Increasing pressure on DPO

We are seeing everyday new regulations popping up. Those regulations are most of the time a good framework to regulate the different interests especially in the society. In our daily business across clinical trials we encounter more and more DPOs that are challenged to comply with those regulation and at the same time continue to operate the business in adequate economic performance.

We have encountered especially in the payments of patient several challenges in Europe that we can present here

  1. ANONYMOUS REIMBURSEMENT (GCP, DIR 2001/20/EC & Reg 536/2014)
  2. PERSONAL DATA PROTECTION (Dir 95/46 CE & Reg 679/2016)
  3. APPROVED e-PAYMENT FOR THIRD PARTIES(Dir 2015/2366 & 2009/110)
  4. ANTI-MONEY LAUNDERING & TERRORIST FINANCING (Dir 849/2015 & Reg 847/2015)
  5. ARCHIVING & TRACEABILITY (IFRS)

you would need to be very creative and innovative to make sure you can comply as CROs or Sponsors to those regulations. If you are interested into getting to know more, please contact us.