PPD LABORATORIES Central Lab · 2020-04-30 · THE ENTIRE PROJECT TEAM + The Preclarus® central...

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REAL-TIME ACCESS TO CLEAN DATA FOR THE ENTIRE PROJECT TEAM+ The Preclarus® central lab databse, PPD

Laboratories’ proprietary laboratory information system, creates a single, web-based global database that eliminates the need for integration of regional datasets

+ Central lab dashboards summarize integrated data to facilitate project oversight from start to finish

+ The Preclarus lab data portal, investigator site portal and a mobile app provide secure, real-time access to studywide data

ONE GLOBAL DATABASE

PPDOF HALLMARKS

+ Single global database allows PPD Laboratories to test regionally and combine data globally

+ Inherently combinable data so results accurately reflect biological variation

+ Real-time data cleansing saves hundreds of hours at the end of the trial

+ 10 globally validated platforms+ Unique Global Laboratory Assay Standardization Survey

(GLASS) verifies accuracy and global standardization

SERVICES

Helping clients understand the safety and efficacy of their drug in patients

Data file to project

teamTest results to investigator for patient management

Patient specimens sent to lab

Diagnosis and treatment per protocol

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INCLUSION TESTING+ Initial testing for patient acceptance into trial+ Baseline chemistry, urinalysis and hematology+ Drugs of abuse screening+ Infectious disease, biomarkers or other screening

tests where appropriate

SAFETY & EFFICACY TESTING

+ Status of bodily functions via routine chemistry, urinalysis and/or hematology

+ Status of disease state utilizing protocol-specific testing

+ Adverse event monitoring per protocol

EXPLORATORY BIOMARKER STUDIES+ Not typically used for patient management+ Include various ‘omics methodologies

(e.g., genomics, proteomics, metabolomics)

CENTRAL LAB+ Multiple visits per trial protocol+ Data and samples collected to

measure the e�ects of the drug in the patient

PATIENT

INVESTIGATOR

CLIENT

Visit one to conclusion of trial

CENTRAL LAB

5 Weeks from final protocol to kits on site

4 Regional locations

3 Sites building custom kits

2 Million+ samples tested per year

1 Global Database

©2020 PPD, Inc. All rights reserved.

FACTSTHE

MINISTRY OF HEALTHSINGAPORE GOVERNMENT

OF CHINA

Central LabPPD® LABORATORIES

HELPING DELIVER LIFE-CHANGING THERAPIES