Publication Library & Research Findings

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Research Article
Preparing for Precision Medicine
Contract Pharma
Mary Jo Lamberti, Kenneth Getz
1/30/2018
Research Article
Assessing Study Start-Up Practices, Performance and Perceptions Among Sponsors and Contract Research Organizations.
Therapeutic Innovation & Regulatory Science
Mary Jo Lamberti, Beth Harper, Kenneth Getz
1/11/2018
Research Article
Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial
Clinical Infectious Diseases
Joseph DiMasi, Kenneth Getz
1/6/2018
Research Article
Differences in Clinical Research Perceptions and Experiences by Age Subgroup
Therapeutic Innovation & Regulatory Science
Kenneth Getz
1/1/2018
Editorial
Reaching a New Innovation Threshold: How Can We Make It Happen?
Pharma Focus Asia
1/1/2018
Impact Report
eClinical Data Volume and Diversity Pose Increasing Challenges and Delays
January/February 2018
Research Article
Examining and Enabling the Role of Health Care Providers as Patient Engagement Facilitators in Clinical Trials
Clinical Therapeutics
Kenneth Getz
11/1/2017
Impact Report
Real World Evidence Use in Clinical & Post-Approval Research Set to Expand
November/December 2017
Research Article
#PatientVoiceMatters: How Social Media Is Bringing Patients and Biopharmaceutical Companies Together to Improve Drug Development
Clinical Therapeutics
10/31/2017
Research Article
Mapping the Landscape of Patient-Centric Activities Within Clinical Research
Journal of Clinical Therapeutics
Mary Jo Lamberti
10/9/2017
Whitepaper
Manufacturing Strategy for Diverse Biologic Pipelines of the Future
October 2017
Whitepaper
Assessing the Economics of Single-Source vs. Multi-Vendor Manufacturing
October 2017
Commentary
The Use of Social Media in Orphan Drug Development
Clinical Therapeutics
9/20/2017
Research Article
Baseline Assessment of a Global Clinical Investigator Landscape Poised for Structural Change
Therapeutic Innovation & Regulatory Science
Kenneth Getz
9/1/2017
Impact Report
Cardiovascular Drug Approval Rate in the US Fell as Development Time Rose
September/October 2017
Research Article
Insights and Best Practices for Planning and Implementing Patient Advisory Boards
Therapeutic Innovation & Regulatory Science
Kenneth Getz
7/25/2017
Research Article
Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project
Therapeutic Innovation & Regulatory Science
Joseph DiMasi, Kenneth Getz
7/17/2017
Research Article
Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities
Clinical Therapeutics
Kenneth Kaitin, Joseph DiMasi
7/1/2017
Impact Report
ADF Opioid Development, Uptake Tied to Efficacy, Regulatory/Payer Policies
July/August 2017
Research Article
New Benchmarks Characterizing Growth in Protocol Design Complexity
Therapeutic Innovation & Regulatory Science
Kenneth Getz
6/23/2017
Research Article
Perspectives on Past, Present and Future of Clinical Trials
Applied Clinical Trials
Mary Jo Lamberti, Kenneth Getz
6/1/2017
Research Article
Four Axioms That Will Always Explain Successful Clinical Performance
Applied Clinical Trials
Kenneth Getz
6/1/2017
Research Article
Taking Stock of Today’s Global Site Landscape
Applied Clinical Trials
Kenneth Getz
6/1/2017
Research Article
Landscape for Medical Countermeasure Development
Nature Reviews: Drug Discovery
Zachary (Zak) Smith
5/5/2017
Book Review
Drug Industry in Peril
Health Affairs
5/1/2017
Impact Report
Biotech Products Accounted For 25% of All New FDA Approvals in 2000-16
May/June 2017
Research Article
Trends in Clinical Trial Design Complexity
Nature Reviews Drug Discovery
Kenneth Getz
4/18/2017
Research Article
Trial Watch: Trends in Clinical Trial Design Complexity
Nature Reviews Drug Discovery
Kenneth Getz
4/18/2017
Research Article
Analysis of Review Times for Recent 505(b)(2) Applications
Therapeutic Innovation & Regulatory Science
Joseph DiMasi, Kenneth Getz
4/16/2017
Research Article
The Elusive Goal of Optimizing Development Operations
Applied Clinical Trials
Kenneth Getz
4/1/2017
Impact Report
Approval Time for 505(b)(2) Drugs is Nearly Five Months Longer Than for NMEs
March/April 2017
Research Article
Diagnosing Protocol Amendment Experience to Drive Clinical Trial Performance
Pharmaceutical Outsourcing
Kenneth Getz
2/1/2017
Research Article
More Efficient Compliance with European Medicines Agency and Food and Drug Administration Regulations for Pediatric Oncology Drug Development: Problems and Solutions
Clinical Therapeutics
2/1/2017
Editorial
Research and Development of Medical Countermeasures in Asia for Pandemic and Bioterror Threats
Pharma Focus Asia
Zachary (Zak) Smith
1/1/2017
Editorial
Use of Real World Evidence Increasing Throughout Asia
Pharma Focus Asia
Zachary (Zak) Smith
1/1/2017
Editorial
Regulation vs Innovation: Are We Getting It Right?
Asian Hospital & Healthcare Management
1/1/2017
Impact Report
Poor Physician and Nurse Engagement Driving Low Patient Recruitment
January/February 2017
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
Impact Report
Pediatric Regulatory Science, Clinical Trial Networks Hold Promise For Studies
November/December 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
Impact Report
Diabetes Drug Development is Riskier Compared to All Drug Development
September/October 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