CLINICAL PHARMACOLOGY UNIT - …€¦ · CLINICAL PHARMACOLOGY UNIT Database of Over 22,000 Active...
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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 QT Single and Multiple Ascending Dose Complex Drug/Drug Interaction Bioavailability/Bioequivalence (BA/BE) Pharmacokinetic/Pharmacodynamic (PK/PD) Renal Impairment Biologic/Biosimilar TYPES OF STUDIES: Synopsis/Protocol Design Study Conduct Project Management Data Management Biostatistics WinNonLin Analysis PK Parameter Analysis Medical 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 Laboratory Esource Interface with Multiple Data Platforms, including Medidata Rave WEST BEND, WI (GREATER MILWAUKEE METRO AREA) CLINICAL PHARMACOLOGY UNIT
Transcript of CLINICAL PHARMACOLOGY UNIT - …€¦ · CLINICAL PHARMACOLOGY UNIT Database of Over 22,000 Active...
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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
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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
