To support clinical development programs, PMI established HSAC.
In response to our clients’ increasingly sophisticated clinical development programs, PMI established the Healthcare Services Alliance Committee (HSAC). HSAC is a global organization of consultants and companies that provide complementary industry services to address the medical product lifecycle from development through commercialization. Through HSAC, our clients benefit from the exceptional expertise of locally-based and/or niche service providers while continuing with PMI as their program leader. Such arrangements often increase both program efficiencies and quality, which adds significant value to our clients.
HSAC members are bound by their commitment to quality and a single code of ethics. We work together to share relevant non-competitive business trends and information, increase the scope of new business opportunities, and expand resources to benefit our clients.
HSAC Network Services
- Regulatory strategy consultation: Helping clients understand and manage regulatory procedures and requirements to facilitate achievement of product approval objectives
- Pre-clinical testing: Providing in vivo studies as well as analytical chemistry and microbiology support for toxicology and metabolism studies
- Primary and secondary market research: Providing accurate and timely information regarding targeted medical specialties or therapies
- Study feasibility assessments: Understanding the issues that may affect study performance, such as appropriate study sites, patient recruitment, and more
- Regulatory submissions: IDE, IND, 510(k), PMA, NDA, country-specific (non-U.S.) product approval dossiers
- Early phase/safety studies
- Product registration studies
- Quality system implementation: Understanding and implementing methods and controls for product design, manufacture, packaging and labeling
- Economic strategy and reimbursement: Consulting in the area of Medicare/private pay insurance reimbursement as well value-based technology and strategic market positioning