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Real World evidence

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[FREE] HEALTH DATA MANAGEMENT GUIDE :

MANAGE YOUR TRIAL DATA

Step by step guide to understand how to collect, manage & analyze reliable data from your trial.

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your study within 4 steps

Adaptive methods, Precise Execution
2

study set-up

Data collection tools review as part of a cross-functional team to ensure that data is collected:
  • In a clear and concise manner for the investigator
  • Efficiently for Data Management processing
  • Optimally for statistical analysis
Complete Data Management documentation creation, review and distribution
  • Data Management Plan (DMP)
  • Completion guidelines
  • Data Validation Plan (DVP)
  • SAE Reconciliation Plan
  • Specific reports
  • Data transfer protocol
Computerized system
  • Design: Annotatation, Development specifications creation and validation
  • Extensive testing and validation experience
  • Documentation
  • Training
3

in life study progress

Data life cycle
  • Cleaning, validation and discrepancies management
  • Holistic review for data quality and data acceptance
  • Data transfer
  • Interim database lock
Computerized system
  • User account creation and management
  • Change control management
  • Change control management
  • Refresher training
Reported terms management
  • Advers Events coding
  • Serious Adverse Events reconciliation
Data Management documentation
  • Update and maintenance
Study follow-up
  • Standard and custom reports
  • Standard and custom dashboards
4

Study End

Data end point
  • Final discrepanties management
  • Final quality control
  • Final accuracy audit
  • Final database transfer
Data Management documentation
  • Final database lock request form completion and validation
  • Final Database lock form completion and validation
  • Final Data Management Report
  • Archiving
Computerized system
  • Final database lock request form completion and validation
Reported terms management
  • Final Advers Events Coding
  • Final Serious Adverse Events reconciliation
Database final lock

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Words From Our Sponsors
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Nadia is a wonderful person. She is very talented and dedicated to give her experience to the service of others.

As my line manager, I truly appreciated to work with her. She has all the qualities of a manager you dream of: charismatic, experienced, trustworthy, devoted, organized, positive and benevolent.

She has excellent communication, problem-solving skills and has a remarkable ability to solve any complex situations thanks to her extremely wide expertise (data-management, management, IT and audit). Her reliability, strong expertise, diligence and hard-working abilities are an incontestable asset for an oriented-services work. On top of her strong expertise, Nadia is birght, intelligent and a very pleasant and king person to work with.

I would really appreciate to work with her again soon and I highly recommend her.

Anna PROK - TIEVDirector, Clinical Data Management chez Kantar

I had the pleasure of working with Nadia and the Focus Data Science team on a project in which they developed a web-based system to collect survey data from hospitals. Nadia was approachable and professional, and was very thorough in outlining the project plan and technical details.

The final product was of high quality, and my client commented on how impresssed they were with the overall look-and-feel and functionality of the interface.

A job well done!

Robert Hutcheson, MSc, PMPSenior Manager at Certara Evidence & Access

Travailler avec Nadia a toujours été un plaisir! Sa rigueur et son professionnalisme mènerons à bien tous vos projets en DM et en IT.

Gwladys GourdeauData manager (prestation L'Oréal) chez IT&M STATS

Nadia est professionnelle, rigoureuse, impliquée et généreuse. Elle sait motiver et transmettre pour avancer et se surpasser. Travailler à ses côtés a été une excellente expérience!

Céline KernaleguenSenior Data Manager chez stève consultants
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