Site-based observational research has many challenges. Considerable time and cost is invested in identifying suitable sites and investigators, and then managing them to ensure recruitment and research are conducted in line with the protocol and local review board requirements. Furthermore, there is considerable burden to subjects - they may have to travel a distance to research sites to attend lengthy appointments, resulting in out-of-pocket expenses, lost time and inconvenience.

1. GOING VIRTUAL: EVOLVING
REAL-WORLD EVIDENCE
(RWE) STUDY DESIGN
Evolving from Site-Based to Virtual RWE (vRWE)
Site-based observational research has many challenges. Considerable time and cost is invested in
identifying suitable sites and investigators, and then managing them to ensure recruitment and research
are conducted in line with the protocol and local review board requirements. Furthermore, there is
considerable burden to subjects – they may have to travel a distance to research sites to attend lengthy
appointments, resulting in out-of-pocket expenses, lost time and inconvenience.
How might the current site-based model for observational research be improved? One approach is to eliminate
sites and their investigators from a study altogether, and move to a vRWE model in which:
▶▶ Patients are recruited, managed, and supported centrally through an online portal and call center
▶▶ Samples are collected locally at storefront laboratories
Comparing these approaches (Table 1), vRWE may have benefits for both research sponsors and patients.
Table 1. Site-Based Research vs vRWE
Site-Based Research vRWE
▶▶ Recruitment tied directly to quality of
site and investigator
▶▶ Limited to geography of sites
Recruitment ▶▶ Broader spectrum of sources
available for patient identification
▶▶ Ability to recruit subjects nationally
▶▶ One principal investigator per site
▶▶ Site initiation visit and training
required
▶▶ Contracts and management required
for all sites
▶▶ Study coordinator required
Site
Management
▶▶ Central principal investigator for
entire study
▶▶ No site initiation visit and training
required
▶▶ Site management costs virtually
eliminated
▶▶ Study coordinated via call center
▶▶ Local IRB processes
▶▶ In-person consent
IRB and Consent ▶▶ Central IRB process
▶▶ Virtual eConsent
▶▶ On-site monitoring required Site/Data
Monitoring
▶▶ Remote data review only
▶▶ Paper and Case Report Forms Data Collection ▶▶ Electronic data portal
▶▶ On-site enrollment and study visits
▶▶ Travel to site may be substantial
Subject
Convenience
▶▶ Enrollment conducted from home
▶▶ Subjects recruited close to local
laboratories

2. vRWE Framework
Covance’s vRWE research model (Figure 1) offers an alternative approach for collection of real-world
data, relying on virtual recruitment, established patient-centric call centers, >1,700 LabCorp labs across
the U.S., and industry-leading bioanalysis services. Covance Market Access consultancy teams help
clients to design and implement observational studies and analyze and communicate findings.
Figure 1. vRWE Framework
vRWE: Appropriate Use Cases
Subject
Identification
Data
Management
& Analysis
Enrollment
Complete
Visit to Local
LabCorp lab
eConsent Portal
Covance Central Labs
Covance Call Center
Covance
Bioanalysis Lab
External Lab
Pre-Screening
Analysis
Enrollment
LabCorp Visit and Sample Analysis
1
4
2
3
as required
Site-Based Research
▶▶ Interventional designs
▶▶ Global studies
▶▶ Studies requiring:
– direct contact with study staff
– frequent or sophisticated data collection
▶▶ Populations requiring investigator-
specific and targeted recruitment
vRWE
▶▶ Virtual registries
▶▶ Electronic clinical outcome
assessment (COA) validation studies
▶▶ Electronic diary data collection
▶▶ Large studies requiring broad geographic
distribution (e.g. burden of illness)
▶▶ Rare disease population studies
▶▶ Supplement to site-based design
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the
marketing name for Covance Inc. and its subsidiaries around the world.
The Americas + 1.888.COVANCE + 1.609.452.4440
Europe / Africa + 00.800.2682.2682 Asia Pacific + 800.6568.3000
© Copyright 2019 Covance Inc. SSCMA047-0519
Learn more about our market access solutions at www.covance.com/marketaccess