Design of experiments

ClinTex (CTi) Launches CTi-OEM Blockchain Clinical Trial App

Retrieved on: 
Tuesday, August 3, 2021
Articles, Health sciences, Clinical research, Health, Pharmaceutical industry, Clinical trial, Design of experiments, Drug discovery, Blockchain

ClinTex launches 'Operational Excellence' - a blockchain clinical trial application to tackle clinical trial inefficiencies and high costs.

Key Points: 
  • ClinTex launches 'Operational Excellence' - a blockchain clinical trial application to tackle clinical trial inefficiencies and high costs.
  • With large pharma companies like Merck and Novartis already testing blockchain as a technology of the future to support their clinical trial strategy for patient information and to manage clinical trial medication, this paves the way for ClinTex CTi to partner with the industry to deliver more innovative and impactful uses of blockchain to increase clinical trial efficiency.
  • The company has prioritized the development of the CTi-OEM blockchain clinical trial app to target some of the major causes of inefficiency in clinical trials, enabling its first app to derive maximum tangible benefits for the pharma and clinical trials industry.
  • Eventually, it will consist of 7 different blockchain clinical trial applications that derive intelligent analytics from all types of clinical trial data, and it is these analytics that can be used to drive efficiency in clinical trials.

Strategikon Enhances Clinical Trial Planning and Outsourcing. Speeds Time-to-Market.

Retrieved on: 
Tuesday, August 3, 2021
Health sciences, Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Clinical trials, Design of experiments

Biopharmaceutical sponsors have several options for budget or scenario development with Clinical Maestro .

Key Points: 
  • Biopharmaceutical sponsors have several options for budget or scenario development with Clinical Maestro .
  • Clinical Maestro's database already supports over 800 standardized tasks, however, sponsors also need to create customized tasks for specific trials.
  • Clinical Maestro equips all participants in clinical trials, Sponsor Companies, Vendors and Service Providers, to budget, source and manage - faster, more accurately, and with less effort.
  • Get the power to model and plan studies and efficiently manage your clinical contracts systematically for faster time to market.

Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

Retrieved on: 
Tuesday, August 3, 2021
Health sciences, Health, Clinical research, Design of experiments, Clinical trial, Food and Drug Administration, Pharmaceutical industry, Macular degeneration

I would like to thank the trial participants and investigators, our partners, and our employees for their contributions to NORSE TWO.

Key Points: 
  • I would like to thank the trial participants and investigators, our partners, and our employees for their contributions to NORSE TWO.
  • The NORSE TWO pivotal Phase 3 clinical trial enrolled a total of 228 subjects with wet AMD across 39 clinical trial sites in the United States.
  • The safety results demonstrated in NORSE TWO are consistent with previously reported safety results from Outlook Therapeutics NORSE ONE and NORSE THREE clinical trials.
  • NORSE TWO provided pivotal data that demonstrated positive and highly statistically significant and clinically relevant efficacy and safety data for treatment of patients with wet AMD.

CenterWatch Announces -- The PI Trainer: An Interactive Companion to The PI's Guide to Conducting Clinical Research

Retrieved on: 
Tuesday, August 3, 2021
Health sciences, Health, Clinical research, Pharmaceutical industry, Clinical trial, Design of experiments, Food and Drug Administration

As a PI, one is responsible for all aspects of a study and must gain proficiency in each of them to do the job well.

Key Points: 
  • As a PI, one is responsible for all aspects of a study and must gain proficiency in each of them to do the job well.
  • The PI Trainer a new visual, interactive online course empowers one to do just that and earn 3.0 continuing education units at the same time.
  • This companion to The PI's Guide to Conducting Clinical Research enables readers to conduct better, safer and more efficient clinical trials by providing self-paced training.
  • Also available: Take advantage of our site licenses of The PI Trainer, so one will have the most-informed PI's!

Cytokinetics Announces Start of COURAGE-ALS, a Phase 3 Clinical Trial of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis

Retrieved on: 
Monday, August 2, 2021
Health sciences, Clinical research, Design of experiments, Health, Medical research, Cytokinetics, Clinical trial, Placebo-controlled study

SOUTH SAN FRANCISCO, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), a Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS), is open to enrollment. Reldesemtiv, a next-generation fast skeletal muscle troponin activator (FSTA) arising from Cytokinetics’ skeletal muscle contractility program, slows the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers, which sensitizes the sarcomere to calcium, leading to an increase in skeletal muscle contractility. COURAGE-ALS follows FORTITUDE-ALS, a Phase 2 clinical trial of reldesemtiv that demonstrated encouraging results supportive of progression to a pivotal Phase 3 clinical trial.

Key Points: 
  • COURAGE-ALS follows FORTITUDE-ALS, a Phase 2 clinical trial of reldesemtiv that demonstrated encouraging results supportive of progression to a pivotal Phase 3 clinical trial.
  • COURAGE-ALS, a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv is expected to enroll approximately 555 patients with ALS.
  • Cytokinetics expects to start a Phase 3 clinical trial of CK-274 in patients with obstructive HCM by year end.
  • The company is conducting COURAGE-ALS, a Phase 3 clinical trial of reldesemtiv in patients with ALS.

CymaBay Announces $100 Million Non-Dilutive Financing with Abingworth

Retrieved on: 
Monday, August 2, 2021
Health sciences, Health, Pharmaceutical industry, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments

NEWARK, Calif., Aug. 02, 2021 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced a $100 million non-dilutive financing transaction with Abingworth to fund the Phase 3 development program for seladelpar in primary biliary cholangitis (PBC), including the Phase 3 RESPONSE clinical trial.

Key Points: 
  • Under the terms of the transaction, CymaBay will receive up to $100 million of seladelpar development costs, of which $75 million will be received in three installments over approximately six months.
  • CymaBay has an option to receive a further $25 million within approximately two months of the completion of enrollment of CymaBays Phase 3 RESPONSE clinical trial.
  • In exchange, CymaBay will make fixed payments spread over a six-year period based on regulatory approval in the U.S. or the E.U.
  • CymaBay has the ability to accelerate payment at a reduced amount upon regulatory approval and in the event of a change of control of CymaBay.

Sensyne grows medical research dataset to 60 million patients

Retrieved on: 
Monday, August 2, 2021
Data management, Biotechnology, Technology, Health, Pharmaceutical, Other Technology, Medical devices, Software, Internet, Mobile, Wireless, Clinical trials, Health sciences, Health, Clinical research, Pharmaceutical industry, Medical research, Clinical pharmacology, Clinical trial, Design of experiments, Sensyne Health, Phesi Inc., SENSYNE HEALTH, PHESI INC.

Between December 2020 and July 2021 Phesi grew its clinical research and clinical trial dataset from 13 million to 42 million patients through a concerted effort in acquiring and structuring data registries of de-identified data.

Key Points: 
  • Between December 2020 and July 2021 Phesi grew its clinical research and clinical trial dataset from 13 million to 42 million patients through a concerted effort in acquiring and structuring data registries of de-identified data.
  • At the same time, Sensyne, through its unique ethical Strategic Research Agreement (SRA) model that partners with healthcare systems, grew its real world patient dataset from 6 million to over 18 million patients.
  • Sixty million patients is an important milestone in our journey to create the worlds best data resource for medical research.
  • The 42 million Phesi clinical research and clinical trial dataset does not form part of this 100 million target.

Global Atrial Fibrillation Clinical Trials Review Report - H1, 2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, July 30, 2021
Health, Clinical trials, Health sciences, Health, Clinical research, Clinical trial, Design of experiments, Food and Drug Administration, Pharmaceutical industry, Atrial fibrillation

The "Atrial Fibrillation - Global Clinical Trials Review, H1, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Atrial Fibrillation - Global Clinical Trials Review, H1, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This report provides an overview of Atrial Fibrillation Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Atrial Fibrillation.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.

Immuno-oncology Clinical Trials Market Research Report 2021: Analysis by Phase (Phase I, Phase II, Phase III, Phase IV), Design (Interventional Trials, Observational Trials), & Indication - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021
Pharmaceutical, Health, Oncology, Clinical trials, Health sciences, Health, Clinical research, Clinical trial, Design of experiments, Drug discovery, Pharmaceutical industry

The "Immuno-oncology Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Design (Interventional Trials, Observational Trials), by Indication, by Region and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Immuno-oncology Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Design (Interventional Trials, Observational Trials), by Indication, by Region and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.
  • The global immuno-oncology clinical trials market size is expected to reach USD 15.1 billion by 2028.
  • The rapidly growing field of Immuno-oncology has emerged as a novel therapeutic area within the oncology ecosystem, transforming the treatment of cancer.
  • At the end of 2019, over 40.0% of current immuno-oncology clinical experiments involved at least one location in the region
    Chapter 3 Immuno-oncology clinical trials Market: Variables, Trends, & Scope
    Chapter 4 Immuno-oncology Clinical Trials Market: Phase Segment Analysis
    4.1 Immuno-oncology Clinical Trials Market: Phase Market Share Analysis, 2020 & 2028

Gonorrhea Clinical Trials Review, H2 2021 Research Report - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021
Health, Clinical trials, Health sciences, Health, Pharmaceutical industry, Clinical research, Life sciences, Clinical trials, Drug discovery, Design of experiments

The "Gonorrhea - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Gonorrhea - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Gonorrhea - Global Clinical Trials Review, H2, 2021" provides an overview of the Gonorrhea Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Gonorrhea.
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
    Facilitates clinical trial assessment of the indication on a global, regional and country level
    Clinical Trials by G7 Countries: Proportion of Gonorrhea to Infectious Disease Clinical Trials
    Clinical Trials by E7 Countries: Proportion of Gonorrhea to Infectious Disease Clinical Trials