Medical affairs departments are struggling to maintain their strategic impact amid regulatory changes and the introduction of new industry guidelines. With the OIG guidance and the potential effects of Medicare Part D, medical affairs departments have turned to globalization, both internally and externally, to implement standards of practice across all their organizations.
CIS is primed with over 10 years experience supporting the many challenges that face medical affairs departments from a compliance perspective. We have helped develop strategic plans on the restructuring of the department, on defining the varying roles and responsibilities, and developing policies and procedures. Establishing these standards, as well as integrating them, has been a core focus for CIS in helping ensure that medical affairs are compliant with regulatory requirements.