• 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
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

Halloran Consulting Group

Theranos: A Cautionary Tale

November 24, 2015 By MassDevice

By Michael Wienholt, RAC Recently, we’ve been receiving inquiries from some of our IVD clients about the latest developments with Theranos, Inc. They want to know if Theranos’ troubles indicate a shift in FDA policy toward regulation of IVDs or whether it is merely another indication of FDA enforcement action against CLIA laboratories offering LDTs. […]

Filed Under: Blog Tagged With: Halloran Consulting Group

Choosing the right quality assurance auditor

August 25, 2015 By MassDevice

By Halloran Consulting Group, Inc Read the full post on Halloran’s insights page. You are more than halfway through conducting your pivotal clinical trial when all of a sudden it hits you: something is missing. As you review the study expenses, you realize that the study budget does not have a line item for the […]

Filed Under: Blog Tagged With: Halloran Consulting Group

FDA releases draft guidance on the request for quality metrics

August 14, 2015 By MassDevice

By Halloran Consulting Group, Inc Read the full post on Halloran’s insights page. The Food and Drug Administration (FDA) released a draft guidance on the Request for Quality Metrics on July 29, 2015 and it is open for comment through September 29, 2015. The following summary provides a simplified review of the draft guidance and […]

Filed Under: Blog Tagged With: Halloran Consulting Group

Halloran announces Inc. Magazine recognition as one of America’s fastest-growing companies for second year running

August 14, 2015 By MassDevice

By Halloran Consulting Group, Inc Halloran Consulting Group, Inc. (Halloran) has been recognized for the second year in a row by Inc. magazine as one of the fastest-growing private companies in the country, placing on the annual Inc. 5000. Started in 1982, this prestigious list of the nation’s most successful private companies has become the […]

Filed Under: Blog Tagged With: Halloran Consulting Group

Inverting the clinical trial/physician relationship: The future (and data) is in the practice

July 23, 2015 By MassDevice

By Mark Vermette Traditionally, in the pharmaceutical and biotech worlds, a pharma company finds a candidate product and works with a group of doctors to test that product under careful standards and procedures. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients for that purpose. The roles […]

Filed Under: Blog Tagged With: Halloran Consulting Group

Remote auditing – It’s not all or nothing

July 22, 2015 By MassDevice

By Susan Gould, MBA, MS With the improvement in secure documentation sharing, many auditors are utilizing remote auditing practices to conduct audits. This saves travel time and costs and can be an efficient auditing method. However, this does not mean that all audits should be completed entirely remotely. For example, Good Manufacturing Practices (GMP) and […]

Filed Under: Blog Tagged With: Halloran Consulting Group

Creating a compliant, lock-tight site budget for clinical trials

May 28, 2015 By MassDevice

Halloran logo

By Kathi Shah, MS, MBA

Creating a clinical trial site budget sounds simple right? A Sponsor contracts with an investigative site to conduct a clinical trial per the protocol. The Investigative site is compensated by the Sponsor to conduct the services outlined in the protocol. The relationship between the Sponsor and Investigative site is heavily weighted on the budget developed to compensate sites for their efforts to conduct the study.

Filed Under: Blog, Clinical Trials, News Well Tagged With: Halloran Consulting Group

FDA gives public access to Global Unique Device Identification Database (GUDID)

May 19, 2015 By MassDevice Leave a Comment

Halloran logo

By Angela Brown

Filed Under: Blog, Food & Drug Administration (FDA), News Well Tagged With: Halloran Consulting Group

FDA releases update on 2014-2015 strategic priorities

May 8, 2015 By MassDevice Leave a Comment

Halloran logo

By Angela Brown

Filed Under: Blog, News Well Tagged With: Halloran Consulting Group

Key Strategies to Staying in Control of Your Study Financial Forecast

April 27, 2015 By MassDevice Leave a Comment

Halloran logo

By Dyana Boutwell

I know, clinical financial forecasting is everyone’s favorite topic. Don’t hold back your excitement in wanting to think all about your budget management responsibilities. Now is it because you are struggling to keep on top of your study budget? Is your forecast up, down, up again, and you are seeing fire come from the eyes of your Finance rep? I’ve been there. I’ve seen the fire. And I’d like to take this opportunity to give you some key pointers to throwing the bucket of water so all is peas and carrots at the monthly Finance meeting.

Filed Under: Blog, News Well Tagged With: Halloran Consulting Group

Analysis on FDA clarifying stance on accepting clinical trial data conducted OUS

April 24, 2015 By MassDevice Leave a Comment

FDA embracing the electronic age we live in: New draft guidance issued on Electronic Informed Consent (eIC)

Filed Under: News Well Tagged With: Halloran Consulting Group

  • Go to page 1
  • Go to page 2
  • 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