Clinical data management

Metronomia, champions for better data

At Metronomia, we take pride in being champions for better data, ensuring that it is optimally defined, stored, monitored and processed for maximum value in your development portfolio.

Our people, processes and technology ensure that your data is:

  • Of the highest quality and precision, meeting or surpassing requirements and gold standards
  • Precisely monitored within a fluid feedback-loop allowing identification of risks/mitigations and opportunities
  • Protected and secured in a capsulated environment
  • Ready to pass when put to the test by regulatory agencies
  • A commodity in your clinical development portfolio by achieving its full potential

With a full range of clinical data management services, Metronomia’s data managers are your experts for:

  • Clinical studies of all sizes and all phases
  • New/existing drugs and medical devices
  • Stand-alone projects or complete clinical development programs
  • Outsourced data management acting fully as your data management representatives or as an extension of your own data management team

Your Single Data Center collaborating in unison with our Biostatistical group. Allow us to share our success stories, made possible by unsurpassable agility and dedication! Contact us for an appointment or references!

Clinical data management services comprise

Project Management and oversight
  • Outsourced Clinical Data Project Managers & Data Quality Control Managers
  • Clinical Development Portfolio, Program/Plan or Protocol consultation
  • Vendor Management & Oversight
  • Technology Solutions Consulting
  • Risk-Based Monitoring Strategies
  • Trial Master File Management
CRF design and validation
  • CRF/eCRF Design & Development
  • CRF/eCRF Annotation & Review
  • Database Design and Validation
  • Edit check programming, validation, and testing, UAT
  • Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient Reported Outcome (ePRO) Design, Development & Validation
  • Set-up for targeted / selective SDV
  • Custom Dashboards and Reports
EDC services
  • 24/7 EDC helpdesk
  • eCRF access and user management
  • Development of training material, eCRF user manuals and completion guidelines
  • eCRF self-training, live-training and train–the-trainer
  • SAE reporting in E2B format
  • Integration with third-party eDiary/ePRO systems
  • Integration with third-party CTMS systems
Management of external data
  • Import, reconciliation, and cleaning of all types of electronic data (lab, ECG, PK, eDiary, photo etc.)
  • Patient diary and PRO data management
  • Local lab data management
Day to day clinical data management
  • Continuous data review & validation
  • Data cleaning & query management
  • Serious Adverse Event (SAE) Reconciliation
  • Medical / Manual / SAS® Data Listings Review
  • Medical coding (MedDRA, WHO-DD or client’s dictionary)
  • SAE reconciliation between safety and clinical databases
  • Real-time data viewing and reporting
  • Database snapshots, soft & hard lock
Data management documents and deliverables
  • Data Management Plan
  • Data Validation Plan
  • CRF Completion Guidelines (CCG) Development
  • Data archival and storage
  • Data export & transfer
  • CDISC CDASH and SDTM compliant deliverables
“Paper” process
  • Systems and SOPs still available and maintained for high quality paper process
  • Serving strong demand for hybrid studies – eCRF plus paper-PROs or mixed paper- and e-PROs
  • Supporting paper CRFs and paper-based PROs
  • Data processing through double data entry
  • Independent verification – data entry QC
Systems
  • Quadratek’s Clincase EDC solution, including fully integrated eCRF, ePRO, targeted SDV, IRT, and randomization (preferred partnership)
  • Medidata RAVE
  • Access to other EDC solutions
  • seeWise for data visualization and medical monitoring & review support
Biological data processing

read more about our non-clinical services.

  • Processing of in vitro or in vivo raw data and large complex data sets in an evaluable and publishable form: tables, graphs, presentations
  • Data visualization
  • Processing data in SEND format
  • Biological data management and set-up of databases for non-clinical data

Clincase

At a glance

  • Powerful and comprehensive EDC solution
  • >10 years in use at Metronomia
  • 21 CFR Part 11 compliant, inspected and often audited
  • very user friendly, easy to use

Dashboard Features

  • Drill down reporting with export to PDF and Excel
  • Real-time data sync with EDC
  • Comprehensive chart library
  • Configurable to study
  • Mobile responsive
Dieter Meyer

„For over 30 years, Metronomia has been a great home for our employees and, equally as important, for our customers’ data. Try us – you won’t regret it!”

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