Articles

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Research Article
New Benchmarks for Trial Initiation Activities
Applied Clinical Trials
Mary Jo Lamberti, Kenneth Getz
12/1/2016
Research Article
IRB-Investigative Site Relationship Makeover
Applied Clinical Trials
Kenneth Getz
12/1/2016
Research Article
Quantifying the Magnitude and Cost of Collecting Nice-To-Have Clinical Trial Data
Chimica Oggi - Chemistry Today
Kenneth Getz
11/1/2016
Research Article
Innovative Drug Availability in China
Nature Reviews Drug Discovery
Kenneth Kaitin
10/21/2016
Research Article
Assessing Global Clinical Supply Logistics
Applied Clinical Trials
Mary Jo Lamberti, Kenneth Getz
10/1/2016
Research Article
Finally, Standardized KPIs are Front and Center
Applied Clinical Trials
Kenneth Getz
10/1/2016
Research Article
A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals
Drug Safety
Kenneth Getz
9/15/2016
Research Article
Investigating Investment in Biopharmaceutical R&D
Nature Reviews Drug Discovery
Joseph DiMasi
9/12/2016
Research Article
Competitive Development in Pharmacologic Classes: Market Entry and the Timing of Development
Clinical Pharmacology & Therapeutics
Joseph DiMasi
9/12/2016
Research Article
Assessing Practices & Inefficiencies with Site Selection, Study Start-Up, and Site Activation
Applied Clinical Trials
Mary Jo Lamberti, Kenneth Getz
8/5/2016
Research Article
Insights Into Capturing Collaborative Value
Applied Clinical Trials
Kenneth Getz
8/1/2016
Research Article
Hard Truths about Executing Outsourcing Relationships
Pharmaceutical Outsourcing
Mary Jo Lamberti, Kenneth Getz
7/21/2016
Research Article
Public- and Private-Sector Contributions to the Research and Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy
Therapeutic Innovation & Regulatory Science
Joseph DiMasi
5/20/2016
Research Article
Bridging the Academia/Industry Chasm: Proposed Solutions
The Journal of Clinical Pharmacology
Paul Beninger, Kenneth Getz
5/6/2016
Research Article
Identifying And Valuing Patient Group Engagement Methods
Value in Health
Kenneth Getz
5/1/2016
Research Article
Is Earlier Signal Detection Always Better?
Drug Safety
4/11/2016
Research Article
Acknowledging Cycle Time Impact from Protocol Amendments
Applied Clinical Trials
Kenneth Getz
4/1/2016
Research Article
The Impact of Protocol Amendments on Clinical Trial Performance and Cost
Therapeutic Innovation & Regulatory Science
Kenneth Getz
2/22/2016
Research Article
Assessing The Discovery Outsourced Services Market
Life Science Leader
Kenneth Getz
2/1/2016
Research Article
Clinical Trial Knowledge Missed, Gained, and Shared
Applied Clinical Trials
Kenneth Getz
2/1/2016
Research Article
Optimizing Collaboration Effectiveness in Alliance Partnerships
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
1/28/2016
Research Article
Mobile Nurse Services in Clinical Trials: Usage and Industry Perceptions
Therapeutic Innovation & Regulatory Science
Kenneth Getz
1/27/2016
Research Article
Regulatory Definitions and Good Pharmacovigilance Practices in Social Media: Challenges and Recommendations
Therapeutic Innovation & Regulatory Science
12/30/2015
Research Article
An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2015
Research Article
Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2015
Research Article
An Examination of eClinical Technology Usage and CDISC Standards Adoption
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Kenneth Getz
11/1/2015
Research Article
A New Look at the Arsenal of Tech Solutions
Applied Clinical Trials
Kenneth Getz
10/1/2015
Research Article
A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds
Clinical Pharmacology & Therapeutics
Joseph DiMasi, Kenneth Getz
8/3/2015
Research Article
ROI for Patient-Centric Drug Development
Applied Clinical Trials
Kenneth Getz
8/1/2015
Research Article
The Unintended Inefficiencies of Outsourcing Practice
Pharmaceutical Outsourcing
Mary Jo Lamberti, Kenneth Getz
7/31/2015
Research Article
Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices
Drug Safety
Kenneth Getz
6/25/2015
Research Article
Compliance with Results Reporting at ClinicalTrials.gov
The New England Journal of Medicine
Kenneth Getz
6/11/2015
Research Article
Characterizing the Real Cost of Site Regulatory Compliance
Applied Clinical Trials
Kenneth Getz
6/1/2015
Correspondence
The Cost of Drug Development
New England Journal of Medicine
Joseph DiMasi
5/14/2015
Research Article
The Transformative Promise of Patient-Centric R&D
Pharmaceutical Business Review
Kenneth Getz
5/7/2015
Research Article
Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins
Therapeutic Innovation & Regulatory Science
Kenneth Getz
4/15/2015
Research Article
Establishing Return-on-Investment Expectations for Patient-Centric Initiatives
Therapeutic Innovation & Regulatory Science
Kenneth Getz
4/15/2015
Research Article
Giving Pharma Credit for Medical Innovation
Applied Clinical Trials
Kenneth Getz
4/1/2015
Research Article
Quantifying the Magnitude and Cost of Collecting Extraneous Protocol Data
American Journal of Therapeutics
Kenneth Kaitin, Kenneth Getz
3/1/2015
Research Article
The Evolution Of Biotechnology And Its Impact On Health Care
Health Affairs
Kenneth Kaitin
2/1/2015
Commentary
Meeting Unmet Medical Needs: The Disparity Dilemma
Pharmaceutical Executive
Kenneth Kaitin
2/1/2015
Research Article
The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation
Health Affairs
Joseph DiMasi
2/1/2015
Research Article
Closing in on Opportunities to Simplify Protocol Design
Applied Clinical Trials
Kenneth Getz
2/1/2015
Book Chapter
Chapter 1 - Why Is the Pharmaceutical and Biotechnology Industry Struggling?
Re-Engineering Clinical Trials
Kenneth Kaitin, Kenneth Getz
1/1/2015
Book Chapter
Chapter 10 - The Impact of Bad Protocols
Re-Engineering Clinical Trials
Kenneth Kaitin, Kenneth Getz
1/1/2015
Research Article
Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice
Therapeutic Innovation & Regulatory Science
Kenneth Getz
12/30/2014
Research Article
Evaluating the Completeness and Accuracy of MedWatch Data
American Journal of Therapeutics
Kenneth Kaitin, Kenneth Getz
11/1/2014
Research Article
Taking the Pulse of Strategic Outsourcing Relationships
Clinical Therapeutics
Mary Jo Lamberti, Kenneth Kaitin, Kenneth Getz
10/1/2014
Research Article
Is 'Open Integration' Beyond Our Reach?
Applied Clinical Trials
Kenneth Getz
10/1/2014
Research Article
Adaptive Trial Design: Prepping for Adoption
Pharmaceutical Executive
Kenneth Getz
6/19/2014