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POST-MARKETING RESEARCH HEALTH OUTCOMES RESEARCH

Science Driven Post-Marketing

In recent years post-approval studies assessing real-life effectiveness, safety, patient outcomes and health economics of marketed products have evolved from optional “nice to have” marketing initiatives to mandatory requirements.

Governments, third party payers, patients and health care providers rely on the results of post-marketing studies for
continued reimbursement support,
demonstration of effectiveness and safety.

We design and execute post-marketing studies that adhere to
rigorous principles of research that will generate evidence and answer
valid scientific questions that warrant publications.

Case Study

Essential Thrombocythaemia (rescue, orphan, registry)
The sponsor an essential thrombocythaemia study did not like the performance of their CRO (a top 5 company) and selected Pharm-Olam for a complete handover of a phase IIIb and phase IV registry in the same indication.

Patients could not have been previously treated with a cytoreductive agent and or have taken on any anti-coagulant and anti-aggregant therapies.

The phase IIIb study involved 14 countries in Western and Eastern Europe with 22 sites and 180 patients. The phase IV registry study involved 146 sites in 13 countries. 3,668 high-risk ET patients taking cytoreductive therapy were enrolled in 18 months.

The sponsor was pleased with our performance and has since awarded Pharm-Olam a third study in pediatrics.
Post-Marketing Programs
  • Observational Studies
  • Registry Studies (Patient, Disease, Drug)
  • Health Outcomes and Economics
  • Patient Reported Outcomes/Quality of Life
  • Phase IV Studies
  • Risk-Benefit and Risk Management Evaluations
  • Post-Marketing Safety Surveillance

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