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Articles Tagged "clinical"

Value Analysis Committees, EU’s MDR Highlighted in OMTEC Surgeon Keynote

by BONEZONE | Apr 2017

Increased regulatory scrutiny and payor power continue to affect healthcare globally, leading companies to create cross-department teams and seek collaboration amongst customers within the supply chain in order to remain innovative and competitive.... Read more »

CiToxLAB acquires AccelLAB Clinical Research Organization

by BONEZONE | Nov 2016

AccelLAB specializes in the pre-clinical assessment of new medical devices in orthopaedics and other specialties.... Read more »

Adaptive Designs Provide Clinical Trial Flexibility

by Hannah Corcoran | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | Nov 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Five Steps to Regulatory Strategy Development

by Mark D. Kramer, RAC | Mar 2014

Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage.... Read more »

National Joint Registry for England, Wales and Northern Ireland: Findings from 10th Annual Report

by BONEZONE | Dec 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

ORTHOWORLD Announces FDA Official to Serve as Panelist at Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC)

by BONEZONE | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Grace College Set For New Year of Orthopaedic Master's Program

by BONEZONE | Feb 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Rethinking the Role of Clinical Affairs

by Joel Batts | Feb 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Selecting an Imaging Contract Research Organization for Orthopaedic Clinical and Preclinical Research

by Brett Hoover, MS | Dec 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Medical Metrics Selected as Imaging Core Lab for Multiple FDA Metal-on-Metal Hip Studies

by BONEZONE | Dec 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Aptiv Solutions Opens New Office in North Carolina

by BONEZONE | Nov 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Imaging Modality Review for Orthopaedic Clinical Research

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA to Guide Device Makers on Marketing Application

by BONEZONE | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up

by Hamish Forster, Ph.D. | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership

by Allyn Decker | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Daily Documentation Essentials: A Tour of the Regulatory Binder

The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority. Historical precedent... Read more »

The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?

by BONEZONE | Sep 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace

by BONEZONE | Jun 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Notified Body Requirements for Clinical Literature Evaluation

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Clinical Strategy Review for CE Marking

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »