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Case Studies
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Premier Research is always working to exceed the expectations of our sponsors, from meeting and beating aggressive timelines to overcoming enrollment challenges to managing studies in complex therapeutic areas and indications.
The following case studies demonstrate recent success stories where we applied our therapeutic and operational expertise to deliver services of the highest quality for our sponsors.
Analgesia
Case Study: Meeting Aggressive Timelines for a New Drug Application
Case Study: A Pivotal Multiple Dose Efficacy Study in Bunionectomy
Case Study: Access to Large Subject Population for Acute Pain Studies
Case Study: Ahead of Schedule with Excellent Results for a Large Pain Study
Case Study: Accelerated Enrollment for 3-study Fibromyalgia Program
Case Study: Supporting FDA Requests
Case Study: Overcoming Challenging Timelines for an Analgesia Study
Case Study: Reducing the Timeline for an Osteoarthritis Study
Cardiovascular
Case Study: Providing Support from Concept to Market
Case Study: Managing a Global Registry for Acute Coronary Syndrome
Case Study: Value of Rapid Enrollment using CEE Sites for Type II Diabetes
Case Study: Meeting Aggressive Timelines
Case Study: Local Knowledge Makes the Difference
Medical Device
Case Study: Meeting Aggressive Timelines
Case Study: Achieving Project Plans and CE Marking Goals
Case Study: Providing Comprehensive Services for a Combination Product
Case Study: Local Knowledge Makes the Difference
Case Study: Managing Core Labs
Case Study: Field Corrective Action
Neuroscience
Case Study: Thorough Training and Experienced Team
Case Study: Managing an Alzheimer's Disease Study with Complex Assessments
Case Study: Overcoming Challenges in Parkinson's Disease Study
Case Study: Integrating Data from 25 Clinical Trials for the Treatment of Anxiety
Case Study: Comprehensive Clinical Plan Development
Oncology
Case Study: Managing High Performance Global Project Teams
Case Study: Managing a 3-Study Dose Finding Oncology Program
Case Study: Preferred Medical Monitoring Vendor for Oncology Studies
Case Study: Providing Comprehensive Services for Prostate Cancer
Case Study: Developing an Adaptive Design for an Oncology Study
Case Study: Overcoming Recruitment Challenges in a Breast Cancer Study
Case Study: Managing Across Continents for a Breast Cancer Study
Pediatrics
Case Study: Managing a Pediatric Trial in an Orphan Indication
Case Study: Overcoming Enrollment Challenges for a Pediatric Study
Case Study: Meeting Enrollment despite Pediatric Patient Population
Case Study: Managing Naïve Investigators for a Large Pediatric ADHD Study
Biometrics
Case Study: Beating the Clock to Database Lock
Case Study: Providing Oracle Clinical Expertise
Case Study: Employing Electronic Data Capture
Case Study: Flexible EDC Solutions
Case Study: Providing High Quality Data Analysis
Case Study: Providing Integrated Summary of Safety for an NDA
Case Study: Creation of a Global Database
Case Study: Real-Time Access to Study Data
Case Study: Managing Clinical Supplies in a Global Trial
Case Study: Rapid Clinical Study Report Writing
Case Study: Assisting with Medical Writing Challenges
Functional Sourcing
Case Study: Dedicated Resource Outsourcing
Case Study: Outsourcing of Data Management Function using Sponsor’s Data Management System
Case Study: Providing Data Management Services Utilizing an ASP Hosted System
Case Study: Assisting with Data Services for a Pharmaceutical Acquisition
Case Study: Insourcing of Clinical Trial Support
02-Jun-10
White Paper from Premier Research Reviews how to Optimize Country Selection in Oncology Clinical Trials
28-Apr-10
White Paper from Premier Research Reviews Risk Evaluation and Mitigation Strategies (REMS) and the Impact on Opioid Analgesics
26-Apr-10
Premier Research Pediatric Experts Presented Poster at 2010 ACRP Conference
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29-Aug-10
13th World Congress on Pain
21-Sep-10
Transcather Cardiovascular Therapeutics (TCT) 2010
06-Oct-10
PERI's PSURs: Understanding the Requirements for Pre and Post-Approval Periodic Safety Reports
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