extraordinary people, extraordinary outcomes 1 confidential september, 30 th 2014 a conversation...
TRANSCRIPT
Extraordinary People, Extraordinary Outcomes
1Confidential
September, 30th 2014
A Conversation with Edward Kaye
www.novuslife.com
2Confidentialwww.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
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.
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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.
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Why NovusLife? We need a differentiator slide.
Confidentialwww.novuslife.com
Phone:
781-790-8145
Fax:
781-996-3676
www.novuslife.com
Address:
NovusLife, LLC1344 Main StreetWaltham, MA 02451
Email: