Pharmacovigilance

Process Optimization

Pharmacovigilance tasks require always more time, as the number of reported events is increasing

We may help you to define and implement the most efficient methods to reach your objectives

Imagine new methods of work to improve quality and save time
Automate case classification using AI
Create or improve SOPs
Adapt your processes to new software
Identify new ADR in Social Media or from phone calls given to your customer support line
...

The Use of AI in Pharmacovigilance

Pharmacovigilance has to deal with an increasing volume of data.
Artificial intelligence is able to manage huge amounts of data generated by our digital world.
Is there a way to merge these two worlds?
Let's discuss the opportunities that AI brings to PV data, and also be aware of the challenges associated with implementing this technology.
We need to answer the following key question: "Is it really safe to transfer the responsibility for pharmacovigilance to software that claims to be able to think, even though we all suffer from software errors and cyber attacks?

Click here get the text version...

Computer System Validation

We validate or evaluate your Drug Safety applications or new releases

Production of validation documents
Execution of test cases
Support during your validation

Training

We provide Drug Safety and PV systems trainings, either via our e-Learning 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 Pharmacovigilance software or your internal processes

Are you interested in getting more details about our training modules?
Would you like to test our e-Learning solution?

Click here for more details about our trainings

Data migration

You might be receiving cases from different sources and we know how resource and time consuming it can be to integrate all your data into one single database

Do you need to migrate your PV-data into a new database or to the Cloud?
Do you collect cases in several different databases and need to reconciliate all data into your central database?
Do you get Excel spreadsheets containing PV cases?
Are the AEs collected during your trials automatically imported into your PV System?
How are you performing Signal Detection?

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

Do you know that Artificial Intelligence may be used to

Process calls and transform them into concrete data points so that call data may be recorded in the PV database
Classify automatically cases received from any source so that you only need to review the work done
Get new cases from Social Media and upload them into your Drug Safety database

Data analysis & statistics

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

We produce data reports, data evaluations and statistical analysis of your Drug Safety data:

Data reports - data listings or graphical reports
Data Evaluations for PSURs
Signal Detection
Statistics

Including Artificial Intelligence, Machine Learning & Big Data processing

Software selection

Is your current PV system still matching your needs?
Are you able to easily collect, report and analyze your cases?
Are you thinking about switching to a Cloud application?

Thanks to our partnerships with different software vendors, we can help you select application that meets the best your needs for Case Processing and Signal Management

Implementation & Configuration

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

We may install and setup the software for you or guide your team through it

Software installation
System configuration
Cloud Migration

Application Support & Technical assistance

We provide application support for Drug Safety systems, and help resolving functional and technical issues

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

PV Software Vendors

We are partner with the following vendors:

Oracle (Argus & Empirica)
Martifarm (Sympto)

But also support other applications:

SafetyEasy (AB Cube)
ARISg

Process Optimization

Pharmacovigilance tasks require always more time, as the number of reported events is increasing

We may help you to define and implement the most efficient methods to reach your objectives

Imagine new methods of work to improve quality and save time
Automate case classification using AI
Create or improve SOPs
Adapt your processes to new software
Identify new ADR in Social Media or from phone calls given to your customer support line
...

The Use of AI in Pharmacovigilance

Click here get the text version...

Computer System Validation

We validate or evaluate your Drug Safety applications or new releases

Production of validation documents
Execution of test cases
Support during your validation

Training

We provide Drug Safety and PV systems trainings, either via our e-Learning 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 Pharmacovigilance software or your internal processes

Are you interested in getting more details about our training modules?
Would you like to test our e-Learning solution?

Click here for more details about our trainings

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

Are your PV applications providing all features you need?
Does your PV application allow you to be 100% compliant with the regulations?

If not, we may create custom software for you to ensure your PV System matches your expectations

We are specialized in various databases (Oracle, MySQL) and programming languages (PHP, SAS, Python, ...)

Animal Health

We also have a significant experience in providing these services in the Animal Health area

Click here to learn more