Tag: Clinical

Syneos Health Wins Society for Clinical Research Sites Eagle Award for Fourth Consecutive Year

MORRISVILLE, N.C., Oct. 13, 2020 (GLOBE NEWSWIRE) — Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, today announced that it was awarded the Society for Clinical Research Sites (SCRS) Eagle Award, sweeping the CRO category for the fourth consecutive year. Presented at SCRS’s Global Site Solutions Summit, the award recognizes the CRO that best exemplifies a site-focused approach to clinical trial management, demonstrating outstanding leadership, professionalism, integrity, passion and dedication to advancing the clinical research profession through strong site partnerships.

“We are honored that sites have consistently selected Syneos Health as their CRO of choice in recent years, pointing to the progress we’ve made in streamlining pain points in the clinical trial process,” said Tara Fitzgerald, President, Clinical Development Services, Syneos Health, who accepted the award on behalf of the company at the Summit. “It’s especially humbling in a year where we’ve been proud to work side-by-side with sites to navigate the challenges of COVID-19, transforming approaches to deliver impact for patients and continuing to unlock data to change lives. We thank our dedicated employees and the investigative sites we work with who continuously strive to improve the clinical development process.”

This year’s winners were selected by investigative sites – nearly 10,000 research sites in 47 countries – who voted for the CRO they believe best demonstrates a strong commitment to site partnerships. Selection criteria included availability of qualified staff to support sites, willingness to collaborate, protocol design and execution, financial consideration and partnering with sites for future work.

“Syneos Health has won the SCRS Eagle Award for three previous years in the CRO category, and this fourth win is in a very different landscape,” said Allyson Small, SCRS COO. “The pandemic disruption stretched operational systems in clinical research, making relationships critically important, with the sites recognizing Syneos Health in particular for their prioritization of the site partnership.”  

Learn more about Syneos Heath’s site and patient engagement programs, including the Company’s Catalyst Site Program that delivers proven predictability in clinical trial delivery for for Early Phase, Oncology, Psychiatry, Vaccine, Ophthalmology and Post-Operative Pain and Pain trials: syneoshealth.com/catalyst

About Syneos Health
Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit  syneoshealth.com or subscribe to our podcast.

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Tenax Therapeutics Announces Late-Breaking Clinical Trial Presentation of Phase 2 HELP Study at Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting

MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF will be presented at the upcoming Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting to be held September 30, – October 6. Scheduling details and registration information are provided below:

Title:

 

Levosimendan Improves Hemodynamics and Submaximal Exercise Capacity In PH-HFpEF: Primary Results From The HELP-PH-HFpEF Multicenter Randomized Controlled Trial

 

 

Speaker:

 

Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic

 

 

Session:

 

Late-Breaking Clinical Trials I (LBCT I)

 

 

Date/Time:

 

Saturday, October 3, 4:30 – 5:30 PM

   

Registration and additional HFSA information are available at the HFSA website: https://hfsa.org/hfsa-announces-late-breaking-clinical-trials-sessions-hfsa-virtual-asm-2020.

Tenax CEO Anthony DiTonno stated, “We are very excited to have the HELP Study results presented as a late-breaking clinical trial at the HFSA Annual Meeting. We believe the results may represent a potential advance in the treatment of PH-HFpEF patients who currently have no FDA-approved therapies to treat their condition. We look forward to having the detailed trial results presented at this major scientific forum.”

About Phase 2 HELP Trial

The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.

About Levosimendan

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject

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