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DATA MANAGEMENT & BIOSTATISTICS

Data Management & Biostatistics

Preclinical Through Post-Market Capabilities

ClinActis’ Data Management expertise includes preclinical development guidance through regulatory filings and post-marketing studies. Our team and partners can work with small to mid-sized companies as well as being a reliable resource to large pharma and medical device companies seeking to outsource specialized tasks for timely completion.

SOPs and Technology To Ensure Safety and Data integrity

To ensure the safety and integrity of our clients’ data, ClinActis utilizes SOPs compliant with ICH and GCP technology standards for clinical research. Our staff and partners consist of IT specialists to sustain the validation, reliability and functionality of our systems. We dedicate significant resources to our technology because of its importance to the accuracy of our client’s data. Systems our team is familiar with include:

 

  • EDC Oracle Clinical Data Management

  • Technology Data Sheets

  • Oracle Clinical Remote Data Capture

  • Oracle Argus Safety

  • LORENZ docuBridge®

  • Microsoft SharePoint-Montrium

  • SAS

  • nQuery

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