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?
One of the major innovations in clinical research is e-health. New medical devices are emerging such as wearable devices:
Fitbits, Apple watch, smartphone applications are accelerating data collection while increasing patient participation and engagement.
These tools should increase efficiency by extending lead times and reducing costs. This prevents patients from not attending their monitoring visits
or dropping out in the middle of a clinical trial.
According to Pharmaceuticals Research and Manufacturer, 94% of pharmaceutical companies and CROs plan to use Mobile Health.
Risk-based monitoring refers to a series of monitoring processes that include the presumed risks that could affect the quality or safety of a study,
advised by Health Authorities (ICH GCP Guideline E6[R2]) for responding better to trials’ main challenges and priorities.
Today, only 5% of side effects concerning drugs and other health products are reported to health authorities.
This is why one of the major challenges of pharmacovigilance is to involve patients more strongly in the pharmacovigilance process because the signals are very weak and therefore underestimated.
A solution? Search for pharmacovigilance cases on social media by Social Monitoring.
Wearable devices represent a big innovation not only in our daily routine, but also in the research field.
With the complexity and growth of number of clinical trials registered worldwide, technology and devices seem to respond
to the data collection current issues: gain of time, simplification of procedures and regulatory compliance.
Innovation in chemotherapy provides both healthcare and software professionals with new challenges and opportunities in providing the best possible care.
In particular, the trend towards home-based chemotherapy changes the nature of the day-to-day relationship between patient and hospital.
In the past, clinical trials have used only structured, clinically-sourced data, which was relatively easy to organize and mine.
But, today to analyze large amount of data quickly, things have changed.
By 2020 the total amount of data stored is supposed to be 50 times larger than today.
One of Pharmacovigilance's biggest problems is that very often patients do not declare their adverse drug reactions (ADR).
According to an EMA study, patients don't report their ADR because they don't know they can or should. 96% of ADR are actually unreported.
Are social networks the missing link?
We collected recommendations and ideas from several interested healthcare professionals and potential partners anywhere in the world
in relation to our application "Chemo at Home" topic to launch the best possible e-health application in the follow-up of cancer patients treated orally.
We interviewed some oncologists from different hospitals, clinics and private practices in Strasbourg,
who gave us their opinion and recommendations about the application.
Inception of harmonised regulatory requirements revealed an important step toward high responsibility for human health safety.
The process of regulatory harmonisation goes along with constant simultaneous developing of safe solutions for routine activities.
Even though, there is still an empirical collection of various experiences, without sharing of best practices would be the current progress not possible.
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?
In the past, clinical trials have used only structured, clinically-sourced data, which was relatively easy to organize and mine.
But, today to analyze large amount of data quickly, things have changed.
By 2020 the total amount of data stored is supposed to be 50 times larger than today.
Today, only 5% of side effects concerning drugs and other health products are reported to health authorities.
This is why one of the major challenges of pharmacovigilance is to involve patients more strongly in the pharmacovigilance process because the signals are very weak and therefore underestimated.
A solution? Search for pharmacovigilance cases on social media by Social Monitoring.
Wearable devices represent a big innovation not only in our daily routine, but also in the research field.
With the complexity and growth of number of clinical trials registered worldwide, technology and devices seem to respond
to the data collection current issues: gain of time, simplification of procedures and regulatory compliance.
Risk-based monitoring refers to a series of monitoring processes that include the presumed risks that could affect the quality or safety of a study,
advised by Health Authorities (ICH GCP Guideline E6[R2]) for responding better to trials’ main challenges and priorities.
One of the major innovations in clinical research is e-health. New medical devices are emerging such as wearable devices:
Fitbits, Apple watch, smartphone applications are accelerating data collection while increasing patient participation and engagement.
These tools should increase efficiency by extending lead times and reducing costs. This prevents patients from not attending their monitoring visits
or dropping out in the middle of a clinical trial.
According to Pharmaceuticals Research and Manufacturer, 94% of pharmaceutical companies and CROs plan to use Mobile Health.
One of Pharmacovigilance's biggest problems is that very often patients do not declare their adverse drug reactions (ADR).
According to an EMA study, patients don't report their ADR because they don't know they can or should. 96% of ADR are actually unreported.
Are social networks the missing link?
We collected recommendations and ideas from several interested healthcare professionals and potential partners anywhere in the world
in relation to our application "Chemo at Home" topic to launch the best possible e-health application in the follow-up of cancer patients treated orally.
We interviewed some oncologists from different hospitals, clinics and private practices in Strasbourg,
who gave us their opinion and recommendations about the application.
Inception of harmonised regulatory requirements revealed an important step toward high responsibility for human health safety.
The process of regulatory harmonisation goes along with constant simultaneous developing of safe solutions for routine activities.
Even though, there is still an empirical collection of various experiences, without sharing of best practices would be the current progress not possible.
Innovation in chemotherapy provides both healthcare and software professionals with new challenges and opportunities in providing the best possible care.
In particular, the trend towards home-based chemotherapy changes the nature of the day-to-day relationship between patient and hospital.
What should you do or avoid doing to make a study user friendly for the sites and data managers?
Tips regarding layouts, edit checks and other options that can affect how easy or confusing RDC is to the end users
Procedures for flexible studies
Using procedures in the context of flexible studies, e.g. define DCI and Interval rules, assign DCI Books to patients
Flexible studies for Oncology (Multiple Cycles)
Features in OC 4.6 that allow you to build flexible studies, but focus on the problems encountered in oncology studies specifically: managing multiple cycles, the number of AEs, labs collection (usually local labs), unexpected pages, ...
Optimize procedures setup for RDC
For RDC studies, procedures must be setup on a more precise way, and must also be created faster when compared to paper studies.
The purpose of the presentation is to propose a few ideas to accelerate the procedures setup process.
The Use of AI in Pharmacovigilance 
mHealth 
Risk Based Monitoring 
Pharmacovigilance and social media 
Wearable devices in clinical research 
E-Health 
Bigdata in clinical data management 
The use of Social Media in PV 
E-Health App for cancer patients 
PV within technic solutions 