1. P.O.Box 1491, 1000 W. Valley Rd, Southeastern, PA 19399-1491, USA
Office: 610.572.2623 • Email: info@accuclinglobal.com
www.accuclinglobal.com
~Committed To Quantitative Excellence~
About Us
AccuClin Global Services was established in 2011 to assist the needs of resources
in CROs, pharmaceutical and biotech companies by providing strong project
support for biometric tasks associated with clinical development such as
programming, data management and statistical analysis.
Biostatistics: Ph.D., 15 years of experience working with translational medicine in
early phase clinical trials and extensive experience in clinical trials with
pharmacokinetic (PK)/pharmacodynamic (PD) outcomes.
Data Management Profile: BN, 4+ years hands-on experience as a Data Manager
with a CRO background across multiple therapeutic areas; advanced capabilities in
cleaning database including automatic and manual queries; an excellent coder in
MedDRA and WHODRUG.
Database Programming: An experienced Clinical Database Programmer since 2002,
skilled on EDC platforms including Rave and Oracle RDC; fast turn-around; can
work according to Client’s SOPs requirements.
Statistical Programming: Our team has 5-year-experience on average; perform
productions of Tables, Listings and Figures for Phases 1 through 4 studies.
Case Study 1 (2013): AccuClin staffs were embedded into an internal team of a
CRO to work with the Project Manager to address and resolve outstanding queries
in a longitudinal clinical database. With AccuClin’s support, all queries and
outstanding database issues were quickly resolved and brought to a timely closure
allowing the clinical data to be delivered on time for research analysis and
commercial publications.

2. P.O.Box 1491, 1000 W. Valley Rd, Southeastern, PA 19399-1491, USA
Office: 610.572.2623 • Email: info@accuclinglobal.com
www.accuclinglobal.com
~Committed To Quantitative Excellence~
Case Study 2 (2013): A development-stage biopharmaceutical company in the US
requested through subcontract that AccuClin help with accelerated development of
two EDC databases in a highly restricted timeline. AccuClin rapidly developed,
validated and deployed the EDC databases -- from CRF design to edit checks -- for
both studies in time to meet the client’s tight patient enrollment schedule. Since
then, data for both studies have been successfully received, cleaned and databases
locked with no interruption in client timelines.
Case Study 3 (2014):
A global specialty healthcare company needed urgent assistance of their Phase I
study analysis from an external partner as part of an NDA. For this project,
AccuClin successfully provided all SAS outputs with complete PK/PD parameters
and CDISC data sets on time which were critical for this NDA submission.
Case Study 4 (2014):
Provided full statistical support to a CRO, completed activities included statistical
contributions in protocol review, budget estimate, RBM guidance, SOPs
development and bid defense.
Case Study 5 (2014):
Contracted responsibilities for programming, data analysis, output processing, and
preparation of all data files for Abbreviated New Drug Application (ANDA)
submissions for specific products, including PBE analysis and preparation of
required tables, listings, and graphs.