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November, 2006 Issue
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Medical Device CRO or Independent Consultant: How Do You Choose?
Can A Statistician Build A Better Mouse Trap - Or a Better Clinical Trial
Risk Management, Regulation, and Relevant Steps: Thoughts on Optimizing Process
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October, 2006 Issue
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HUD/HDE: Is There a Quick Way to Market?
Medical Device Manufacturing and Regulations: Part 1 of a Series
Tight Submission Strategy: Pursuing Only Needed Data
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December, 2007 Issue
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FDA's Draft Guidance Overview
Business Mentoring - A Protégé's Perspective
Medical Device Manufacturing Regulations - Internal Audit Process
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November, 2007 Issue
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How do you Measure Up?
The Art of Sample Size Calculations
The Many Aspects of Clinical Trials - The Clinical Team
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October, 2007 Issue
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Milestones and Setting Expectations for Clinical Projects
Selecting Good Study Sites
Medical Device Manufacturing and the Regulations:
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September, 2007 Issue
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Business and Operations' Strategy Sync
Meeting Your Enrollment Goals
The Most Significantly Misunderstood Topic in Research
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August, 2007 Issue
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Medical Device Manufacturing and the Regulations
The Importance of the Informed Consent Process
The Role of the Clinical Department in Product Development Cycle
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July, 2007 Issue
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Continuous Improvement in a Regulated Environment
The Power of Randomized Experiments
Reauthorizing Medical Device User Fees through the year 2012
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June, 2007 Issue
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The Clinical Research Associate's "Degree"
Medical Device Manufacturing and the Regulations
Reimbursement and Its Role in Regulatory Strategies
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May, 2007 Issue
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Integrating Lean and Six-Sigma
Blinding in Medical Device Trials
Agreeing on Clinical Study Objectives Isn't Easy
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April, 2007 Issue
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Foreign Clinical Trials, Lessons Learned
What Makes a Good Clinical Research Associate?
Medical Device Manufacturing and Regulations: The Audit
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March, 2007 Issue
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Statistical Lessons from the Acorn Cardiovascular Experience
Adverse Event Reporting: Considerations and Regulatory Requirements
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February, 2007 Issue
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European Class IIa Medical Device Approval Routes
Medical Device Manufacturing and Regulations: Part III©
Clinical Post-Market Studies: Mere Days Away from Public Scrutiny
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January, 2007 Issue
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The Problem of Missing Data in Clinical Trials
PERVASIVE PARANOIA: What does the Acorn dispute resolution mean?
Participate in the 2007 Manufacturing Compensation & Benefits Survey
Overview of FDA's Postmarket Program for Medical Devices
Clinical Trials: Why Go Global?
Third Party Reviewers: A First Rate Process?
Medical Device Manufacturing and Regulations:
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June, 2008 Issue
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Local Industry Snapshot: Vision Ease, Virtual Radiologic, St. Jude Medical
Medical Device Manufacturing Regulations, Product Recall from the Field
The Search for the Perfect Employee
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May, 2008 Issue
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Local Snapshot: Nonin Medical, American Medical, Medtronic, and Myocor
Practical Adaptive Clinical Study Designs for Medical Devices
The Informed Consent Process - Protection of Human Subjects
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April, 2008 Issue
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Challenges in Clinical Trial Enrollment
Medical Device Manufacturing and the Regulations, Documentation Control
Industry News: Uroplasty Inc., Medtronic Inc. & Starkey Laboratories
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March, 2008 Issue
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Aspects of Clinical Trials - Technical Support at Medical Device Implant
The Clinical Trials Arms Race
Local Industry Snapshot
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February, 2008 Issue
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Emerging Employee Retention Practices in Manufacturing Companies
Medical Device Manufacturing and the regulations, training
Local Industry Snapshot
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January, 2008 Issue
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Multicenter Clinical Trials
Local Industry Snapshot
The Many Aspects of Clinical Trials - Investigator and Site Training
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