OmniComm Systems, Inc. (OTCBB:OMCM), a leading global provider of eClinical solutions, announced today that it was selected as the EDC System of choice by Menlo Park, CA based Intersect ENT for its RESOLVE Clinical Study, a Novel In-Office Treatment option for Chronic Sinusitis Patients.
"We selected OmniComm's system after considering many other options. Our decision was based on TrialMaster's natural and intuitive user interface, and its ability to seamlessly produce validated SDTM data exports created directly from the TrialMaster database. With SDTM datasets available shortly after commencing patient enrollment, we have significantly sped up the process of managing our study and identifying potential data issues. We anticipate that OmniComm's state of the art technology will allow rapid database closure, analyses and results that comply with FDA's expectations," said James Stambaugh, Vice President of Clinical Affairs and Reimbursement.
Intersect's new product, a Steroid Eluting Implant for Post Sinus Surgery Patients, is placed in vivo during a routine physician office visit, and is designed as a treatment alternative for patients with recurrent sinus obstruction. The RESOLVE Study plans to enroll 100 patients, at up to 20 U.S. sites.
"We are extremely pleased to be chosen by Intersect ENT to support their new product development," said Stephen Johnson, President and COO of OmniComm. "Intersect has developed a strong reputation for developing local drug delivery solutions to advance clinically proven therapies that improve the quality of life for many patients with ear, nose and throat conditions." Johnson further stated, "We are delighted to be partnering with them to offer solutions that will help them be more efficient in the collection and management of their clinical product development."
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Ponsegromab Significantly Improves Body Weight in Patients with Cancer Cachexia
September 17th 2024Results of a Phase II study of ponsegromab showed significant improvements in body weight, muscle function, and overall symptoms for patients with cancer cachexia, offering hope for a new targeted treatment.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.