• 2390 Faraday Ave, Carlsbad, CA 92008 USA
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    +1-858-779-9933 / +1-619-821-8190 icon

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    info@rpmalliance.com

EDC Expertise

EDC Expertise

We have expertise in all major and secure 21 CFR Part 11-compliant EDC systems available in the industry, being proficient with its extensive user interface for successful management of studies. We are flexible working in multiple EDC systems, depending on client preference. Combining years of experience within the clinical research industry standards and best practices, we provide unmatched support that organizations need from beginning to end including form design, study build and implementation in compliance with data and industry standards.

We have been consistently providing high quality clinical operation services, secure hosting and data management functionalities that meet our clients' need. We pride ourselves in providing one of the finest technical and user support teams available in the clinical research industry. With an experience of successfully completing hundreds of clinical trials, our experienced and trained clinical professionals have an extensive and robust knowledge base that comes from many years of experience to answer all potential clinical operations and study concerns.

We provide quality data preventing budget and timeline overruns. We are known to offer all our clients simple and efficient technology-quality outcome that supports both EDC and clinical data management system (CDMS) functionalities. Our experienced workforce integrate data management SOPs and customizable workflow seamlessly following all the data management steps efficiently for successful project execution.

We also develop comprehensive and flexible clinical trial and EDC training programs designed and customized for every sponsors' needs empowering better decision making.

We are proficient in rapid deployment, flexible study configuration, swift change management and experienced user support. We have an experienced workforce including Project Managers, Database Coordinators, Database Managers, Data Reviewers Team for UAT and System Administrators to maintain the entire EDC process for our clients. RPM Alliance ensures analysis-ready data at any time for all phases of trials.

Our EDC services include:

  • Expertise in configuring CRFs
  • Maintaining CDISC standards
  • Study set-up
  • Programming that includes both hard and soft checks, workflows etc
  • Source document verification (SDV) requirements
  • Full support for paper and hybrid studies
  • Real-time edit checks—including cross CRF’s/events across visits and panels
  • Blinding
  • Trial protocol and on-line help
  • Data export into SAS format
  • Database export and lock
  • Mid-study changes
  • Clinical monitoring remote support
  • Data extraction
  • Input from Data Management team
  • Data entry
  • Dictionary coding
  • QA / QC processes
  • Handling multiple CRF versions
  • User support, guidance and supervision for inexperienced sponsor EDC teams
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