Medical Affairs Operations
Due to the interaction with the healthcare community, Medical Affairs activities highly scrutinized by government oversight agencies such as the office of Inspector General. It is important to develop compliant procedures for both in-house and filed based personnel who interact with healthcare providers. There are currently about 350 corporate integrity agreements being enforced by the OIG that include almost every major pharmaceutical company doing business in the USA. These agreements are cumbersome and resource intensive to adhere to making it important to develop compliant processes early in development of your Medical Affairs department.
At Trovare, we have experience with all aspects of Medical Affairs and we realize that one size does not fit all. Trovare can work with your team and needs to create a scalable Medical Affairs structure to suit your growing needs, or we can fulfill these activities as a full service vendor. From a compliance standpoint, Trovare can work with your team to establish SOPs and/or Work instructions that are right for the size, structure and risk tolerance of your company. Additionally, we can develop compliant processes for Medical Education, Investigator Grant support, HCP interactions and contracting for advisory boards and/or investigator meetings.