CROs, or Contract Research Organisations, are processing personal data on behalf of the sponsors in clinical and observational studies. CROs are professional services companies that acn perform either full services, or in can be specialised in a specific part of the clinical research business: protocol design, site and patient recruitment, site start-up, monitoring, clinical data management, biostatistic, safety (vigilance), Clinical Study Reports, regulatory affaires, medical writing, reggulatory submissions, etc.
Some CROs also act as IT service company , in the sense that they can develop their own eCRF or eTMF software, provide patient apps and connected devices and all the services associated with them.
CROs are mostly Processors in the GDPR sense.
They are the go between the sponsors (= the Controllers) and the clinical sites.
But for their own internal business (like HR) , or when they do pre-screening of healthy volunteers for example, they are acting as Controllers.
At PharMarketing, we have been working for amny years with CROs of all sizes, headquartered in the EU, or in the US.
We work with data management boutique firms till full service CROs acting in several countries and continents.
We provide a monthly package tailored to the business of CROs.
Also, our local Data Protection Officer (DPO) associates in each EU country are experienced with the business of CROs.
Ask us for more information and for a quote!