Phase IV and Post-Marketing Strategies for Evidence of Efficacy
Showing the Outcome of a Healthier World
Although the approval of your study drug to market is a huge milestone, more research is needed to know exactly how your product performs in real-world settings. We design and execute late phase and post-marketing studies that adhere to rigorous principles of research that will generate evidence, answer valid scientific questions and provide data suitable for publication.
As your experienced strategic partner, we support your research objectives by helping to monitor safety, demonstrate effectiveness, evaluate benefit-risk and prove efficacy. By providing customized strategic and scientific solutions, Pharm-Olam can support your study needs to further bolster the data you have available to drive your product commercialization activities, in a cost-effective and seamless manner. We help to generate the data you need to meet your post-marketing requirements.
Full-service Late Phase Capability
Full-Service Capabilities That Bring Real-World Results
Because of our late phase and post-marketing expertise, we have the capabilities and services needed to fully support your needs. We provide the following late phase and post-marketing services:
Registry studies (patient, disease, drug)
Phase IV studies
Retrospective data collection
Post-marketing safety surveillance
Therapeutic areas of focus
Therapeutic Expertise Brought to You by Our Centers of Excellence
Our therapeutic Centers of Excellence (COEs) support your late phase and post-marketing study by providing ecosystems of therapeutically aligned, cross-functional teams. These teams of experts help to enhance and underscore our capabilities and service offerings by creating synergies and efficiencies that help your study reach its goals and milestones. Our COEs cover the following specialty research areas:
In addition to our CoEs, we provide diverse therapeutic expertise in areas such as allergy-respiratory, gastroenterology, neurology-pain, and rheumatology and inflammation to ensure all the moving parts of your study function seamlessly.
Post-Marketing Pharmacovigilance & Medical Information
Deep Expertise in Post-Marketing Safety Surveillance
Our U.S.-based team has worked for more than 30 years within the post-marketing and medical information area. Our impeccable record of service includes multiple successful FDA audits with zero findings in support of post-marketing and medical information activities.
Some of our services include:
Product inquiry response and management
Product complaint intake and management
Adverse event intake
Medical information response letters
For a full-list of our services in support of your post-marketing safety requirements, please see our Pharmacovigilance and Medical Information page.
Demonstrated Accountability Through Our Pattern of Excellence
Our passion for providing the best service possible extends to our post-marketing and late phase studies. Adhering to our Pattern of Excellence means we hold ourselves accountable for the success of every aspect of your study. Making this goal our highest mission each day ensures we are doing everything we can to help you create a healthier world.
To learn more about our Pattern of Excellence, visit our Why Pharm-Olam page.