A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more
1/17/2020
/ Best Practices ,
Big Data ,
Clinical Trials ,
Data Collection ,
Data Management ,
Data Processing Rules ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
Information Management ,
Information Technology ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Patient Privacy Rights ,
Personal Data ,
Pharmaceutical Industry ,
R&D ,
Research and Development
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more
4/25/2019
/ Clinical Trials ,
Data Collection ,
Data Processors ,
Data Protection ,
Electronic Medical Records ,
EU ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
Informed Consent ,
Personal Data ,
Pharmaceutical Industry ,
Regulatory Standards ,
Scientific Research
Blockchain and artificial intelligence (AI) are opening new doors towards improving data efficiency in the life sciences industry. But these technologies may also impose unique limitations and curtail the traditional role of...more
10/24/2018
/ Artificial Intelligence ,
Blockchain ,
Clinical Trials ,
Data Controller ,
Data Management ,
Data Privacy ,
Distributed Ledger Technology (DLT) ,
General Data Protection Regulation (GDPR) ,
Information Technology ,
Internal Data Controls ,
Life Sciences ,
Personal Data ,
Pharmaceutical Industry ,
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