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Phase IV and Post-Marketing Strategies for Evidence of Efficacy

Showing the Outcome of a Healthier World

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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.  

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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:

  • Observational studies
  • Registry studies (patient, disease, drug)
  • Phase IV studies
  • Retrospective data collection
  • Effectiveness comparatives
  • REMS/safety outcomes
  • Post-marketing safety surveillance

 

Pharm-Olam Pharm-Olam
Pharm-Olam Pharm-Olam

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:

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Oncology-Hematology Center of Excellence

Our dedicated team of cancer researchers creates solutions and provides consultations focused on the needs of your sites and patients — all while helping to save your study time and money.

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Infectious Disease and Vaccines Center of Excellence

Our infectious disease and vaccine site networks are dedicated to supporting this critical area of research in every area from immunizations to immunotherapy.

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Rare Disease Center of Excellence

With more than 100 rare disease clinical trials completed, we provide the expertise and experience to meet the unique challenges of these studies.

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General Medicine

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.

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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.

 

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Pharm-Olam Pharm-Olam

Pattern of Excellence

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.

Why Pharm-Olam

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Sponsor Testimonial

The Pharm-Olam team was very professional, supportive of our requirements, showed flexibility when necessary for the project and have been a real pleasure to work with.

Small Pharma - Clinical Project Manager

vaccine

Ready to find out how our experts can create a unique strategy for your late phase or post marketing needs?

Talk with our team today.

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