Data Management

We are specialized in Data Management activities and propose a wide range of services to help you to improve the performance of your team and the quality of your data

EDC selection

Thanks to our strategic partnerships with software vendors and our expertise, we help you select the EDC application that meets the best your needs, depending on:

The complexity of your studies
The therapeutic area
The ease of integration within your Data Management activities
The reusability of your standard forms
...

We may also test your selected application with a pilot using your standards

Implementation & Configuration

Do you need help or support to install or configure your EDC software in-house or in the cloud?

Software installation
System configuration
Setup of Medical Coding Dictionaries
Definition of User access and privileges

Computer System Validation

How are you validating the new versions of your hosted EDC when you are busy with a database lock?

We can help you!

Produce validation documents
Run test cases
Provide recommendations on your validation effort

Training

We train your staff and site users on various Clinical Data Management topics, either via our eLearning tool or with online and on-site trainings

Trainings may be customized to match your team’s needs based on the experience and expectations of the trainees

We also develop training material and e-learning modules for your Data Management software and processes

Are you interested in getting more details about our training modules?
Would you like to discover our eLearning platform?

Click here for more details about our trainings

Data migration

When dealing with various data sources or switching to a new software or environment, you may need to migrate data

How are you building SDTM datasets?
Do you need to upload external data into your EDC system?
Are you satisfied with your data extraction?
Are the AEs collected during your trials automatically imported into your PV System?
How many different applications are sharing the same data?

We transform and migrate the data for you to your new server, new application or new database by making the appropriate data cleaning and validation

Process Optimization

Clinical Data Management activities are constantly changing and new tasks must be performed

Adding new resource or increase delays is not the best alternative, sometimes it is needed to just simply reinvent the way we work

Imagine new methods of work to improve quality and save time
Implement CDISC or your own standards
Create or improve SOPs
Adapt your processes to new software
Risk-Based Monitoring implementation
Use your EDC on the most efficient way

Study Build

Are you running out of time to build your study before First Patient First Visit?
Do you need to implement changes in your study before the next interim analysis?

We propose Study Build services:

Database creation
Edit Checks programming
Management of post-production changes
Build of Library standard forms
Implementation of CDASH forms

EDC vendors

We are partner with several EDC vendors:

Oracle
Medrio

But also support other applications:

Viedoc
Formedix
Medidata Rave
ClinCapture
Ennov
Datatrak
...

Data analysis & statistics

Do you need a SAS, R, SQL, or Python expert?

We produce data reports, data evaluations and statistical analysis of your clinical trial data:

Data reports - data listings or graphical reports
Patient profiles
Statistics

Including Artificial Intelligence, Machine Learning & Big Data processing

Support

Our team of experts is available to support your staff and site users when dealing with software issues

We may be contacted for any issue or question using either dedicated local phone numbers in various countries or via our web application

IT/QA Audit

We ensure you IT Systems processes are robust by performing an audit:

System maintenance
Software development life cycle
Access to data
Security
Business continuity
Office setup
Back-up
Disaster Recovery plans
...

Software development

We are specialized in various databases (Oracle, MySQL), programming languages (PHP, SAS, Python, ...) and IT systems, and can develop custom applications or mobile app for you

How are you managing post production changes in your clinical trials?
How are you ensuring compliance of your data and metadata with your standards?

Do you want have a look at our publications?

Click here to read