patients want to participate in clinical trials. This powerful mobile trend is very much at the heart of a recent announcement by Greenphire and mProve Health. The two companies are joining forces to allow clinical trial patients real-time mobile access via their cell phones for a range of support functions. This includes the ability to be paid by trial sponsors electronically and make travel arrangements.

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GSK announces phase III results of mepolizumab for eosinophilic COPD

Wednesday, September 13, 2017

GlaxoSmithKline announced the publication of full results from the phase III studies for mepolizumab in chronic obstructive pulmonary disease (COPD). Data from the investigational clinical development program showed that treating eosinophilic COPD patients with the biologic medicine, mepolizumab, in addition to maximal guideline-recommended therapy, reduced exacerbations in these difficult-to-treat patients. Based on the full data, discussions with external experts and the recognized unmet medical need in this patient population, regulatory filings are planned for 2017. Mepolizumab is not approved for use anywhere in the world for COPD.

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