Commercial Compliance

In life sciences, compliance is owning many internal and external processes, hence why it is such an important topic. We believe that user experience for the life sciences employees is key when it comes to managing their interactions with HCPs while remaining compliant. Whether it is the reporting of a dinner with an HCP during an event or the implementation of a new tool to manage grants & donations, there is an opportunity to rethink the overall employee experience. We strongly believe that both processes and systems must work in harmony to provide an uninterrupted flow of data to the compliance teams who can therefore ensure all aspects of the regulations are respected. 

 

Our team can advise companies on the best approach to manage the engagement with HCPs and HCOs. As regulations are constantly evolving, the industry is facing new cases and innovative engagement model. As such, setting up an organization and processes able to keep up with this adaptative framework becomes critical. Our experts will ensure the data required to update the setup is flowing through the various system of engagement and can advise on setting up risk-based approaches to improve efficiency and automation. 

 

When it comes to the actual management of the engagement with HCPs, a system is the core of the harmonized process. Our consultants have become expert in implementing such tools. Whether it’s IQVIA HCP/O Engagement, MediSpend HCP engagement or others, our accelerators can fast-track the implementation through process setup, data alignment and best practices training. 

While the EPFIA guidelines are relatively loose, multiple Countries in Europe as well as the US have implemented laws to enforce life science organizations to disclose of the transfer of values made to HCPs. Additionally, HCPs may need to provide their consent for a detailed transfer of values disclosure. Our team of transparency reporting experts are supporting life science organizations setup both processes and operations to disclose the data appropriately. 

 

The team is used to implement tool to facilitate the reporting to the local authorities whether it is in France, Denmark, Spain, or any other Countries with a statutory disclosure. Although transparency reporting is a compliance and legal requirement, it is also an opportunity to gather an insight into the types of transfer of values for an organization, how does an organization compare with its peers regarding transfer of values, consent to disclose and much more. Our experts can help you gather requirements, design, and implement the transparency analytics you need. 

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