Updated capabilities overview1

Orbis Clinical Providing the world’s leading biopharmaceutical organizations with drug safety, regulatory affairs and quality assurance expertise essential in treating devastating disease.

About Orbis Clinical ,[object Object],[object Object],[object Object],[object Object],[object Object]

Inc.500 Recognition ,[object Object],[object Object],[object Object],[object Object],72 Employees $9.1 million 2008 Revenue $1.4 million 2005 Revenue 566.9% Growth 2004 Founded Health Industry 2009 Year

Services and Offerings -Project Management -Standard Operating Procedure development and review -Compliance -Process Improvement - Domestic and Rest-of-World GxP Auditing (21 CFR Part 11) Submissions : - Content development of all regulatory submissions Operations : -Indexing and Cataloguing -CTD, eCTD and SPL formatting Medical Writing : -Writing and review of all regulatory documents CMC: -Strategy, operations, and submissions Advertising, Labeling, & Promotions: -Development, guidance, and review -Risk Evaluation and Mitigation Strategies -Risk/Benefit Analysis -Risk Management Plans -Epidemiology -Pharmacoepidemiology -Health Economics and Outcomes Research -AE/SAE Case Processing -Clinical/Post-Marketing Case Review -Medical Coding -Medical Monitoring -Narrative Development -Aggregate Data Review -Signaling/Trending -Periodic Safety Update Reports -Label/PI Development,Review Epidemiology and Health and Economics Research Studies Regulatory Drug Safety Risk Management Quality Assurance

Regulatory Affairs Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Quality Assurance Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Drug Safety Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Risk Management Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Epidemiology and Outcomes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Our goal is to assist decision makers in acquiring the necessary information regarding the risks, benefits, costs, and acceptance of their products in order to make informed decisions about how to position those products in the marketplace. Orbis Clinical Consultants can assist in the following areas: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Physician Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Orbis Clinical Engagement Model ,[object Object],[object Object],[object Object],[object Object],[object Object]

Orbis Clinical Case Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Orbis Clinical Case Studies ,[object Object],[object Object],[object Object]

Orbis Clinical Case Studies ,[object Object],[object Object],[object Object],[object Object],[object Object]

Updated capabilities overview1

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Updated capabilities overview1