Dec 16, 2019   SOURCE: PR NewsWire

Site Start Up Report 2019: Study Sponsors, CROs, SMOs, Clinical Trial Sites

DUBLIN, Dec. 16, 2019 /PRNewswire/ -- The "Site Start Up: Best Practices For Success" report has been added to ResearchAndMarkets.com's offering.

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It will come as a surprise to no one that site start up is a challenging part of the clinical trial process. Various pieces of research into this topic have put the length of site start up (site selection through activation) in the ballpark of 7 to 10 months. In the pharma world, with patent cliffs and competitor products looming, each day is valuable and every delay is costly.

For this research, we gathered verbatim insights into the practices that create site start up efficiency, the causes of inefficiency, and new practices being undertaken in an effort to improve efficiency. To get multiple perspectives on the site start up process, we surveyed people with a site start up responsibilities at sponsors and CROs as well as people working at clinical sites, such as clinical investigators and study coordinators.

We asked our respondents to provide thoughtful looks into the challenges and best practices they associate with seven different steps of the site start up process. This report shares actionable practices to improve site start up efficiency.

What You Will Learn

Study Sponsors, CROs, and SMOs

    --  Which steps of the site start up process are considered the most
        problematic among both sponsor/CRO respondents and site personnel
    --  Practices that our respondents strongly believe are critical for
        improving efficiency or fixing inefficiencies
    --  How industry peers track startup performance
    --  Strategies that start up professionals say are working, strategies that
        have failed, and what they're working on next to improve efficiency

Clinical Trial Sites

    --  Insight into the site start up activities that study sponsors and CROs
        are most actively working on to improve their efficiency
    --  How sponsors and CROs feel about working with SMOs in regards to
        increasing start up efficiency
    --  Advice to sponsors and CROs for how to improve start up speed
    --  Best practices for improving study start up speed used by investigators
        and study coordinators

Major Topics

    --  Site Start Up Challenges
    --  Verbatim Analysis: Causes of Efficiency/Inefficiency and New Practices
        Planned
    --  Site Start Up Strategies and Performance Measurement
    --  Sponsor and CRO Site Start Up Performance
    --  Study Data: Sponsors/CROs
    --  Study Data: Sites

Key Topics Covered

Introduction

Methodology

6 Major Sections

Site Start Up Challenges

    --  Primary Section Takeaways
    --  Most Problematic Site Start Up Activity - Sponsors/ CROs
    --  Most Problematic Site Start Up Activity - Site Personnel
    --  Sponsor/CRO Site Start Up Improvement Areas
    --  Sponsor/CRO perspective
    --  Site Perspective
    --  Sites' Start Up Improvement Areas

Verbatim Analysis: Causes Of Efficiency/Inefficiency And New Practices Planned

    --  Section Introduction
    --  Primary Section Takeaways
    --  Site Selection (including Site Feasibility)
    --  Pre-study Site Visits
    --  Regulatory Agency/Competent Authority Approval
    --  IRB/Ethics Approval
    --  Document Collection
    --  Site Contract and Budget Negotiation
    --  Site Initiation/Activation
    --  Site Start Up Strategies and Performance Measurement
    --  Primary Section Takeaways
    --  Frequency of Performing Start Up Strategies - Sponsors/CROs
    --  Impact of Start Up Strategies - Sponsors/CROs
    --  Frequency of Sponsors/CROs Performing Start Up
    --  Strategies - Site Personnel
    --  Impact of Sponsor/CRO Start Up Strategies - Site Personnel
    --  Use and Efficiency of Site Management Organizations
    --  Use and Effectiveness of Specialized Site Start Up Companies
    --  Measuring Start Up Performance

Sponsor And Cro Site Start Up Performance

    --  Primary Section Takeaways
    --  Large CRO Performance vs. Expectations - Rated by Sponsors
    --  Non-large CRO Performance vs. Expectations -
    --  Rated by Sponsors
    --  Large vs. Non-Large CRO Performance - Rated by Sponsors
    --  Sponsor Performance vs. Expectations - Rated by Site Personnel
    --  CRO Performance vs. Expectations - Rated by Site Personnel
    --  Sponsor vs. CRO Performance - Rated by Site Personnel

Study Data: Sponsors/CROS

    --  Most Problematic Start Up Activity
    --  Rationale for Most Problematic Start Up Activity
    --  Site Selection (including Site Feasibility)
    --  Pre-study Site Visits
    --  Regulatory Agency/Competent Authority Approval
    --  IRB/Ethics Approval
    --  Document Collection
    --  Site Contract and Budget Negotiation
    --  Site Initiation/Activation
    --  Start Up Improvement Areas
    --  Site Selection (including Site Feasibility)
    --  Practices Improving Start Up Efficiency
    --  Practices that Create Start Up Inefficiency
    --  New Practices Planned to Improve Efficiency
    --  Pre-study Site Visits
    --  Practices Improving Start Up Efficiency
    --  Practices that Create Start Up Inefficiency
    --  New Practices Planned to Improve Efficiency
    --  Regulatory Agency/Competent Authority Approval
    --  Practices Improving Start Up Efficiency
    --  Practices that Create Start Up Inefficiency
    --  New Practices Planned to Improve Efficiency
    --  IRB/Ethics Approval
    --  Practices Improving Start Up Efficiency
    --  Practices that Create Start Up Inefficiency
    --  New Practices Planned to Improve Efficiency
    --  Document Collection
    --  Practices Improving Start Up Efficiency
    --  Practices that Create Start Up Inefficiency
    --  New Practices Planned to Improve Efficiency
    --  Site Contract and Budget Negotiations
    --  Practices Improving Start Up Efficiency
    --  Practices that Create Start Up Inefficiency
    --  New Practices Planned to Improve Efficiency
    --  Site Initiation/Activation
    --  Practices Improving Start Up Efficiency
    --  Practices that Create Start Up Inefficiency
    --  New Practices Planned to Improve Efficiency
    --  Likelihood of Efforts Improving Start Up Efficiency
    --  Frequency of Performing Start Up Strategies
    --  Impact of Start Up Strategies
    --  Advice to Improve Site Start Up Efficiency
    --  Use of Site Management Organizations
    --  Site Management Organization Efficiency
    --  Use of Specialized Site Start Up Companies
    --  Effectiveness of Specialized Site Start Up Companies
    --  Value Added via Specialized Site Start Up Companies
    --  Start Up Performance Benchmarks
    --  Start Up Performance Measures
    --  Service Provider Use
    --  Service Provider Performance Relative to
    --  Expectations
    --  Accel
    --  Accelovance
    --  Advanced Clinical
    --  Bioclinica
    --  Clinical Research Services (CRS)
    --  Clinipace
    --  Clinlogix
    --  Clintec
    --  Covance
    --  DaVita Clinical Research
    --  DCRI-Duke
    --  Eurofins
    --  Eurotrials
    --  Frontage
    --  ICON
    --  IQVIA
    --  Lambda
    --  Medpace
    --  NAMSA
    --  Novotech
    --  PAREXEL
    --  PPD
    --  PRA
    --  Premier Research
    --  PSI
    --  QPS
    --  Quanticate
    --  SGS Life Sciences
    --  Syneos Health
    --  SynteractHCR
    --  Worldwide Clinical Trials

Study Data: Sites

    --  Most Problematic Start Up Activity
    --  Rationale for Most Problematic Start Up Activity
    --  Site Selection Activities (including Site Feasibility)
    --  Pre-study Site Visits
    --  Regulatory Agency/Competent Authority Approval
    --  IRB/Ethics Approval
    --  Document Collection
    --  Contract and Budget Negotiation
    --  Site Initiation/Activation
    --  Sponsor/CRO Start Up Improvement Areas
    --  Sites' Start Up Improvement Areas
    --  Site Selection Activities (including Feasibility)
    --  Sponsor/CRO Practices that Improve Start Up Efficiency
    --  Sponsor/CRO Practices that Create Start Up Inefficiency
    --  Sites' Best Practices to Improve Efficiency
    --  Pre-study Site Visit
    --  Sponsor/CRO Practices that Improve Start Up Efficiency
    --  Sponsor/CRO Practices that Create Start Up Inefficiency
    --  Sites' Best Practices to Improve Efficiency
    --  Regulatory Agency/Competent Authority Approval
    --  Sponsor/CRO Practices that Improve Start Up Efficiency
    --  Sponsor/CRO Practices that Create Start Up Inefficiency
    --  Sites' Best Practices to Improve Efficiency
    --  IRB/Ethics Approval
    --  Sponsor/CRO Practices that Improve Start Up Efficiency
    --  Sponsor/CRO Practices that Create Start Up Inefficiency
    --  Sites' Best Practices to Improve Efficiency
    --  Document Collection
    --  Sponsor/CRO Practices that Improve Start Up Efficiency
    --  Sponsor/CRO Practices that Create Start Up Inefficiency
    --  Sites' Best Practices to Improve Efficiency
    --  Contract and Budget Negotiations
    --  Sponsor/CRO Practices that Improve Start Up Efficiency
    --  Sponsor/CRO Practices that Create Start Up Inefficiency
    --  Sites' Best Practices to Improve Efficiency
    --  Site Initiation/Activation
    --  Sponsor/CRO Practices that Improve Start Up Efficiency
    --  Sponsor/CRO Practices that Create Start Up Inefficiency
    --  Sites' Best Practices to Improve Efficiency
    --  Likelihood of Efforts Improving Start Up Efficiency
    --  Frequency of Sponsors/CROs Performing Start Up Strategies
    --  Impact of Sponsor/CRO Start Up Strategies
    --  Advice to Sponsors/CROs to Improve Site Start Up Efficiency
    --  Use of Specialized Site Start Up Companies
    --  Effectiveness of Specialized Site Start Up Companies
    --  Value Added via Specialized Site Start Up Companies
    --  Experience with Service Providers
    --  Service Provider Performance Relative to Expectations
    --  Bioclinica
    --  Covance
    --  Eurotrials
    --  ICON
    --  IQVIA
    --  Medpace
    --  PAREXEL
    --  PPD
    --  PRA
    --  Premier Research
    --  Syneos Health
    --  Experience with Sponsors
    --  Sponsor Performance Relative to Expectations
    --  AbbVie
    --  Allergan
    --  Amgen
    --  AstraZeneca
    --  Eli Lilly
    --  Ferring
    --  Johnson & Johnson
    --  Novartis
    --  Novo Nordisk
    --  Otsuka
    --  Pfizer
    --  Roche
    --  Sanofi
    --  Teva

Sponsor/CRO Demographics

    --  Company Type
    --  Office Location
    --  Job Level
    --  Job Title
    --  Decision-making Responsibility
    --  Trial Involvement by Phase
    --  Site Start Up Responsibilities
    --  Clinical Site Demographics
    --  Organization Type
    --  Office Location
    --  Work at Clinical Research Site
    --  Types of Trials Supported
    --  Recency of Phase II/III Involvement
    --  Primary Role
    --  Site Start Up Responsibilities
    --  Therapeutic Areas of Phase II/III Trials

For more information about this report visit https://www.researchandmarkets.com/r/6vdnux

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