The document outlines Covance's expertise in supporting gene replacement therapies and CAR-T therapies, including post-approval solutions and regulatory compliance. With a global presence and a large team of professionals across various disciplines, Covance utilizes advanced technology to streamline case processing and improve patient safety. The document emphasizes their specialized capabilities in precision medicine and cell & gene therapy across the drug development phases.

1. Supported the development of
BOTH
GENE
REPLACEMENT
THERAPIES
FDA approved
CAR-T therapies and helped
advance the first 2 FDA-approved
Real-World Evidence Studies
& Post-Marketing Commitments
Long-term follow-up studies
Disease and product registries
Global presence; deep therapeutic area expertise
~25 Project Managers
Database of 200,000 physicians worldwide
Contacts with regulatory and payers in
key markets
Access to policy, fee schedule payment data
and decision makers
Patient Safety & Pharmacovigilance
1,300+ safety professionals across the U.S., Europe and Asia Pacific
200+ person team of highly experienced safety writing professionals
120+ member team of medical reviewers–case review, aggregate
review and signal management
PV SMEs available locally in each region to provide guidance in
global and local regulations
CELL & GENE THERAPY
Post-Approval Solutions
With specialized expertise, coordinated capabilities and focused
investments across preclinical, clinical and post-approval phases, we’ll help
you to reduce the time and risk in your product’s development.
Processed
in the last
5 years
From intake
and case
processing
automation
Regulatory compliance
achieved in the last 4 years
~2.5M 55% >99.5%
CASES TIME
SAVINGS
Across all product & therapeutic areas

2. Precision Medicine Solutions Designed Around Your Needs
Visit us at www.covance.com/CGT
Covance is a business segment of LabCorp, a leading global life sciences company, which
provides contract research services to the drug, medical device and diagnostics, crop protection
and chemical industries. COVANCE is a registered trademark and the marketing name for
Covance Inc. and its subsidiaries around the world.
www.covance.com
© Copyright 2019 Covance Inc. SSCGT004-0220
Covering a variety of
disciplines
1,500+
CALL CENTER
STAFF
Precision Medicine Solutions Designed Around Your Needs
www.covance.com/CGT
Covance is a business segment of LabCorp, a leading global life sciences company, which
provides contract research services to the drug, medical device and diagnostics, crop protection
and chemical industries. COVANCE is a registered trademark and the marketing name for
Covance Inc. and its subsidiaries around the world.
© Copyright 2019 Covance Inc. SSCGT004-0220
CELL & GENE THERAPY
Post-Approval Solutions
Patient & Field Support
Field reimbursement
Clinical education
Payer and customer relations
120+ field team members and 300+
clinical educators (U.S.)
Non-commercial pharmacy
CMC Analytical Testing
Routine global lot and release and
stability testing
Out of Scope/Out of Trend data
trending and alerts
Long-term stability testing
Manufacturing comparability
Regulatory & Strategic Product
Development Consulting
Differentiation studies
Label/indication expansion
Combination strategy
Health economics
Per year for commercial
product (all product &
therapeutic areas)
900+
RELEASE EVENTS
Supporting regulatory
consulting, submissions
management and project
management
180STAFF