Unleash the Power of Your Data™

from Laboratory Testing

Providing clinical biometrics for the biopharma, medical device,

and diagnostic industries.

www.pharmapace.com

We are located in the heart of the

pharmaceutical and biotechnology hub in San Diego, California

(858) 263-0510wxc_sandiego_info@wuxiapptec.com

10509 Vista Sorrento Parkway, Suite 303San Diego, CA 92121

www.pharmapace.com

or contact your local WuXi LTD Business Development Representative

Our Core Business

Numerous Medical

Disclosures

> 30 Regulatory

Submissions

6 Database Integrations

> 200 Studies

with CDISC

> 20 NDA & sNDA

Approvals

Accomplishments

Clinical Trial Biometrics

Outsourcing

Statistical Consulting

Global Integrated Database

(GIDB)

Regulatory Submission

Data & Analysis Rescue

WuXi LTD is proud to

partner with

DMPK

Cut Point

Low Positive Control (ADA)

Clinical Biometric Expertise

Analytical Focus Secure Data

Our Mission is to deliver exceptional value in

statistical consulting and data analyses

outsourcing for your development programs.

We specialize in:

Clinical Development Strategy

Clinical Study Design

Statistical Analysis Plan

Database Construction, Analysis, and Reporting

Data Mining and Analysis for Publication

CDISC (SEND, CDASH, SDTM, & ADaM)

Data Management

Medical Publications

Clinical Study Reports

Project Management

PK/PD

Dose-Finding

Type C mtg

IND

CRM

Variability

Dose & Formulation Optimization

PK/PD

Dose-Finding

Briefing Doc

EOP2

tQT Studies

Meta-Analyses

Adaptive Design

Sample Size Re-Estimation

Pre-CTD mtg

CTD Planning/ Submission

ISE/ISS

Regulatory Response

Briefing Doc

Ad-Hoc Analysis

Draft Label

Core Data Sheet

Publications

Phase 4 Trials

Data Mining

Data Integration

Periodic Safety Reports

Observational Database Analysis

AMCP Dossier

sNDA

Pharmapace offers in-depth experience for your company’s clinical trial data, analyses, and regulatory submissions.

Your data and information are secure at Pharmapace. Our centralized facilities offer:

Daily Backup & Secure Cloud Storage

Weekly Backup of Sever Structure

Central & Validated SAS Computing

Secure SharePoint FTP

Private Secure Servers

Secure Email System

21 CFR Part 11 Compliant

Rare Disease

Ophthalmology

Gastroenterology

Phase 1 Phase 2 Phase 3 Post Approval

Oncology

Immunology/ Infectious

Disease

CNS

Endocrine/Metabolic

NASH/NAFLD

Data Management Support

Analytical