Cystic fibrosis drug development faces major challenges including a limited worldwide patient population that makes recruitment difficult, the need for specialized trial sites, and the complex nature of the disease. Covance has experience conducting over 20 cystic fibrosis studies and can help overcome these challenges through their relationships with patient advocacy groups to enhance enrollment, expertise in locating optimal specialized sites, and experience designing studies that accommodate the needs of pediatric and adult cystic fibrosis patients.

1. CYSTIC FIBROSIS DRUG
DEVELOPMENT PAIN POINTS
CYSTIC FIBROSIS
DRUG DEVELOPMENT SOLUTIONS
Succeed in Cystic Fibrosis Studies With
an Experienced and Trusted Partner
CF remains one of the most common life-shortening inherited diseases, despite
breakthroughs in targeted therapies in recent years. Research and development efforts
continue, but those involved face major challenges in finding specialized trials sites and
enrolling sufficient numbers of eligible patients.
► There are only around 75,000 CF patients
worldwide (patients with different
mutations), and this limited population
creates challenges for recruitment
► Patient advocacy groups such as the
Cystic Fibrosis Foundation (CFF) are highly
involved in reviewing study protocols and
work extremely closely with CF patients,
meaning good relationships between these
groups and industry are crucial
► The unique and complex nature of CF
means that specialized sites are needed,
increasing competition for optimal sites
► CF patients and families are often
well‑informed and require more detailed
information than usual about their
potential study
► Patients may be pediatric or adult and
their disease often impacts multiple organ
systems, thus multidisciplinary trial teams
are required
UNMET MEDICAL NEEDS IN CYSTIC FIBROSIS
CF is a multi-organ disease
and therefore patients are often
undergoing multiple treatments,
with long concomitant medication
lists even for pediatric patients
Managing the CF lung disease
is resource-intensive (time, effort)
and requires a lifelong commitment
from both patient and caregiver
Management of
pulmonary exacerbations in
CF patients is suboptimal

2. Learn more about our drug development solutions at www.covance.com
Covance Inc., headquartered in Princeton, NJ, USA is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is registered trademark and the
marketing name for Covance Inc. and its subsidiaries around the world.
The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440
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CYSTIC FIBROSIS
DRUG DEVELOPMENT SOLUTIONS
Overcome Cystic Fibrosis Study Challenges
with Covance Solutions
Since 2012, Covance has conducted 20 CF studies, and we employ 1,500 staff with respiratory experience,
including >650 clinical research associates and >195 project managers. Our staff are specifically trained
to support CF site teams, and work across several client protocols simultaneously to ensure consistency.
We hold expertise in many specialized tests, including pulmonary function testing, sweat chloride testing,
genotyping of different CF mutations, patient‑reported outcomes (PRO) and questionnaires, and sputum
sampling and processing for biomarkers assays, microbiology and cytology.
REACHING RECRUITMENT TARGETS
► Covance develops protocols that fulfill expectations of the CFF and other
advocacy groups, who are highly involved in informing patients about clinical
trials – working with CF patient advocacy organizations ensures enhanced
patient enrollment
► We support patients and families using patient-centric modeling to design
trials that accommodate their needs
► We provide detailed study information with a CF study-specific patient platform
LOCATING OPTIMAL TRIAL SITES
► Our prior experience in CF studies allow us to engage new sites and rapidly
align them to the high performance required
► Xcellerate®
Trial Design leverages data in the Covance clinical trial
knowledgebase, which houses >40% global trial data at any one time – this
real-world data can be used to match areas of high patient density with the
location of high-performing investigators to find optimal trial sites
► Covance has long-standing relationships with specialized CF trial sites
OVERCOMING CF TRIAL CHALLENGES: A FOCUS ON PEDIATRIC PATIENTS
Development challenges Covance solutions
Conforming to current pediatric
regulations
► Expertise in pediatric protocol design and implementation
► Formulation of a pediatric development plan and engagement of
regulatory agencies early in development process
Maintaining pediatric patient
compliance
► Understanding patient challenges using voice of patient and/or parent
insights, and incorporating these insights into trial design
► Site infrastructure to support the needs of patients and their families