Why RD Privacy?
RD PRIVACY was created to support pharmaceutical companies to ensure compliance with the GDPR and applicable privacy laws, when conducting clinical trials in EU countries.
Why?
Because after spending more than a decade in advising life science industries on GDPR compliance, I understand the challenges of the start-up phase of a clinical trial; I know the timings and the urgencies, and I can plan a compliant privacy strategy that aligns with clinical trial goals.
Over the years, I have advised CRO’s and pharmaceuticals on how to address GDPR requirements, on understanding the issues that may be raised during the conduct of a clinical trial and I’ve worked with multiple clinical teams to support them in gaining awareness on privacy requirements and on how these interact with their daily work.
From feasibility to regulatory affairs, passing through site contracts and project management teams, I have supported them all, and I love doing it.
Every clinical trial is unique, and although the initial steps are very similar in all research studies, there are specific details that make the difference, and if not spotted in time, may potentially result in GDPR violations. Also, individuals involved in the research studies have different levels of privacy maturity, so we may end-up talking more about privacy and its impacts with a certain clinical trial team versus another, due to the different levels of experience and understanding of privacy standard requirements.
Concepts such as pseudonymized data and anonymized data still confuse a lot of those working in clinical trials, so it’s always good to refrain that even though patient’s data is key-coded, that’s still personal data that needs protection under the regulation.
In addition, country laws may difficult privacy compliance as there’s not a unique legal framework for all EU countries, but every country has its own GDPR implementation law, which in addition to GDPR requirements impose some other, country-specific that must be taken into account when working on ensuring privacy compliance for global clinical trials.
And because scientific research is a regulated industry, we can never forget about the interaction between clinical trial’s regulation and privacy. On many occasions, requirements for data integrity and safety will validate privacy controls, so measures to safekeep trial data and personal data may coincide.
Privacy compliance is a continuous work…so even though you comply with implementing requirements of a project, as imposed by the GDPR, monitoring compliance during the entire lifecycle of the processing of persona data is key to ensure you are on the right path.
I’ve decided to create RD Privacy because I’ve identified the need for a good quality privacy support in the area of scientific research; I knew that I could be of service, and it was with that strong feeling of purpose that I moved forward with my idea. My project management skills allied with my deep knowledge on how to ensure privacy compliance in clinical trials, gave me the strengths to do it, because I could understand the importance of such support.
It’s not about one trial or one client, it’s about supporting scientific research to help improve the life of human beings. By supporting pharmaceuticals in conducing privacy compliant clinical trials, I’m not only reducing their risk of being fined by data protection authorities, which results in economic losses and reputational damage, but I’m helping people in general to trust scientific research, from patients, to research partners, to general population.
As I usually say, being compliant is not a “nice to have” but it’s a “must be”, as it’s not something you can get, but something you continuously need to work on; and it’s mandatory if you want to serve your purpose and grow genuinely.
Privacy, in the area of scientific research, is as important as any regulatory requirement, in fact it is dictated by clinical trials regulations, so if you’re asking yourself whether you have to comply with privacy laws in the scope of clinical trials, the answer is a big YES.
RD Privacy is here to offer a service of excellency, to support sponsors in achieving clinical trial goals, while respecting privacy requirements, so if you are looking for the right partner to support you in conducting privacy compliant clinical trials, do not hesitate in contacting us.
Our diligence, responsibility and sense of purpose is what guides us in offering the best service and we will be trilled to hear from you and helping you moving one step forward into your goals.
x Diana
