Pharm-Olam offers GDPR consulting services. We are adept at consulting on GDPR requirements as it relates to clinical trial implementation, regardless of whether you are based in the EU or elsewhere. We work with you to confirm that the data privacy in your trials, as well as your internal business operations, is in place and sustained.
Whether at the study or company level, our GDPR consulting service includes:
Implementation plan development
How to word the informed consent form (ICF) to be GDPR-compliant and adjust it to different country requirements
Which types of contracts are required between different parties depending on their role
Mapping data flows of all data subjects: patients, investigators, CRO and vendor employees, sponsors, etc.
Which safeguards need to be implemented for data transfers
Helping non-EU sponsors comply with GDPR obligations for EU representation, which is different than having an EU legal representative for clinical trials
Drafting information that needs to be provided to data subjects
Determining if you are required to have a DPO
Developing internal procedures for handling subject rights and managing data subject rights requests
Developing internal procedures for handling data breaches and managing reported suspected data breaches
Developing internal procedures for DPIAs and conducting DPIAs
Ensuring data protection by design is embedded in all systems and projects
Maintaining required documentation, where legally required
Staff training and on-site assistance, including updating senior management on GDPR compliance status
Managing any other relevant communication between data subjects and supervisory authorities on your behalf
Providing relevant templates
Our 2018 introductory GDPR Webinar
Right before the launch of GDPR, Pharm-Olam held a webinar introducing the concept of GDPR and how it is implemented in the clinical trial setting. You may click the video image to the left to watch this insightful webinar from 2018.
If you would also like to access the latest update on GDPR from experts, then click the button below for our latest update webinar on GDPR implementation - 1 year later.
Our 2018 introductory GDPR Webinar
If you are based outside the European Union (EU), then having an EU representative for GDPR is a legal requirement introduced by the GDPR Art. 27. (Please note that this is different than having an EU legal representative for clinical trials.) Pharm-Olam´s EU representative service fulfills all GDPR elements needed within your study, including:
Clinical Trials are large complex projects, and occasionally a sponsor may need to make a change to...
A comprehensive guide for your next rare disease clinical trial.
November 19, 2019 – November 21, 2019
Barcelona
