MAIN MENU
BACK
BACK
Home
About
News & Events
Careers
Countries
Contact Us
Volunteer
PAREXEL Academy
Partners
Client Login
Explore PAREXEL
Journey
GO
Solutions
GO
Experience
GO
Outsourcing Models
GO
Planning
Phase I
Phase IIa
Phase II-III
Phase IIIb-IV
Post Launch
Clinical Research
Early Phase Services
Dedicated Therapeutic Expertise
Early Phase and Late Phase integrated study management
Patient Populations
Strategic Locations
Berlin
Virtual Tour
London
Baltimore
Facility
Virtual Tour
Los Angeles
Virtual Tour
Phase 1, First in Human
Ethnobridging for Accelerated Global Drug Development
Phase IIa, Proof of Concept
Early Product Development
Ethnobridging
Clinical PK/PD and Pharmacometrics Services
Case Study: Safety/Pharmacovigilance #1
Case Study: Safety/Pharmacovigilance #2
Bioanalytical and Biomarkers
Bioequivalence Studies
Volunteer to Participate
Phase II-III Services
Phase III
Case Study: Chronic Renal Failure
Case Study: Expanded Access Program
Case Study: Accelerating development in global COPD trials
Feasibility and Enrollment
Patient Recruitment
Case Study: Pediatric Migraine Patient Recruitment
Country and Site Selection
Alliance Site Strategy
Protocol Optimization
Phase IIIb-IV
ForeSite™ Clinical Trial Methodology
Study Design
Study Start-Up
Study Execution
Global Data Operations
Clinical Data Management
Biostatistics Services
Clinical MetaData Repository (MDR)
Medical Writing Solutions
Quantitative Clinical Development Services
Clinical Trial Supplies & Logistics
Global Reach
Clinical Trial Supplies
Ancillary Supplies
Laboratory Logistics and Biological Sample Lifecycle Management Services
Randomization and Trial Supply Management
Cold Chain Logistics
Clinical Trial Supply Chain - Active Tracking
Customer Care Services
Genomic Medicine Services
Clinical Adjudication Services
Informatics
Regulatory and Clinical Technology
Regulatory Information Management
LIQUENT InSight®
Regulatory Cloud
Regulatory Outsourcing Services
Data-Driven Monitoring
Clinical Trial Management System (CTMS)
IMPACT® CTMS Software
Electronic Data Capture
DataLabs® EDC
MyTrials® Analytics
Patient Technology
Randomization and Trial Supply Management
Clinical Trial Supplies & Logistics
Clinical Trial Supply Chain - Active Tracking
ClinPhone RTSM Mobile App
Medical Imaging
Therapeutic Expertise
Oncology Imaging Expertise
Criteria Experience
1996 NCI-WG CLL
IWCLL 2008
Key Topics: IWCLL 2008
Definitions
Usable Criteria to Evaluate
Target Sites of Disease
Non-Target Sites of Disease
Organomegaly
New Lesions
B symptoms
Blood Counts
Bone Marrow
Transformation
Role of Imaging in CLL Clinical Trials
Clinical Data Assessments
1999 IWG-NHL
2007 IWG-NHL
Key Topics: 2007 IWG-NHL Assessment Criteria
Definitions
Usable Criteria to Evaluate
Target Sites of Disease
Non-Target Sites of Disease
Organomegaly
New Lesions
Bone Marrow
Other Laboratory Values and Symptoms
Incorporation of FDG-PET
Defining Normal, Abnormal and Measurable
Problem with CRu
RECIST
Neurology Imaging Expertise
Musculoskeletal (MSK) Imaging Expertise
Women's Health Imaging Expertise
Dermatology Imaging Expertise
Gastroenterology Imaging Expertise
Ophthalmology Imaging Expertise
Volumetric Imaging Expertise
Cardiovascular Imaging Expertise
Imaging Services
Scientific Advisors
Consultation
Advanced Medical Imaging
Cloud-Based Solutions for Sites
Patient Sensors
Electronic Clinical Outcome Assessments (eCOA)
ePRO (electronic Patient Reported Outcomes)
Clinical Outcome Assessments Consulting
Clinical Trial Supplies & Logistics
Perceptive® Cloud
Asset Transfer Services
PAREXEL's Education Services
IMPACT® CTMS Training
LIQUENT InSight® Training
Courses & Registration
LIQUENT InSight® for Submission Management
LIQUENT InSight®Submission Planning and Tracking
LIQUENT SmartDesk™
Automating the Publishing Process with LIQUENT SmartDesk™ for PDF
LIQUENT InSight for Viewing
Reviewing Submissions with LIQUENT InSight® for Viewing
Training Resources
DataLabs® EDC Training
Perceptive MyTrials® Training
Data-Driven Monitoring Training
Certification Programs
Training Services
Customer Care Services
Regulatory
Regulatory Strategy & Development Planning
Regulatory GMP Compliance
Q&A about GCP
Strategic Compliance: Data Integrity
Regulatory Partnerships
Clinical Trial Regulatory Services
IDMP Solutions
IDMP Readiness Assessment
IDMP Task Force Updates
November 2015 Task Force Meeting
Access
Real World Evidence
Late Phase Clinical Operations
Late Phase Interventional Trials
Observational Research
Epidemiology
Expanded Access Programs
Clinical Outcome Assessment (COA)
Case Study: Health Economics
Outcomes Research
Real World Data Services
Drug Safety Services
Risk Management / REMS
Market Access Consulting
Commercial Decision Pathways
Evidence Generation
Evidence Review and Meta-Analysis
Evidence Review Options
Evidence Review Resources
Health Economic Modeling
Global and AMCP Value Dossiers
Manuscripts and Posters
Data Analytics
Strategic Communications
Access Realization
Pricing, Reimbursement and Market Access Expertise
List of Services: Pricing, Reimbursement and Market Access
Medical Communications
Communication Strategy
Publications Planning and Scientific Content
Expert Identification and Engagement
Global Study Engagement
Branding and Creative Strategy
Digital Media and Video Solutions
Live and Virtual Events
Payer Communication
Editorial and Production
Outsourced Field-Based Medical Teams
Therapeutic Expertise
Oncology
Cardiovascular & Metabolic Diseases
Central Nervous System (CNS) Disorders
Infectious Disease
Respiratory Capabilities
Rheumatology & Immunology Capabilities
Rare Diseases
Industry Expertise
Pharmaceuticals
Biosimilar Consulting
Medical Devices
Biologics
Biosimilars
Biosimilar Video
Regulatory Expertise
Market Access Expertise
Global Presence
North America
South America
Europe
Asia
Middle East & Africa
Emerging Markets
Strategic Partnerships
ExecuPharm Functional Service Solutions
PAREXEL® BioPharm Unit
About
News & Events
Careers
Countries
Contact Us
Volunteer
PAREXEL Academy
Partners
Client Login
Journey
Planning
Phase I
Phase IIa
Phase II-III
Phase IIIb-IV
Post Launch
Solutions
Clinical Research
Early Phase Services
Phase II-III Services
Phase IIIb-IV
ForeSite™ Clinical Trial Methodology
Global Data Operations
Medical Writing Solutions
Quantitative Clinical Development Services
Clinical Trial Supplies & Logistics
Customer Care Services
Genomic Medicine Services
Clinical Adjudication Services
Informatics
Regulatory and Clinical Technology
Patient Technology
Clinical Trial Supplies & Logistics
Perceptive® Cloud
Asset Transfer Services
PAREXEL's Education Services
Customer Care Services
Regulatory
Regulatory Strategy & Development Planning
Regulatory GMP Compliance
Regulatory Partnerships
Clinical Trial Regulatory Services
IDMP Solutions
Access
Real World Evidence
Drug Safety Services
Market Access Consulting
Medical Communications
Outsourced Field-Based Medical Teams
Experience
Therapeutic Expertise
Oncology
Cardiovascular & Metabolic Diseases
Central Nervous System (CNS) Disorders
Infectious Disease
Respiratory Capabilities
Rheumatology & Immunology Capabilities
Rare Diseases
Industry Expertise
Pharmaceuticals
Medical Devices
Biologics
Biosimilars
Regulatory Expertise
Market Access Expertise
Global Presence
North America
South America
Europe
Asia
Middle East & Africa
Emerging Markets
Outsourcing Models
Strategic Partnerships
ExecuPharm Functional Service Solutions
PAREXEL® BioPharm Unit
Company
Management Team
Jamie Macdonald
Peyton Howell
Greg Rush
Michael Crowley
Xavier Flinois
Michele Fournier
Sy Pretorius, M.D.
Gadi Saarony
News & Events
Press Releases
Events
Webinars
12th Annual Partnerships in Clinical Trials Congress
Archived PAREXEL in the News
Find an Office
Careers
Careers at PAREXEL®
CEO Message
Find Your Path - Opportunities
University Graduates – Opportunities for students
Volunteer
About Us
Locations Worldwide
About Clinical Trials
Why Participate?
FAQs
Glossary
Sustainability
Consumption Trend Analysis
Code of Conduct
eClinical Innovation
Purchasing
Purchase Order Terms and Conditions
Bedingungen für den Kaufauftrag
Vigente desde el
PO Terms - Japanese
PO Terms - Chinese 'S'
PO Terms - Chinese 'T'
Ordem de Compra Termos e Condições
Contact Us
Thank You
Partners
Service Partners
Training Partners
Technology Partners
Referral Partners
Accredited Partner Program
PAREXEL Reports U.K. Gender Pay Data
Tax Strategy
Perceptive®
User Group Meeting
IMPACT CTMS User Group Meeting Details and Agendas
IMPACT CTMS User Group Meeting Justification Letter
Meeting Registration and Hotel Details
Benefits for attending the IMPACT CTMS User Group Meeting
Registration Rates
Hotel Rates
Horizons
Agenda
Venue/Location
FAQs
RWE Symposia
About
Locations
FAQs
Agenda
Graduate | PAREXEL
Culture at PAREXEL
Former Trainees at PAREXEL
Career Trainee Meghan
Career Trainee Sam
Great Place to Work
PAREXEL Overview
Clinical Trainee Program Belgium
Clinical Trainee Program Japan
Graduate Scheme India
Clinical Research Awards
Graduate Scheme UK
parexel-insights
Utilizing Secondary Healthcare Data Assets
High Performance Workplace Practices That Attract and Retain Millennials
When It Comes to CTMS One Size Does Not Fit All
RIM & IDMP Synergies
PAREXEL's Connected Journey™ of Data-Driven Services
Josh Schultz, Corp. VP Talks About PAREXEL Access
This Disease Will Not Win the Fight
Clarifying the Criteria that Better Capture Antitumor Activity of Immune Therapeutics
'Now is the time to include Japan' says PAREXEL
Designing Trials Payers Can Trust
Clinical Trial Feasibility & Patient Enrollment: Differentiation Through Innovation
Why RTSM & IRT stand for Speed, Simplicity & Service
Interview with PAREXEL’s Aida Sabo, About Challenges & Successes in Diversity & Inclusion
New Approaches to Data Management in Clinical Trials
Protocol Optimization
Imaging Endpoint Selection For Biosimilar Development
30 Years Later: Lessons from Living in a Pandemic
3 Principles for a Sound Clinical and Regulatory Document Strategy for Small Biopharmaceuticals
Leveraging the Cloud to Accelerate Time to Treatment
Developing Drugs in the New Era of Personalized Medicines
CONSIDERATIONS IN BIOSIMILARS DEVELOPMENT– A US FDA PERSPECTIVE
Grateful for Advancements in Medicine
Orphan Drug Pricing in Europe
Involved & Engaged: The Last Mile of Business Performance
World Cancer Day: Breakthroughs and Challenges for Precision Medicine
PAREXEL’s Training Approach and the Importance of Training a Global Workforce
The Emerging Role of Wearable Devices For Real-World Data Collection
The Human Touch: Aligning Reward Systems with Company Strategy and Meaningful Work
Adaptive Trials: Complex But Advantageous
Generating Evidence to Drive Patient Access
PAREXEL's Connected Journey™ of Data-Driven Services
The Complete Journey: Improving Clinical Trials Using Modern Technology
If You Never Stop Learning, You Can Never Stop Earning
Best Practices to Improve the IRT Site User Experience
Using Analytics to Optimize The Clinical Development Process
The Collaborative Advantage of Biopharma Companies and Global Service Providers
Clinical Development of Next Generation Biologics
A People Strategy Attracts the Best Talent
Accelerated Pathways & Commercial Consequences Forum & Findings
Life is Short and Love is Eternal
Focused on the Finish Line
Albert Liou Discusses the Drug Development Landscape in Korea
Navigating Regulatory Complexities Of Biosimilar Development
Accelerated Pathways: Global Opportunities & Challenges for Innovators
How do eClincal solutions Increase Clinical Trial Efficiency?
Successfully Integrating Electronic Health Record and Electronic Data Collection Data
Immuno-Oncology: Past, Present and Future
Running with a Purpose
How Performance Reviews Support High-Performance Talent
How to Maximize Potential and Sidestep Pitfalls of MAPs
How Protocol Optimization Improves Clinical Trial Outcomes
Wearables Shaping the Future of Clinical Trials
The Clinical, Regulatory and Commercial Implications of Rapid Approval
World Cancer Day: Reflecting on Progress and Hope for Patients
Optimizing the clinical development process with Social, Mobile, Analytics, and Cloud (SMAC)
Progress in Pursuit of a Cure - World AIDS Day 2017
Overcoming Data Capture and Management Challenges
Three Keys To Mitigating Risk In Adaptive Trials
Diversity and Inclusion: This Is How the Best Global Companies Learn, Plan, and Measure Success
Attitude is Everything
Your clinical trial supply may be at risk – Brexit and the impact on IMP distribution
Why Strategy is Not Enough: Building the Bridge From Strategy to Results Requires Organizational Excellence
Data Management Roles, Process and Technologies in Risk Based Study Execution
When the Doctor Becomes the Patient
Recorded Webinar: Getting to Approval Faster Through Technology Innovation
Innovation in the Pharmaceutical Industry: A Change Toward Personalized Medicine
Dream or Reality- Improving Patient Safety & Reducing Costs?
Key Considerations In Biologics Clinical Development
Dr. Sy Pretorius, Chief Scientific Officer Talks About Adaptive Design Trials
Effective Late Stage Pathways For Biosimilar Products
Precision Medicine’s Next Hurdle: Quality Management of Human Samples
You’re Hot Then You’re Cold -Temperature Management & RTSM Integration
Clinical Trial Support Query - Who Ya Gonna Call?
How to Simplify Site Tasks and Help Ensure Dispensing Accuracy
Genomic Medicine, Data Modeling and Clinical Trials
A Biosimilar Milestone with Implications
Recognizing Uncle David
Dragons - the Guardians of Disease
Increasing Study Predictability
Navigating Regulatory Submissions
Demonstrating Value and Managing Risk Throughout Development
Shogo Nakamori Discusses Joint Program for Clinical Research
Shogo Nakamori Discusses Trends in Drug Development in Japan
Anything is Possible
Rooting for Team Jessie
Beyond Diversity: What Happens When You Define a Culture of Inclusion
Get Into Pole Position with Modern IRT Services
Drew Garty Discusses Data Driven Monitoring
Working Towards a Glimpse of a Cure
Medical Writing for Submission to Asia-Pacific Regulatory Authorities
Quantitative Modeling For Clinical Trials
PAREXEL Celebrates International Women's Day 2018
Want Your Business to Thrive? Focus on Developing Your People
On Demand Webinar - The Power of Foresight: Improving Drug Development Performance through Optimized Protocol Design
Albert Siu, PhD, Explains How PAREXEL Academy Benefits Clients
WHAT CAN WE LEARN FROM IMMUNO-ONCOLOGY CLINICAL TRIALS?
The Next Generation of Talent Management: Opportunities For Diversity
Something Good Always Comes From Something Bad
How to Know You’re Keeping Your (Clinical Trial Supplies) Cool
Contracting - A Key Component Of A Strong Vendor Relationship
Improving Site Experience with Risk-Based Monitoring
Aligning on Patient Outcomes – How Market Dynamics Can Facilitate RWD (Real World Data) Solutions in Research
Shogo Nakamori Discusses Japan & Multi-national Trials
Three Skills Developers Will Need to Thrive in the New Era of Genomic Medicine
What You Need To Know About Biosimilars Development
"Yes, I Can!"
Biosimilar mAbs – a unique and distinct market (for the time being…?)
Accelerated Pathways and Stock Prices
Surveillance or Surgery?
Mergers & Acquisitions: Where’s the Real Finish Line?
Training Compliance is an Increasingly Complex Journey
The Evolution of Drug Development & Market Access via Connected Data-driven Solutions
The Impact of the Digital Human Resources Organization on People - Part 1
The Life of a Human Biological Sample: A Look Inside and How to Maintain Its Integrity
Active Tracking Is Out To Reduce Sites’ Workload
Ubavka DeNoble Talks About PAREXEL's BioPharm Unit
The Journey Continues – I Got This
So, My Fitbit is Clinical Trial Grade Right?
Latin America’s Role in Clinical Studies
Trends in Translational Development
Effective use of Value to Achieve Optimal Market Access
Three Ways to Mitigate the Risk of Late-stage Failure in CNS Drug Development
HOW TO EFFECTIVELY DEVELOP CLINICAL DOCUMENTS IN THE EU/US AND CHINA NDA DOSSIER
The Art and Science of Productive FDA Meetings
Driving the Digital Transformation of the Industry
Regulatory Strategy In Emerging Markets
Exploring Our Partnership with CHA Medical Group
PAREXEL Introduces Jamie Macdonald as Chief Executive Officer
Understanding different stakeholder requirements throughout commercialization
Development considerations: Comparing major markets including US, EU, Japan and China
Risk and Common Mistakes in Import and Export Documentation for Clinical Trials
Operational Aspects Of Independent Reviews for Immune-Oncology Clinical Endpoints
PAREXEL Academy Introduces New Collaboration to Develop Japan’s Biopharmaceutical Workforce of the Future
The Evolution of Randomization and Trial Supply Management Services
Exploring ways to enhance evidence generation & communication planning
FDA initiatives under 21st Century Cures Act
Seamless dataflow with a clinical Metadata Repository
PAREXEL Introduces Peyton Howell as Chief Commercial & Strategy Officer
Effective Regulatory Strategies for China Market Entry
Leveraging Imaging And Wearable Technology For Agile Trial Conduct
Increased Internal Collaboration is a Prerequisite for Improved Value Communication
Communicating Product Value for Success: Every Word Counts
The increasingly important role of RWE in CE modeling
Industry Experts Gather at PAREXEL for 2018 ISPE Investigational Products Community of Practice Symposium
Effective Strategies for Successful Global Development
Trends in Early Development
Understanding regulatory and payer requirements throughout commercialization
PAREXEL’s Xavier Flinois, 2018 PharmaVOICE 100 Honoree, Discusses Technological Innovation in Drug Development
Catalyst For Transformation
agile-IRT
Agile IRT
Reduced Timelines
Simpler Processes
Expert Services
Contact
test
Graduate | PAREXEL
Menu
Home
>
parexel-insights
>
Navigating Regulatory Submissi...
