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Extraordinary People, Extraordinary Outcomes 1 Confidential September, 30 th 2014 A Conversation with Edward Kaye www.novuslife.com.

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Presentation on theme: "Extraordinary People, Extraordinary Outcomes 1 Confidential September, 30 th 2014 A Conversation with Edward Kaye www.novuslife.com."— Presentation transcript:

1 Extraordinary People, Extraordinary Outcomes 1 Confidential September, 30 th 2014 A Conversation with Edward Kaye www.novuslife.com

2 2 Confidential www.novuslife.com Supporting Studies: HEOR, etc. Regulatory Approval Pre IND Phase Phase I – II Clinical Trials Phase III – IIIb Clinical Trials Pharmacovigilance / Post- Marketing Commitments / Phase IV Clinical Trials / Registry Pharmacovigilance / Post- Marketing Commitments / Phase IV Clinical Trials / Registry NovusLife, among other services, is helping companies compile the required clinical evidence from the very beginning of their clinical development programs. We believe that this is crucial for firms such as Sarepta.

3 3 Why NovusLife? The consultants at NovusLife can help you design and implement the strategies and programs to build the clinical evidence required to support the development and launch of your drug (or device) product. Benefits to clients: We are part of your team. You keep full control over your projects, meet your timeline and budget milestones, and achieve your corporate goals. We help you create an efficient roadmap toward the approval, launch, and optimal uptake of your new product. Engage the appropriate stakeholders early and often to identify and gather the most important clinical evidence. Set the guardrails within which your research vendors (e.g. CROs, EDC, etc.) operate. Anticipate emerging issues and possible detours along the clinical development path and apply the right solutions. We can lead clinical development projects from inception through completion – or support specific steps in-between based on your requirements. Ensure continuity of goals and action plans among your vendors and stakeholders along the research path. Avoid the pitfalls of missed opportunities.

4 4 Why NovusLife? We need a differentiator slide. Confidential www.novuslife.com

5 Phone: 781-790-8145 Fax: 781-996-3676 www.novuslife.com Address: NovusLife, LLC 1344 Main Street Waltham, MA 02451 Email: Info@novuslife.com accounting@novuslife.com careers@novuslife.com


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