Personal data privacy has taken another evolutionary step with the release of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons, the General Data Protection Regulation (GDPR). If you work for an organization that is not based in the EU, you may or may not be aware of the GDPR. The GDPR, came into effect on May 25, 2018.
Pharm-Olam specializes in the conduct of complex global rare disease clinical trials. Because Phase 3 trials are designed to assess the efficacy, effectiveness, as well as safety of a new drug, this is typically a difficult, costly and time-intensive process. The difficulty of Phase 3 trials rachets up even more when it is conducted in a rare disease population.
As a thank you for subscribing, you'll receive a free copy of our GDPR Controller & Processor Checklist
Your clinical trial has been running for years potentially and now it is time to achieve a database lock that is efficient, quality driven and on time. A critical component to the overall success of any clinical trial is how Clinical Data Management (CDM) manages the trial during its conduct and how it closes it out to achieve database lock.