Spaulding Clinical Research offers a wide range of award-winning services that are tailored to meet our clients’ individual needs. These full-service solutions are available from protocol development through final report writing.
INTRODUCTION:
First-in-Human (FIH)Thorough QT/Concentration Effect QTSingle and Multiple Ascending Dose Complex Drug/Drug InteractionBioavailability/Bioequivalence (BA/BE)Pharmacokinetic/Pharmacodynamic (PK/PD) Renal ImpairmentBiologic/Biosimilar
TYPES OF STUDIES:
Synopsis/Protocol DesignStudy ConductProject ManagementData ManagementBiostatistics WinNonLin AnalysisPK Parameter AnalysisMedical Writing Regulatory Publishing
SERVICES: SPAULDING CLINICAL’S HEADQUARTERS
200 Bed Clinical Pharmacology Unit 96 Continuous 12-Lead Telemetry Beds 12 Bed First-in-Human SAD/MAD Unit Paperless Study Conduct On-Site Clinical LaboratoryEsource Interface with Multiple Data Platforms, including Medidata Rave
WEST BEND, WI (GREATER MILWAUKEE METRO AREA)
CLINICAL PHARMACOLOGY UNIT
CLINICAL PHARMACOLOGY UNIT
Database of Over 22,000 Active Study Volunteers Population of Over 2 Million People in the Greater Milwaukee Metro Area On-Site Call Center with Dedicated Full-Time Recruiters Effective, Study-Specific Recruitment Strategies
RECRUITING:
Rapid Protocol Development OptionLast Subject Last Visit (LSLV) to Database Lock: 21 Calendar Days Database Lock to Final CSR: 90 Calendar Days Rapid Data Delivery Option: 45 Calendar Days
BIOMETRICS/DATA MANAGEMENT:
525 S. Silverbrook Dr., West Bend, WI 53095 T: +1 (262) 334-6020 E: [email protected] www.spauldingclinical.com
At Spaulding Clinical our fully-integrated, ClinSpark Electronic Source Data Capture system allows us to capture real-time study metrics which we analyze for every trial. At the end of every year, we compile the data. What we find is more than numbers; it’s the transparent quality difference between Spaulding Clinical and our competition.
2019 METRICS:
2019 Metrics
Heart Rate SD
1.98 bpm 2.85 msQTcF SD
100%
100%
99.3%
98.5%
99.9%
98.1%
Studies Fully Enrolled On-Time (NHV)
Subject Retention
Drug Dose On-Time
PKs On-Time (Protocol Window)
PKs On-Time (2 min. Standard Window)
ECG Quality Rating
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