Clinical Operations Case Studies
Global Program Management for Rare Disease
Problem Identification
A major pharmaceutical company was in clinical trials in 80 locations around the world for a compound to treat pediatric renal failure, a rare disease state. The clinical trial was tricky and beset by major safety concerns. With no time to waste, the company needed a supervising clinical operations manager with extensive rare disease clinical trial experience. The position required a self-starter with the ability to hit the ground running.
Nature and Scope of Challenge
The pharmaceutical industry today spends far more on research and development, but produces fewer new molecules, than it did 20 years ago. That shortfall in pipeline innovation leaves drug makers unable to capitalize on the rising global demand for new medicines.
The most common impediment to research and development progress is adequate internal guidance. Archaic cultural norms can be a major roadblock to innovation and insight for complex and timely decision-making. The most successful pharmaceutical and biologics companies are nimble, constantly adjusting the way they operate; they evolve and innovate to create new therapies to meet the world’s medical needs.
Our consultants are among the top biopharmaceutical experts across a wide range of therapeutic areas. After devoting their entire professional lives to innovation in the search for medicines that prolong and improve human life, they command seasoned expertise within their fields. From pre-clinical bench science and clinical trial management to database management, medical writing and program management teams, EG Life Sciences’ consultants deliver value from the substantial investments required to develop safe and effective medicines.
Problem Resolution
EG Life Sciences quickly delivered a consultant whose decades of experience with complex and difficult human trials in rare disease states matched the drug company’s requirement. The consultant spent four years on three separate clinical trial studies, worked hand-in-hand with the drug company’s internal team, and successfully completed the final-stage clinical trial on time. The company is now preparing a submission for final Food and Drug Administration marketing approval.
Value Proposition
We help clients navigate the roadblocks of problem-solving by bringing new perspectives on productivity and streamlining operations. EG Life Sciences provides expert consultants and project teams with the precise ability to accelerate and add value to research; we thrive on helping you strategize and introduce new disease treatment options, life-saving drugs, and patient-centric, personalized therapies.