Industry Provider Profiles Company Type Services
PRL offers full service Central Laboratory capabilities for all
clinical phases of drug and diagnostic device trials conducted in
North America. Combining rigorous, reliable yet flexible systems, a
seasoned operations staff, and our core competency in clinical
laboratory science, PRL provides study success solutions. Our goal
is complete customer confidence in project execution that achieves
protocol compliance, assures subject safety, fully supports
investigator site needs, and delivers exceptional value.
PRL is a private independent reference laboratory offering
services in four business areas including clinical diagnostic
testing, anatomic pathology, medical and forensic toxicology and
clinical trials. PRL has provided central laboratory services for
Phase I through Phase III single site and multi-site North American
clinical studies since 1993.
Our twelve member executive board and director level staff lead
business and financial operations. Professional and scientific
direction is provided by PRL's Pathology section of twenty
members. Founded in 1976 by Pierre W. Keitges, M.D.,1933-1997, PRL
consistently meets operations objectives and goals for growth, with
uncompromising dedication to care and respect for the dignity of
patients. PRL now employs more than 375 professionals and
staff.
PRL Central Laboratory Services
PRL Central Laboratory Services has developed its operations
quality systems for consistent performance in process management,
results accuracy and precision, service reliability and outstanding
client support.
Our QA professionals verify that work processes are controlled
and that procedures conform to accepted industry practice
standards. Regulatory compliance to satisfy FDA requirements is
rigorously maintained.
We safeguard the integrity and assure the availability of
customer study data through comprehensive documentation management
and records retention practices.
Our customers can be confident that PRL will deliver precisely
the results expected.
PRL maintains continuous accreditation and licensure per CAP,
CLIA, and SAMHSA.
PRL provides fully customizable study database configuration.
Our proprietary information system and data management practices
comply with regulatory requirements, and conform to industry
standardization models and methods.
Lab data acquired--correct, complete, secure, and retrievable
for 15 years
Lab data accessible--remote access to view study data
Lab data delivered--printed reports, verbal results
notification, custom electronic data transfer formats
Flexible Reporting Options
Each study has its own data reporting needs. PRL presents test
results according to protocol objectives--in conventional and SI
units, flagged per customer criteria for demographics, reference
values, deltas, toxicity grading, and by visits, and blinded as
specified. Study management reports can be provided as the customer
requires.
Experienced PRL project professionals expedite study startup,
monitor your project from initiation to close-out, and provide site
support and assistance. Protocol requirements documentation
specifies service deliverables, implementation plans and quality
parameters.
Site Supplies and Support
PRL works with you to design study specific specimen kits and
requisitions, and provides detailed collection and processing
instructions. Our process tracks usage and triggers supplies
replenishment. Customer support representatives are available for
site assistance.
Logistics
Transport logistics preserve specimen integrity, allow tracking
control and assure accountability. Specimens are received via
commercial courier Monday through Saturday by 9:00 a.m. central
time. Result reports are delivered via fax, U.S. Postal Service,
and commercial courier.
Our careful preparation and attention to detail means that PRL
is ready to initiate studies on time, respond to service issues
effectively and handle scope changes smoothly.
PRL's credentialed and tenured medical technologists employ
advanced clinical testing systems in a state of the art facility.
Comprehensive quality control and proficiency programs verify
accuracy and reliability. Operations around the clock allow rapid
and flexible results turnaround time.
PRL's extensive menu of safety and specialized clinical
testing is appropriate for protocol requirements in a wide range of
therapeutic areas.
Autoimmune profiles
Chemistry
Coagulation
Cytology
Drug screening
Digital imaging analysis
Endocrinology
Flow cytometry
Hematology
Histopathology
Immunohistochemistry
Immunology
Infectious disease serology
Lipid profiles
Microbiology
PCR
Serology
Surgical pathology
Urinalysis
PRL is able to set up and validate protocol specific laboratory
assessments, or conduct method transfer and validation.
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