Medical research

Medable Appoints Ching Tian to Lead Strategy and Solutions Division to Further Advance Its Leadership Position in Digital Trials

Retrieved on: 
Monday, December 16, 2019
Data management, Biotechnology, Technology, Health, Security, Research, Software, Networks, Internet, Science, Clinical trials, Health, Clinical research, Medical research, Contract research organizations, Clinical pharmacology, Food and Drug Administration, Pharmaceutical industry, Covance, Clinical trial

Medable Inc ., a leading provider of a digital trials platform that connects patients, sites and clinical trial teams, today announced the appointment of Ching Tian as Senior Vice President, Strategy and Solutions, to further advance its leadership position in the clinical trials space.

Key Points: 
  • Medable Inc ., a leading provider of a digital trials platform that connects patients, sites and clinical trial teams, today announced the appointment of Ching Tian as Senior Vice President, Strategy and Solutions, to further advance its leadership position in the clinical trials space.
  • In October, the Company announced an ex-Covance veteran, Alison Holland, joined the team to lead its Virtual Trials division.
  • Digital technologies have the ability to revolutionize clinical trials by reducing clinical trial times, increasing accessibility, and diversity.
  • Im looking forward to working with the team to deliver faster, better, digital trials, said Ching Tian as SVP, Strategy and Solutions, Medable.

Catabasis Pharmaceuticals Announces Phase 3 PolarisDMD Trial Enrolled Expected Patient Population

Retrieved on: 
Monday, December 16, 2019
Biotechnology, Pharmaceutical, Health, Clinical trials, Clinical research, Design of experiments, Medical research, Health, Research, Randomized controlled trial, Placebo-controlled study, Mesoblast, Amatuximab, Edasalonexent (CAT-1004), Phase 3 PolarisDMD Trial, Catabasis

We are pleased to see that as expected, the patient population enrolled in our Phase 3 PolarisDMD trial is consistent with the patient population enrolled in the Phase 2 MoveDMD trial, which supports our design for the Phase 3 trial.

Key Points: 
  • We are pleased to see that as expected, the patient population enrolled in our Phase 3 PolarisDMD trial is consistent with the patient population enrolled in the Phase 2 MoveDMD trial, which supports our design for the Phase 3 trial.
  • Our ongoing global Phase 3 PolarisDMD trial is evaluating the efficacy and safety of edasalonexent for registration purposes.
  • The global Phase 3 PolarisDMD trial is a one-year, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of edasalonexent in patients with DMD.
  • Top-line results from the Phase 3 PolarisDMD trial are expected in the fourth quarter of 2020.

StudyKIK Announces New Mobile Study Application for Patients in Clinical Trials to Revolutionize Patient Engagement & Retention During Study Participation

Retrieved on: 
Monday, December 16, 2019
Health, Pharmaceutical industry, Clinical trials, Clinical research, Medical research, Articles, Advertising, Patient recruitment, Recruitment, Patient participation, Clinical trial portal

IRVINE, Calif., Dec. 16, 2019 /PRNewswire-PRWeb/ -- StudyKIK, a clinical trial patient recruitment and technology company that owns hundreds of digital patient communities and provides technology solutions for clinical trials, has announced its Patient Engagement & Retention Mobile Application that is fully-customizable per protocol.

Key Points: 
  • IRVINE, Calif., Dec. 16, 2019 /PRNewswire-PRWeb/ -- StudyKIK, a clinical trial patient recruitment and technology company that owns hundreds of digital patient communities and provides technology solutions for clinical trials, has announced its Patient Engagement & Retention Mobile Application that is fully-customizable per protocol.
  • StudyKIK's Patient Engagement & Retention Application provides a user-friendly technology for clinical trial participants that are randomized into clinical trials.
  • This patient centric mobile application is expected to have up to 73% increase in patient study retention and over 200% increase in patient engagement through the application.
  • StudyKIK's Chief Strategy Officer Sam Haiden stated,
    "StudyKIK's new patient retention & engagement app will revolutionize the way patients and research sites interact during a clinical trial.

Moberg Pharma Comments on the Results of the North American Phase 3 Study With MOB-015

Retrieved on: 
Thursday, December 12, 2019
Health, Clinical research, Design of experiments, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Medical research

On Monday December 9th, the topline results were presented from the first of two clinical studies in the Phase 3 program for MOB-015.

Key Points: 
  • On Monday December 9th, the topline results were presented from the first of two clinical studies in the Phase 3 program for MOB-015.
  • The fact that MOB-015 achieved mycological cure in 70 percent of the patients in this study is exceptional and exceeded our expectations.
  • It is too early to draw any firm conclusions from the first study in the Phase 3 program.
  • Topline results from the North American study are now available, followed by results in Europe expected in the second quarter of 2020.

Clinical Trials of Texas, Inc. Adds Local Psychiatrist to Site

Retrieved on: 
Wednesday, December 11, 2019
Health, Clinical research, Clinical pharmacology, Clinical trial, Design of experiments, Pharmaceutical industry, Medical research

SAN ANTONIO, Dec. 11, 2019 /PRNewswire-PRWeb/ -- Clinical Trials of Texas, Inc. (CTT) is proud to announce the addition of Thomas R. Weiss, MD to its research site.

Key Points: 
  • SAN ANTONIO, Dec. 11, 2019 /PRNewswire-PRWeb/ -- Clinical Trials of Texas, Inc. (CTT) is proud to announce the addition of Thomas R. Weiss, MD to its research site.
  • Dr. Weiss will be responsible for oversight of Central Nervous System (CNS) research studies as a Principal Investigator (PI).
  • Dr. Weiss, who has a private psychiatry practice in San Antonio, has participated in more than 400 research studies over a span of 20 years.
  • He is also frequently sought after to participate in the speakers' bureaus for pharmaceutical companies because of his expertise in CNS clinical research.

AG Mednet's Judi // Eligibility to Streamline Patient Enrollment Processes in Clinical Trials

Retrieved on: 
Wednesday, December 11, 2019
Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Clinical trial, Design of experiments

BOSTON, Dec. 11, 2019 /PRNewswire/ --Patient enrollment is one of the most expensive and delicate aspects of a new clinical trial.

Key Points: 
  • BOSTON, Dec. 11, 2019 /PRNewswire/ --Patient enrollment is one of the most expensive and delicate aspects of a new clinical trial.
  • Judi // Eligibility, the newest offering within AG Mednet's clinical trial SaaS platform, streamlines central eligibility review workflows in trials, and aggregates data to quickly achieve a final determination.
  • Trial managers and investigator sites must adhere to a strict patient acquisition process within a short, measurable time period.
  • Judi // Eligibility can be used in standard and customized configurations with workflows that can be chosen at the outset of a trial to determine eligibility.

PharmaCyte Biotech Finalizes Pancreatic Cancer Treatment for U.S. FDA Approval to Begin Clinical Trial

Retrieved on: 
Wednesday, December 11, 2019
Health, Medical research, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry

NEW YORK, NY, Dec. 11, 2019 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) has a clinical trial product, a clinical trial protocol, including a clinical trial design, a Principal Investigator, and the company is ready to present its treatment for locally advanced, inoperable pancreatic cancer (LAPC) to the U.S. FDA in an effort to secure approval to begin a Phase 2b clinical trial in LAPC.

Key Points: 
  • NEW YORK, NY, Dec. 11, 2019 (GLOBE NEWSWIRE) -- PharmaCyte Biotech (OTCQB: PMCB) has a clinical trial product, a clinical trial protocol, including a clinical trial design, a Principal Investigator, and the company is ready to present its treatment for locally advanced, inoperable pancreatic cancer (LAPC) to the U.S. FDA in an effort to secure approval to begin a Phase 2b clinical trial in LAPC.
  • Pancreatic cancer is usually only controllable through removal by surgery and only if found before it has spread to other parts of the body or other organs.
  • PharmaCyte plans to conduct a Phase 2b clinical trial with a treatment that uses genetically engineered cells to treat cancer.
  • The pancreatic cancer community should be anxiously awaiting PharmaCytes submission of its IND to the FDA and the subsequent days following as everyone waits patiently for the FDA to approve what could be a landmark clinical trial in LAPC.

Clinical Quality Experts Gather in London This February for ExL's Euro Clinical Quality Risk Management Forum

Retrieved on: 
Wednesday, December 11, 2019
Clinical research, Pharmaceutical industry, Medical research, Health, Clinical trials, Good practice, Good clinical practice

NEW YORK, Dec. 11, 2019 /PRNewswire/ --The European Clinical Quality Oversight Forum and the European Clinical Inspection Readiness Summit have merged to form the European Clinical Quality Risk Management Forum .

Key Points: 
  • NEW YORK, Dec. 11, 2019 /PRNewswire/ --The European Clinical Quality Oversight Forum and the European Clinical Inspection Readiness Summit have merged to form the European Clinical Quality Risk Management Forum .
  • The new, reinvented conference attracts senior-level clinical quality, compliance, and operations professionals from leading pharmaceutical, biotechnology, and medical device companies all over the world.
  • Panel discussions offer interactive opportunities to address proactive risk management post-ICH E6 R2, issue management and serious breach, and the latest inspection buzz.
  • Leave the event with the tools and contacts you need to advance your clinical quality risk management.

WCG Launches AIMS 4.1 Platform with Enhanced Endpoint Adjudication Capabilities to Facilitate Expert Review of Clinical Trial Data

Retrieved on: 
Tuesday, December 10, 2019
Health, Clinical research, Pharmaceutical industry, Food and Drug Administration, Medical research, Clinical trial, Design of experiments, Clinical

An Endpoint Adjudication Committee is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical safety or efficacy events of interest.

Key Points: 
  • An Endpoint Adjudication Committee is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical safety or efficacy events of interest.
  • Custom-built to streamline the adjudication process, the AIMS web-based platform allows global medical experts to seamlessly review pre-packaged clinical trial event data and provide their expert assessment, through a single interface.
  • "WCG ACI Clinical deeply understands expert committees and how to optimize their value in clinical programs.
  • WCG ACI Clinical is a specialty provider of clinical trial committees and clinical trial advisory services.

CartiHeal Announces Positive Interim Analysis Results of Agili-C™ IDE Study

Retrieved on: 
Monday, December 9, 2019
Health, Clinical research, Design of experiments, Medical statistics, Medical research, Articles, Clinical trial, Clinical study design, Randomized controlled trial, Interim analysis, IDE

The EAC reviewed the IA safety and efficacy results and recommended to stop accrual for anticipated success.

Key Points: 
  • The EAC reviewed the IA safety and efficacy results and recommended to stop accrual for anticipated success.
  • The Agili-C IDE study is a multicenter, 2:1 randomized, open-label and controlled trial.
  • According to the study design, the first Interim Analysis took place following enrollment of the first 250 Subjects.
  • Inthe United States, the Agili-C implant is not available for sale it is an investigational device limited for use in the IDE clinical study.