Outline of clinical research

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

Retrieved on: 
Tuesday, December 17, 2019
Medical device, Pharmaceutical industry, Clinical research, Clinical trial, Outline of clinical research

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.

Central Nervous Systems (CNS) Therapeutic Drug Monitoring - World Medical Devices Pipeline Assessment Report, 2019 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 19, 2019
Pharmaceutical, Health, Medical devices, Health, Articles, Clinical research, Pharmaceutical industry, Design of experiments, Clinical pharmacology, Pharmacy, Clinical trial, Therapeutic drug monitoring, Outline of clinical research

The "Central Nervous Systems Therapeutic Drug Monitoring - Medical Devices Pipeline Assessment, 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Central Nervous Systems Therapeutic Drug Monitoring - Medical Devices Pipeline Assessment, 2019" report has been added to ResearchAndMarkets.com's offering.
  • This report provides an overview of Central Nervous Systems Therapeutic Drug Monitoring currently in pipeline stage.
  • The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development.
  • It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Central Nervous Systems Therapeutic Drug Monitoring pipeline products.

Medable Expands Executive Leadership Team With Clinical Trials Veteran Alison Holland

Retrieved on: 
Thursday, October 31, 2019
Oncology, Data management, Health, Technology, Clinical trials, Pharmaceutical, Biotechnology, Health, Clinical research, Medical research, Articles, Pharmaceutical industry, Clinical trials, Contract research organizations, Corning Inc., Covance, Clinical trial portal, Outline of clinical research

Medable Inc ., a leading provider of a digital trial platform connecting patients, sites, and clinical trial teams, today announced the expansion of its leadership team with the addition of Alison Holland as Head of Virtual Trials.

Key Points: 
  • Medable Inc ., a leading provider of a digital trial platform connecting patients, sites, and clinical trial teams, today announced the expansion of its leadership team with the addition of Alison Holland as Head of Virtual Trials.
  • Ms. Holland brings over 30 years of clinical trial experience, most recently as Global VP & General Manager for General Medicine at Covance, a leading global clinical research organization (CRO).
  • Im excited to join the Medable team, as we continue to advance and push the boundaries of digital trials.
  • Medables end-to-end digital trial platform allows patients, healthcare providers, clinical research organizations, and pharmaceutical sponsors to work together as a connected and empowered team in clinical trials and research.

Medical Device Studies: Clinical Evidence (London, United Kingdom - May 13-14, 2019) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 1, 2019
Health, Medical devices, Medical device, CE marking, Pharmaceutical industry, Health, Articles, Clinical research, Clinical trials, Outline of clinical research, Biomedical engineering

The "Medical Device Studies: Clinical Evidence" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Medical Device Studies: Clinical Evidence" conference has been added to ResearchAndMarkets.com's offering.
  • Clinical evidence is key to bringing a device to market and is a very important aspect of post-market evidence gathering to meet the legislation.
  • The collection of clinical data to demonstrate safety and performance is pivotal to CE marking a medical device and the collection of post-market data is key to the continued safety and performance considerations once the device is on the market.
  • This course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices.

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting (London, United Kingdom - October 1-2, 2019) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 6, 2019
Health, Clinical trials, Medical devices, Health, Clinical research, Pharmaceutical industry, Articles, Medical device, Adverse event, Pharmacovigilance, Outline of clinical research

The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting" conference has been added to ResearchAndMarkets.com's offering.
  • An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting.
  • This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and post-market clinical follow-up (PMCF) studies with particular emphasis on the adverse event reporting requirements during these studies.
  • The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives.

2-Day Seminar: Medical Device Studies - Regulatory Requirements and Adverse Event Reporting (London, United Kingdom - April 2-3, 2019) - ResearchAndMarkets.com

Retrieved on: 
Friday, February 22, 2019
Health, Medical devices, Health, Clinical research, Pharmaceutical industry, Articles, Food and Drug Administration, Clinical trial, Design of experiments, Product testing, Adverse event, Medical device, Pharmacovigilance, Outline of clinical research

The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting" conference has been added to ResearchAndMarkets.com's offering.
  • An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting
    This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and post-market clinical follow-up (PMCF) studies with particular emphasis on the adverse event reporting requirements during these studies.
  • The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives.
  • It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period.

Dr. Francesca Joseph, Former FDA Medical Officer, Office of Orphan Products Development, Joins NDA Partners

Retrieved on: 
Wednesday, February 13, 2019
Health, Articles, Drug discovery, Food and Drug Administration, Pharmaceutical industry, Clinical research, Medical statistics, Clinical trial, Orphan drug, Consultant, Draft:Voisin Consulting Life Science, Outline of clinical research

Dr. Joseph is a board certified pediatrician with expertise in pediatric therapies, clinical study design, humanitarian use devices, orphan designation, and pediatric trials.

Key Points: 
  • Dr. Joseph is a board certified pediatrician with expertise in pediatric therapies, clinical study design, humanitarian use devices, orphan designation, and pediatric trials.
  • In addition to her career at FDA, she has worked in private practice and in emergency medicine at Children's National Medical Center (Washington DC).
  • NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide.
  • Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

CENTOGENE Expands Clinical Studies Team in U.S.

Retrieved on: 
Monday, January 28, 2019
Health, Biotechnology, Clinical trials, Genetics, Pharmaceutical, Health, Articles, Medicine, Drug discovery, Biomarkers, Biotechnology, Chemical pathology, Clinical trial, Orphan drug, Outline of clinical research, Saliva testing

CENTOGENE today announced the expansion of its clinical studies team, with the appointment of a number of clinical researchers to support its U.S. laboratory operations located in Cambridge, Massachusetts.

Key Points: 
  • CENTOGENE today announced the expansion of its clinical studies team, with the appointment of a number of clinical researchers to support its U.S. laboratory operations located in Cambridge, Massachusetts.
  • The goal of this expanded team is to support the development of solutions that accelerate the development of orphan drugs.
  • CENTOGENEs growing team of clinical researchers will drive global genetic testing programs and metabolic biomarker studies for orphan drug discovery.
  • CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients.

Galmed Pharmaceuticals to Report Third Quarter 2018 Financial Results and Provide Business Update on Monday, November 5

Retrieved on: 
Monday, October 29, 2018
Health, Clinical research, Pharmaceutical industry, Clinical trial, Design of experiments, Drug discovery, Product testing, Tcelna, Outline of clinical research

Galmed is a clinical-stage biopharmaceutical company focused on the development of Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations.

Key Points: 
  • Galmed is a clinical-stage biopharmaceutical company focused on the development of Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations.
  • Galmed recently announced top-line results of the ARREST Study, a multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study designed to evaluate the efficacy and safety of Aramchol in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic.
  • Galmed is currently preparing for an end of Phase IIb meeting with the FDA to discuss the results of the ARREST Study and a Phase III study protocol, with a view to initiating a Phase III clinical study of Aramchol in 2019.