Clinical research

Phlexglobal Providing Vital Support for COVID-19 Clinical Trials

Tuesday, June 2, 2020 - 7:00pm

To help meet these needs, Phlexglobal is providing specialized technology and services to fast track COVID-19 trials without compromising quality .

Key Points: 
  • To help meet these needs, Phlexglobal is providing specialized technology and services to fast track COVID-19 trials without compromising quality .
  • To date, fifteen different companies have turned to Phlexglobal for clinical or regulatory support for COVID-19 studies or submissions.
  • In the early stages of the pandemic, Phlexglobal began support for a top-20 Biotech Company engaged in a global COVID-19 clinical trial.
  • Companies engaged in drug development should contact Phlexglobal at phlexglobal.com/contact for immediate regulatory and clinical support.

Tigermed Lauded by Frost & Sullivan for Its Rapid, Large-Scale Clinical Developmental Services

Tuesday, June 2, 2020 - 3:00pm

LONDON, June 2, 2020 /PRNewswire/ --Based on its recent analysis of the Chinese contract research organizations (CROs) market, Frost & Sullivan recognizes Tigermed with the 2020 Chinese Customer Value Leadership Awardfor its full clinical developmental services.

Key Points: 
  • LONDON, June 2, 2020 /PRNewswire/ --Based on its recent analysis of the Chinese contract research organizations (CROs) market, Frost & Sullivan recognizes Tigermed with the 2020 Chinese Customer Value Leadership Awardfor its full clinical developmental services.
  • Tigermed's clinical trial services include regulatory affairs, biometrics, clinical operations and data management, and post-marketing studies.
  • Additionally, its host of value-added clinical services cover areas such as imaging, pharmacovigilance, and central laboratory services..
  • "We are honored to be recognized by Frost & Sullivan," said Xiaochun Cao, Co-founder, Executive Director and General Manager of Tigermed.

Tigermed Lauded by Frost & Sullivan for Its Rapid, Large-Scale Clinical Developmental Services

Tuesday, June 2, 2020 - 3:00pm

LONDON, June 2, 2020 /PRNewswire/ --Based on its recent analysis of the Chinese contract research organizations (CROs) market, Frost & Sullivan recognizes Tigermed with the 2020 Chinese Customer Value Leadership Awardfor its full clinical developmental services.

Key Points: 
  • LONDON, June 2, 2020 /PRNewswire/ --Based on its recent analysis of the Chinese contract research organizations (CROs) market, Frost & Sullivan recognizes Tigermed with the 2020 Chinese Customer Value Leadership Awardfor its full clinical developmental services.
  • Tigermed's clinical trial services include regulatory affairs, biometrics, clinical operations and data management, and post-marketing studies.
  • Additionally, its host of value-added clinical services cover areas such as imaging, pharmacovigilance, and central laboratory services..
  • "We are honored to be recognized by Frost & Sullivan," said Xiaochun Cao, Co-founder, Executive Director and General Manager of Tigermed.

Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy

Tuesday, June 2, 2020 - 2:30pm

The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study.

Key Points: 
  • The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study.
  • The Company announced in early February 2020 that this pivotal trial had reached the halfway point for enrollment.
  • "We believe we continue to check all the boxes required for an NDA submission," commented Myron Holubiak, Chief Executive Officer of Citius.
  • This would be between 10 to 14 hours of aggregate, but intermittent, exposure time of the catheter to Mino-Lok.

Global Prostate Cancer Clinical Trial Pipeline Highlights 2020, Segmented by Clinical Trial Stage, Drug Mechanism Class and Company - ResearchAndMarkets.com

Tuesday, June 2, 2020 - 4:30pm

The "Global Prostate Cancer Clinical Trial Pipeline Highlights - 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Prostate Cancer Clinical Trial Pipeline Highlights - 2020" report has been added to ResearchAndMarkets.com's offering.
  • This report provides the most up-to-date information on key pipeline products in the global Prostate Cancer market.
  • It covers emerging therapies for Prostate Cancer in active clinical development stages including early and late-stage clinical trials.
  • The report provides Prostate Cancer pipeline products by clinical trial stages including both early and late-stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage.

YPrime Launches eCOA Solution to Enhance the Patient Experience in Clinical Trials

Tuesday, June 2, 2020 - 2:00pm

"The rapid adoption of eCOA is driving the future digital transformation of clinical research, said Michael Hughes, Senior Vice President, Product Development/Aubrey Llanes, eCOA Product Director.

Key Points: 
  • "The rapid adoption of eCOA is driving the future digital transformation of clinical research, said Michael Hughes, Senior Vice President, Product Development/Aubrey Llanes, eCOA Product Director.
  • "The key difference between today's clinical trial and the virtual model is the shift to the patients' domain as the center of activity.
  • All eCOA deployments are supported by experienced project managers and global helpdesk coverage to ensure fit-for-purpose solution design, risk management throughout a clinical study and quick resolution of technical issues.
  • eCOA and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials.

OrphoMed Resumes Recruitment for Phase 2 Adaptive Design Study of ORP-101 for Treatment of IBS-D

Tuesday, June 2, 2020 - 1:35pm

OrphoMed paused screening of new patients on March 27, 2020, in response to the COVID-19 pandemic.

Key Points: 
  • OrphoMed paused screening of new patients on March 27, 2020, in response to the COVID-19 pandemic.
  • Study screening will resume on a clinical investigational site-by-site basis as authorities lift shelter-in-place directives.
  • During the study screening hold, we worked diligently to continue the study as planned and to treat and evaluate patients already participating in the study safely and effectively, said Dr. Steinberg.
  • We look forward to continued support from our investigators and study staff to efficiently complete the planned enrollment in this study.

Greenphire Launches New Clinical Trial Budget Build and Negotiation Solution, EnvisiX

Tuesday, June 2, 2020 - 1:00pm

EnvisiX seamlessly integrates with eClinicalGPS , Greenphire's industry-leading site payment solution, enabling unprecedented simplicity and efficiency throughout a trial from budget creation and negotiation to management, execution, and tracking of global investigator grants.

Key Points: 
  • EnvisiX seamlessly integrates with eClinicalGPS , Greenphire's industry-leading site payment solution, enabling unprecedented simplicity and efficiency throughout a trial from budget creation and negotiation to management, execution, and tracking of global investigator grants.
  • "Greenphire is dedicated to engineering workflow and data solutions that transform business processes, reducing administrative burden and improving process effectiveness at each step of the clinical trial," said Jim Murphy, Greenphire CEO.
  • "With EnvisiX, stakeholders gain visibility and control over historically manual and fragmented budget build and negotiation workflows, ensuring improved speed and accuracy along the way."
  • Greenphire's best-in-class solutions optimize clinical trial performance by streamlining payment and logistical workflows from sponsors and CROs to sites and patients.

2020 Global Post-Operative Pain Clinical Trial Pipeline Highlights: Pipeline Products to be Launched Up to 2025 - ResearchAndMarkets.com

Tuesday, June 2, 2020 - 12:39pm

This report provides the most up-to-date information on key pipeline products in the global Post-Operative Pain market.

Key Points: 
  • This report provides the most up-to-date information on key pipeline products in the global Post-Operative Pain market.
  • It covers emerging therapies for Post-Operative Pain in active clinical development stages including early and late-stage clinical trials.
  • The report provides Post-Operative Pain pipeline products by clinical trial stages including both early and late-stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage.
  • Find out which Post-Operative Pain pipeline products will be launched in the US and beyond to 2025.

Asana BioSciences Announces Positive Topline Results from Phase 2b Study of Oral JAK/SYK Inhibitor Gusacitinib (ASN002) in Patients with Chronic Hand Eczema: Rapid and Significant Improvement Demonstrated

Tuesday, June 2, 2020 - 1:00pm

The topline results show that gusacitinib achieved a dose-dependent, clinically meaningful, and statistically significant improvement relative to placebo in both the primary and key secondary endpoints of efficacy.

Key Points: 
  • The topline results show that gusacitinib achieved a dose-dependent, clinically meaningful, and statistically significant improvement relative to placebo in both the primary and key secondary endpoints of efficacy.
  • Chronic hand eczema (CHE) is a debilitating condition that affects approximately 10% of the U.S. population and millions of people worldwide.
  • We are excited by the results of this Phase 2b clinical study, said Sandeep Gupta, PhD, Founder and CEO of Asana BioSciences.
  • We look forward to advancing gusacitinib to Phase 3 development and making it available for patients suffering from moderate-to-severe CHE.