data
management
We collect and process data to guide decision makers through health progress.
[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.
your study within 4 steps
Adaptive methods, Precise Execution
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
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
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
your study, without anxiety
Our guarantees for a successful study
You won't need to do it twice
Health is demanding. To avoid health’s authorithies rejection, your study needs to be up to date with all the good practices.
our norms certifications:
- ICH - GxP
- FDA (Title 21 CFR Part 11)
- Data Protection (GDPR)
- HIPAA
- Internal SOPs
- EMA
No bad surprise on the road
You won’t have to endure a sleepless night because of a poor study’s design.
our norms certifications:
- Tailored-Made Solutions or EDC systems
- Ressources optimization (with additionnal solution: Python & R)
- Double Data Quality Check (with Python & R)
- User Friendly & UX optimized
- Multi-lingual & Fully Responsive (Phone, Tablet,...)
- Flexible and able to Manage The Unexpected
- Always on time
YOUR HEALTH STUDY, EASED
No more waste of energy, time nor fund
Get safer answers thanks to flexible and highly accurate tools and services.
Each step is designed to alleviate the life of our Sponsors, their Team and Patients.
mission eased, experts fulfilled
Words From Our Sponsors
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.
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!
Travailler avec Nadia a toujours été un plaisir! Sa rigueur et son professionnalisme mènerons à bien tous vos projets en DM et en IT.
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!
