|
|
Periapproval Services
Services |
 |
Phase IV
Covance — The Natural Selection for Phase IV Studies
Observational (Safety/Efficacy)
Beyond traditional safety and effectiveness we excel in the design and execution of observational studies based on sound epidemiological principles. Our experts are ready to collaborate with you to chart the best course for the management of your compound in the marketplace through compelling science and solid data. We handle and extract impressive post-approval data and give you everything you need to obtain the best value for both your patients and your bottom line.
Our Phase IV observational services include:
- Pharmacovigilance; Longitudinal surveillance
- Registries (including product, disease, and pregnancy registries)
- Long-term outcome studies
- Traditional epidemiological studies
- Post-marketing regulatory commitments
- Pharmacoeconomic and outcomes research
- Time and motion studies
- Billing studies
- Burden of illness studies,
- Chart review studies
- Claims data analysis
The key benefits of these services include the ability to demonstrate product value beyond efficacy, provide additional data beyond regulatory product approval, and gain a greater understanding of the patient population.
Interventional (Safety/Efficacy)
To ensure the overall launch of your product is a success, our teams effectively manage interventional trials by following process with rigor and efficiency. We understand every cost driver and we proactively take into account every challenge to timeline and budget. We appreciate the importance of managing large volumes of data flawlessly.
Our Phase IV interventional services include:
- Studies to gauge actual use in typical patients
- Real world effectiveness, tolerability and adherence studies
- Prospective patient reported outcome and quality of life studies
- Comparator/Product Differentiation
- Novel interventional designs (including population-based designs)
- New patient populations
- Compassionate use/Early access programs
- Studies to support promotional claims
|
|
|
|
