• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • DeviceTalks Weekly
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

IMARC

How To Make Your Clinical Monitoring Efforts Matter

February 9, 2021 By Sponsored Content

How should sponsors and sites define successful clinical monitoring today, and what can they do to ensure they achieve their goals? By John Lehmann, Director of Business Development Whether you’re performing it on-site or remotely, clinical monitoring comes with many challenges. In the past decade (and even the past year), monitoring has evolved. How should […]

Filed Under: Sponsored Content Tagged With: IMARC

Making your GCP questions easier

November 14, 2019 By Danielle Kirsh

Toni Hegyi, Manager, Quality Assurance at IMARC Research, Inc. No matter where you land on the clinical research spectrum, chances are you have encountered some challenges with interpreting and/or implementing Good Clinical Practice (GCP) guidelines. With so many trial designs and research settings, it can be difficult to know how to appropriately apply GCP and […]

Filed Under: Blog Tagged With: IMARC

Understanding the MDR & IVDR: What Medical Device Companies Need to Know

October 1, 2019 By Sponsored Content

By Brandy Chittester, MS, CCRA, President These regulations are intended to place a greater emphasis on safety, with greater requirements for clinical evidence and increased oversight by regulatory agencies. The regulations will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed […]

Filed Under: Sponsored Content Tagged With: IMARC

Understanding budgets, extra costs and feasibility in clinical research

September 19, 2019 By Danielle Kirsh

Heather S. Friar, clinical research associate, IMARC Research Understanding the cost of something is important when making a financial decision both professionally and personally.  It is imperative that one understands the cost of an item which includes the extra fees that may not be visible on the price tag.   The same is true in conducting […]

Filed Under: Blog Tagged With: IMARC

Exploring FDA approval pathways for medical devices

September 12, 2019 By Danielle Kirsh

Lisa Wickert, Clinical Research Associate at IMARC Research, Inc. If you missed Part One of our medical device series reviewing medical device classification, please check it out here! Now that we have a grasp of the FDA medical device classification fundamentals, we can begin to explore the various pathways that a new medical device may […]

Filed Under: Blog Tagged With: IMARC

Why data integrity is important for the success of clinical trials

September 4, 2019 By Danielle Kirsh

Heather S. Friar, Clinical Research Associate, IMARC Research, Inc. Data integrity is a fundamental requirement of medical research and laboratory experimentation.  All studies should be conducted according to the protocol guidelines and documented accurately and completely even if the data disproves or challenges the posted hypothesis.  As researchers, it is our responsibility to make sure […]

Filed Under: Blog Tagged With: IMARC

How Eva Mozes Kor taught patient protection in clinical trials

July 17, 2019 By Danielle Kirsh

Sandra Maddock, CEO of IMARC Research My motivations for going to professional conferences usually revolve around staying abreast of new information relevant to my field, networking with others, and earning CEUs. I’ve never gone to a professional conference expecting to be emotionally moved in a giant way, but that’s exactly what happened at an ACRP […]

Filed Under: Blog Tagged With: IMARC

Clinical Study Cleanup: How to Get Your Study Back on Track

July 1, 2019 By Sponsored Content

By Kelly Jasko, Lead Clinical Research Associate Every year, the U.S. Food and Drug Administration (FDA) releases metrics detailing the outcomes of the Bioresearch Monitoring (BIMO) inspections done at facilities conducting clinical research within the previous year. Of the 104 Sponsor/Monitor/Contract Research Organization (CRO) inspections done in fiscal year 2017, 36 percent were found to […]

Filed Under: Sponsored Content Tagged With: IMARC

FDA regulations and guidances under review

May 31, 2019 By Danielle Kirsh

Emily A. Matejka, clinical research associate, IMARC Research On April 11, a memo was released from the Office of Management and Budget (OMB) stating that United States agencies, which include the Food and Drug Administration, rules and guidances must go to the OMB’s Office of Information and Regulatory Affairs for review beginning on May 11. […]

Filed Under: Blog Tagged With: IMARC

Taking quality GCP audit snapshots

April 26, 2019 By Danielle Kirsh

John Lehmann, Director of Business Development, IMARC Research Auditing brings an independent, quality assurance perspective to the clinical research landscape. Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Auditors leverage extensive training and experience to help ensure subject safety, data integrity, and protocol and regulatory compliance. Have you considered taking a […]

Filed Under: Blog Tagged With: IMARC

The Nuremberg Code and its impact on clinical research

April 9, 2019 By Danielle Kirsh

by Natalie Jarmusik, Clinical Research Associate, IMARC Research The Nuremberg Code is one of the most influential documents in the history of clinical research. Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects. We’ll take a closer look at its […]

Filed Under: Blog Tagged With: IMARC

  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Interim pages omitted …
  • Go to page 13
  • Go to Next Page »

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS