Site Start Up: Best Practices For Success

Description

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 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.

Preview-2019-Site-Start-Up-Best-Practices-for-Success

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 start up 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
  • 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

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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)
Pre-study Site Visits
Regulatory Agency/Competent Authority Approval
IRB/Ethics Approval
Document Collection
Site Contract and Budget Negotiations
Site Initiation/Activation

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)
Pre-study Site Visit
Regulatory Agency/Competent Authority Approval
IRB/Ethics Approval
Document Collection
Contract and Budget Negotiations
Site Initiation/Activation

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

Additional information

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