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Case Studies

Harmonizing a Global Regulatory Submission Process Post-Merger

Project Background Following the merger of two major pharmaceutical companies, the newly formed (merged) organization quickly recognized that the processes for creating, managing, and archiving…

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Case Studies

Complex global alliance successfully executes clinical trials

A pharmaceutical company formed an alliance with a global CRO to plan and execute multiple phase 1/phase II clinical trials for biosimilars to support development…

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Case Studies

Reengineering of Work Processes Cuts Drug Development Timeline in Half

To be more competitive, a mid-sized pharmaceutical company needed to shorten its drug development timeline. To that end, it hired a globally recognized management consulting…

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Case Studies

Simplifying Ethics Compliance Handling Process Mitigates Drug Company’s Risk

Project Background A major pharmaceutical company embarked on an initiative to simplify, streamline, and improve the effectiveness of their internal ethics compliance processes, procedures, and…

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Case Studies

Tighter Research Processes Lead to $10 Million in New Funding for Biotech Start-Up

Project Background A start-up nanotechnology company needed to raise additional funding to continue development of its holographic optical trapping (HOT) technology. To capture investor attention,…

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Case Studies

Professional Plan and Execution Results in On-Time IND Submission and Clinical Program Initiation

Project Background A mid-size biotechnology company with multiple development candidates in their pipeline lacked an overarching strategy for moving a lead compound from selection to…

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Case Studies

Fledgling Biotech Speeds towards NDA Due to Intense Coordination Effort

Project Background A privately held, startup biopharmaceutical company had acquired a key compound for treating cancer, one of a new class of anti-cancer agents. The…

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