Proactive planning of Phase IV activities often determines the degree of market capture for a drug. Research in Phase IV also influences the activities of the FDA with regard to post-approval commitments or safety and/or efficacy concerns with the drug. - Authority mandate
- Safety confirmation (i.e. evaluation of rare or infrequent adverse events by conducting large-scale trials)
- Expand scientific understanding leading to a competitive edge in the marketplace (i.e. comparator versus non-comparator studies, impact on subpopulations, drug interactions, etc.)
- Evaluating the drug for specialized markets such as pediatric use
- Expansion of labeling and optimization of dose
- Cost-benefit analyses and trials
- Expand the impact of your existing marketing programs
- Integrate Phase IV programs with product launch
- Conduct "real-use" programs to expand effectiveness and safety databases
- Prepare additional use and indications
- Complete authority mandated requirements
The transition from clinical development to marketplace introduction is critical to the success of any pharmaceutical, biotechnological or medical device product. We have proven expertise in the design, conduct, analysis and reporting of these post-approval programs. CCDRD will optimize your product's potential to help you gaining competitive advantage while balancing critical clinical concerns. We conduct your study in accordance with the agreement upon schedule, budget and aim to provide programs that meet the highest standards of quality from inception to completion. |
