The BROD GROUP has provided state of the art Health Outcomes and Late Phase strategy and design services to the pharmaceutical and biotech industry for clients such as Lilly, Novo Nordisk, Novartis, and Organon. These services include:
- Health Outcomes Strategy Plans: Including a Health Outcomes strategy early in the drug development process (Phase II) provides critical information needed to address concerns of regulatory agencies and at the same time addresses the multiple audiences who can make or break the commercial effort to position a product. Inclusion of Health Outcomes is a minimal investment with the potential for maximal return and allows for proactive planning for maximizing product positioning at launch. The BROD GROUP can develop a Health Outcomes Strategy plan for your drug which will provide the blueprint for an optimal Health Outcomes research and dissemination plan throughout the drug development process.
- The Development and Validation of Patient Reported Outcomes (PRO's): Patient Reported Measure are increasing a vital part of FDA submissions for new drugs. The BROD GROUP can assist with the development, validation and coordination with the FDA for these measures including Quality of Life, Patient Satisfaction, Work/Life Productivity and Functioning.
- The Design of Health Outcomes Studies Throughout the Drug Development Life Cycle: Health Outcomes studies can be critical for ensuring FDA approval, positioning products at launch and maximizing commercialization objectives over the entire life cycle of a drug. The BROD GROUP can design studies with Health Outcomes as primary outcome or piggyback Health Outcomes studies for clinical trials in Phase ll through Phase IV.
- Late Phase Research Strategy Plans: Phase lll is the optimal time to begin addressing Late Phase research objectives that will bridge clinical and marketing needs to optimally position products in the market. The Brod Group can help you to optimally position your drug during peri and post launch to meet commercialization objectives while maintaining scientific integrity by proactively planning a Late Phase Strategy which addresses the specific audiences, objectives and regulatory requirements for your drug.
- Late Phase Design: Late Phase studies are crucial to understand the effectiveness of a drug in the "real world" of clinical practice. These studies include Registries, Comparator Trials and Effectiveness Trials. The BROD GROUP is expert in designing these types of studies which further our understanding of a drug while addressing both clinical and marketing objectives for real world data for multiple audiences including payor, patients, clinicians and regulatory agencies.
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