Clinical pharmacology

Clincierge Names Joy Arnold, J.D., Chief Compliance Officer

Retrieved on: 
Tuesday, July 27, 2021
Articles, Health sciences, Health, Clinical pharmacology, Digital rights, Human rights, Identity management, Privacy law, Privacy Office of the U.S. Department of Homeland Security, Chief privacy officer, Regulatory compliance, Privacy

PHILADELPHIA, July 27, 2021 /PRNewswire/ -- Clincierge , the leader in patient support services and logistics management for clinical trials, has announced the appointment ofJoy Arnold, J.D., to the role of chief compliance officer.

Key Points: 
  • PHILADELPHIA, July 27, 2021 /PRNewswire/ -- Clincierge , the leader in patient support services and logistics management for clinical trials, has announced the appointment ofJoy Arnold, J.D., to the role of chief compliance officer.
  • She will also serve as lead privacy officer, providing expert guidance on best practices related to data privacy and the protection of personally identifiable information.
  • Arnold joins Clincierge from T. Global Partners, Inc., where she was responsible for global compliance, contracting, and sourcing.
  • "The role of chief compliance officer represents a meaningful opportunity to apply my skills and expertise to an inspiring mission," Arnold said.

Agile Therapeutics Reports Second Quarter 2021 Financial Results

Retrieved on: 
Monday, July 26, 2021
Clinical pharmacology, Medical prescription, Patient safety, Symbols

PRINCETON, N.J., July 26, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three months ended June 30, 2021 and provided a corporate update.

Key Points: 
  • Management to Host Conference Call Today, Monday, July 26, 2021 at 4:30 p.m. EDT
    PRINCETON, N.J., July 26, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc.(Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three months ended June 30, 2021 and provided a corporate update.
  • The theme of Agiles 2021 second quarter is growth.
  • Recent Corporate Developments and Second Quarter 2021 Results:
    During the second quarter 2021, total prescriptions were 5,027, representing an increase of 171% from the end of the first quarter.
  • As of June 30, 2021, 2,033 prescriptions dispensed at pharmacies were refills, which represented an increase of 355% during the second quarter.

JanOne Selects CPC Clinical Research as Trial Manager for Phase 2b Study of JAN101 for Peripheral Artery Disease Patients

Retrieved on: 
Thursday, July 22, 2021
Health sciences, Health, Clinical research, Clinical pharmacology, Medical research, Clinical trial, Design of experiments, Food and Drug Administration, Pharmaceutical industry

CPC is an ARO recognized for its expertise in comprehensive clinical trial design and management for both national and international clinical research.

Key Points: 
  • CPC is an ARO recognized for its expertise in comprehensive clinical trial design and management for both national and international clinical research.
  • CPC has over 30 years of experience in managing Phase 1 to 4 clinical trials and has provided services for over 150 clinical studies.
  • "CPC has an outstanding reputation for clinical trial management and we are thrilled to have their team on board for our upcoming Phase 2b trial," said Tony Isaac, President and Chief Executive Officer of JanOne.
  • JAN101 demonstrated positive results in a Phase 2a clinical trial and the Company is currently in preparations for Phase2btrials.

Lumos Pharma Announces Clinical Updates

Retrieved on: 
Tuesday, July 20, 2021
Health sciences, Health, Life sciences, Clinical pharmacology, Clinical research, Clinical trial, Design of experiments, Pharmaceutical industry

AUSTIN, Texas, July 20, 2021 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announces an update on clinical activities.

Key Points: 
  • TheFDA has placed our planned long-term extension study on partial clinical hold until additional efficacy data from the OraGrowtH210 Trial are available to be reviewed.
  • We do not anticipate these protocol changes, on a stand-alone basis, to extend the time to the initiation of our Phase 3 clinical trial.
  • Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases.
  • This press release contains forward-looking statements of Lumos Pharma, Inc. (the Company) that involve substantial risks and uncertainties.

Medable Named Leader in Decentralized Clinical Trial Products Assessment by Everest Group

Retrieved on: 
Tuesday, July 20, 2021
Data management, Biotechnology, Technology, FDA, Health, Pharmaceutical, Medical devices, Research, Software, Science, Clinical trials, Health sciences, Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Food and Drug Administration, Clinical trial, Design of experiments, Cloud computing, Decentralized Trials & Research Alliance

Medable Inc. , the leading cloud platform for patient-centered drug development, today announced that it was named a Leader in the Decentralized Clinical Trial Products PEAK Matrix assessment by Everest Group.

Key Points: 
  • Medable Inc. , the leading cloud platform for patient-centered drug development, today announced that it was named a Leader in the Decentralized Clinical Trial Products PEAK Matrix assessment by Everest Group.
  • The new report, issued last Friday, evaluates decentralized trial products from 15 companies based on vision, capability and market impact.
  • Medable has emerged as a leader in the industry shift to decentralized clinical trials, making trials accessible for everyone everywhere and enabling effective therapies to reach patients faster.
  • Medable has deployed its software-as-a-service (SaaS) platform in more than 60 countries via more than 150 decentralized and hybrid clinical trials.

Guideway Care Signs National Agreement with Vizient, Inc. for Care Guidance Services

Retrieved on: 
Tuesday, July 20, 2021
Health care, Health, Medical terminology, Health care quality, Adherence, Clinical pharmacology, Pharmacy, Vizient, Inc., Nursing

BIRMINGHAM, Ala., July 20, 2021 /PRNewswire-PRWeb/ -- Guideway Care (Guideway), a leader in technology-enabled care guidance services that extend beyond mere navigation, announced the launch of a multi-year agreement with Vizient, Inc. (Vizient).

Key Points: 
  • BIRMINGHAM, Ala., July 20, 2021 /PRNewswire-PRWeb/ -- Guideway Care (Guideway), a leader in technology-enabled care guidance services that extend beyond mere navigation, announced the launch of a multi-year agreement with Vizient, Inc. (Vizient).
  • "With rising performance pressures, higher barriers to care, and nursing and staff shortages, addressing the practical barriers faced by patients across the care journey has become more critical.
  • Patients are often non-compliant with prescribed care paths because of practical, social, and emotional factors that can be resolved by non-clinical Care Guides.
  • Once on a care pathway, our team and technology fill gaps in care to drive compliance, better patient communication, and patient satisfaction.

New Technology to Help Increase Patient Diversity in Clinical Trials

Retrieved on: 
Monday, July 19, 2021
Health sciences, Clinical research, Health, Pharmaceutical industry, Medical research, Food and Drug Administration, Clinical pharmacology, Clinical trial, Design of experiments

Both for patients themselves and for public confidence in the drug development process, we need to improve diversity in clinical trials."

Key Points: 
  • Both for patients themselves and for public confidence in the drug development process, we need to improve diversity in clinical trials."
  • "We need diverse populations enrolled in clinical trials for proper evidence generation to help ensure that a therapy is effective for everyone it is intended to help.
  • To find new and improved ways to address the healthcare challenges facing today's socio-economic and geographically diverse patients, Rajasimha developed a technology platform to launch an effort to increase diversity in clinical trials .
  • "Clinical Trials Have Far Too Little Racial and Ethnic Diversity," Scientific American, September I, 2018, scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/
    2.Chino, Dr. Fumiko; "Minority Participation in Clinical Trials: A Call to Action"; 21 Aug 2019; Astro; astro.org/Blog/August-2019/Minority-Participation-in-Clinical-Trials-A-Call-t
    3.Klane, Lindsey.

Global Germ Cell Tumors Clinical Trials Review - H1, 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, July 19, 2021
Health, General Health, Health sciences, Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Food and Drug Administration, Clinical trial, Design of experiments

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

Key Points: 
  • 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

Global Thrombocytopenia Clinical Trials Review - H1, 2021 - ResearchAndMarkets.com

Retrieved on: 
Friday, July 16, 2021
Pharmaceutical, Health, Clinical trials, Cardiology, Health sciences, Health, Clinical research, Medical research, Pharmaceutical industry, Clinical pharmacology, Food and Drug Administration, Clinical trial, Design of experiments

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

Key Points: 
  • 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

RxS, LLC Expands U.S. Footprint in Fort Lauderdale, FL

Retrieved on: 
Thursday, July 15, 2021
Health sciences, Pharmacy, Health care, Health, Pharmaceuticals policy, Clinical pharmacology, Drugs, Prescription drug, Pharmaceutical industry, PDMA

"This is an exciting time for RxS," commented Mark Jara, RxS Principal and Managing Director.

Key Points: 
  • "This is an exciting time for RxS," commented Mark Jara, RxS Principal and Managing Director.
  • "Expanding our U.S. footprint in Fort Lauderdale was a strategic decision to help our company support the growing demand for our services, including virtual brand awareness platforms.
  • RxS LLC is the leading provider of multi-channel sample management, ensuring regulatory compliance while lessening the administrative burden of the Prescription Drug Marketing Act (PDMA).
  • RxS focuses on technology-driven, proprietary services and innovative software solutions that empower success for pharmaceutical and biotech companies around the globe.