Compliance

February 21, 2020

 

 

In one of the most regulated industries in the world, it is essential for CROs and sponsors to have confidence that your meeting planning and patient services provider has a complete understanding of industry compliance regulations, as they evolve and change over time. For this purpose, Paragon reviews and understands these guidelines long before your pharmaceutical meeting is sourced in its host-country. Our team will assist in examining areas such as physician spend, gifts, and property/food/beverage spending. As a result, we can effectively guide your project managers in planning for transfer of value items and physician payment protocol as well as inform decision makers of compliance/ICH-GCP guidelines.

Our experience in patient travel support has informed our processes, with a focus on confidentiality and improving the overall patient experience. Similarly, we support your efforts for good clinical practice by working with study coordinators to provide participants with quick and accurate reimbursement services. Paragon Global is fully compliant with Physician Payment Sunshine Act as well as General Data Protection Reporting (GDPR, Europe) requirements.

 

EXPERIENCE

We are proud of our 25 years of service to CROs, worldwide and are highly experienced with the following codes and regulatory standards:

Pharmaceutical Research and Manufacturers of America (PhRMA)

Sunshine Act Reporting

Association of British Pharmaceutical Industry (ABPI)

Advanced Medical Technology Association (AdvaMed)

European Pharmaceutical Market Research Association (EphMRA)

Prescription Medicines Code of Practice Authority (PMCPA)

European Federation of Pharmaceutical Industries and Associations (FPIA)

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