Outline of clinical research

Altasciences Performs Phase I Studies for FDA Approval of Vibegron

Tuesday, February 23, 2021 - 4:52pm

Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing three early phase clinical trials.

Key Points: 
  • Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing three early phase clinical trials.
  • We take tremendous pride in contributing to the FDA approval of much-needed medicines that improve the health and wellbeing of patients, said Amy Denvir, General Manager at Altasciences Kansas clinical pharmacology unit.
  • Altasciences expert clinical teams provided clinical support for two drug-drug interaction studies and a bioavailability trial, conducted in 2018 and 2019, in healthy subjects.
  • These trials were supported by Altasciences data services team, who performed the full data management and reporting for the associated clinical studies.

Cybin to Provide Business Update on February 17, 2021 Conference Call

Thursday, February 11, 2021 - 2:02pm

Cybin makes no medical, treatment or health benefit claims about Cybins proposed products.

Key Points: 
  • Cybin makes no medical, treatment or health benefit claims about Cybins proposed products.
  • Cybin has not conducted clinical trials for the use of its proposed products.
  • Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials.
  • If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Mydecine Innovations Group Engages the ProPharma Group to Proceed with FDA Filings and Approval for Novel Research and Multiple Phase Clinical Trials

Tuesday, December 15, 2020 - 12:30pm

As part of the agreement, ProPharma Group will provide regulatory advisement as the company seeks approval from the Food and Drug Administration (FDA) for its drug development platform as well as the Companys various stage clinical trials.

Key Points: 
  • As part of the agreement, ProPharma Group will provide regulatory advisement as the company seeks approval from the Food and Drug Administration (FDA) for its drug development platform as well as the Companys various stage clinical trials.
  • Mydecine currently has a jam-packed clinical trial calendar with plans to expand it to include additional various phase trials throughout the globe.
  • We look forward to working with the Mydecine team as they seek FDA approval for their clinical trials and drug development pipeline.
  • Mydecine Innovations Group is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing wellbeing.

Crucial Data Solutions Forms Partnership with Durham Tech to Support Clinical Research Education

Tuesday, May 26, 2020 - 10:00am

Crucial Data Solutions, Inc. (CDS), a provider of innovative software to advance clinical research, and Durham Technical Community College, an academic institution in North Carolina, announced today they have formed an academic partnership.

Key Points: 
  • Crucial Data Solutions, Inc. (CDS), a provider of innovative software to advance clinical research, and Durham Technical Community College, an academic institution in North Carolina, announced today they have formed an academic partnership.
  • As of the spring semester 2020, Durham Techs Clinical Trials Research Associate and Medical Product Safety/Pharmacovigilance Programs have been using CDS data collection and study management platform, TrialKit, to teach students about regulatory-compliant clinical research processes.
  • Founded in 2010, Crucial Data Solutions (CDS) provides the most innovative and affordable data collection and clinical trial management technology on the market today.
  • The Durham Tech Clinical Trials Research Associate (CTRA) program is a member of the Consortium of Academic Programs in Clinical Research (CoAPCR) and is recognized as a leader in the clinical research academic community.

Global Healthcare Brand Improves Safety Reporting in Clinical Trials Leveraging Pharmacovigilance Analytics| Quantzig

Tuesday, May 12, 2020 - 1:45pm

Safety reporting in clinical trials requires tested statistical methods that have to be specified with the regulatory authorities before the trial even begins.

Key Points: 
  • Safety reporting in clinical trials requires tested statistical methods that have to be specified with the regulatory authorities before the trial even begins.
  • Quantzigs data analytics solutions are specifically designed to help healthcare organizations enhance the safety reporting in clinical trials.
  • The pharma industry is not the only stakeholder of pharmacovigilance, but surely the primary stakeholder, thus companies must focus on safety reporting in clinical trials says an analytics expert at Quantzig.
  • Our safety reporting clinical trials help companies to analyze performance of critical trial data in real-time.

Guided Therapeutics and FDA Meet; Agree on Path Forward in Approval Process

Thursday, April 30, 2020 - 3:21pm

As a previous step, the Company filed on February 17, 2020 its FDA Pre-Submission document, which summarized LuVivas new indication for use and supporting clinical trial design.

Key Points: 
  • As a previous step, the Company filed on February 17, 2020 its FDA Pre-Submission document, which summarized LuVivas new indication for use and supporting clinical trial design.
  • Five days prior to its meeting, FDA provided the Company with written comments on its Pre-submission document detailing its approach for a new clinical trial to support U.S. approval.
  • The meeting with FDA was both positive and constructive, providing a path forward in the approval process, said Gene Cartwright, CEO.
  • The Guided Therapeutics LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.

OncoImmune Receives FDA Approval for COVID-19 Clinical Trial

Wednesday, April 8, 2020 - 7:40pm

OncoImmune, Inc. has received a study-may-proceed letter from the FDA for its Phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients (SAC-COVID).

Key Points: 
  • OncoImmune, Inc. has received a study-may-proceed letter from the FDA for its Phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients (SAC-COVID).
  • The SAC-COVID trial consists of two interim analyses, respectively, for safety and therapeutic activity, and for therapeutic efficacy.
  • This is a double blind, randomized, multi-center clinical trial.
  • SARS-CoV-2 causes clinical symptoms by killing cells in the lung and by causing inflammation that further exacerbates clinical symptoms.

Global AI-Enabled Drug Discovery and Clinical Trials Markets, 2019-2030 - ResearchAndMarkets.com

Tuesday, April 7, 2020 - 5:00pm

The "Global AI-Enabled Drug Discovery and Clinical Trials Market: Analysis and Forecast, 2019-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global AI-Enabled Drug Discovery and Clinical Trials Market: Analysis and Forecast, 2019-2030" report has been added to ResearchAndMarkets.com's offering.
  • Biopharmaceutical companies are the major end-users of the AI-enabled drug discovery and clinical trials market in terms of revenue share.
  • The Global AI-Enabled Drug Discovery and Clinical Trials Market can be segmented on the basis of component type, application, therapeutic application, end-user, and region.
  • Which region is anticipated to serve as an emerging market for drug discovery and clinical trials, respectively?

Spaulding Clinical Research Awarded Five-Year Contract With FDA

Thursday, February 27, 2020 - 1:00pm

Spaulding Clinical Research today announced that it has been awarded a five-year contract with the U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science to conduct multiple clinical trials in various therapeutic areas of interest.

Key Points: 
  • Spaulding Clinical Research today announced that it has been awarded a five-year contract with the U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science to conduct multiple clinical trials in various therapeutic areas of interest.
  • Spaulding Clinical is responsible for conducting the trials and providing the necessary support services including clinical trial recruitment, conduct, and laboratory assessments.
  • Spaulding Clinical is perfectly suited to conduct these trials as we have the right-sized project management and principal investigator team that will be able to give the FDA office the attention they need, said Cassandra Erato , CEO at Spaulding Clinical Research.
  • Spaulding Clinical has been working with the U.S. government on clinical trials over the past seven years.

Two Day Clinical Evaluation of European Medical Devices Course (London, United Kingdom - June 3-4, 2020)

Tuesday, December 17, 2019 - 1:15pm

DUBLIN, Dec. 17, 2019 /PRNewswire/ -- The "Clinical Evaluation of Medical Devices: The Clinical Evaluation Report" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 17, 2019 /PRNewswire/ -- The "Clinical Evaluation of Medical Devices: The Clinical Evaluation Report" conference has been added to ResearchAndMarkets.com's offering.
  • This two day course will cover all the aspects of clinical evaluation in line with the European Medical device regulations and applicable guidance documents.
  • The course will provide you with the tools and skills you will need to produce a high quality clinical evaluation report for all your medical devices.
  • You will learn how the process fits into the development of a medical device and also the post market aspects of clinical evidence.