The clinical development process is one that requires both an understanding of the science and the overlapping regulations that affect the clinical process and the collection of data from that process. We have represented our clients on the following:
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“Proof of concept” issues.
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Negotiating and drafting clinical trial agreements.
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Negotiating government contracts with National Institutes of Health (NIH) and National Cancer Institute (NCI).
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Establishing ethics committees.
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Preparing documents and interacting with Institutional Review Boards (IRBs).
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Negotiating contracts with principal investigators and each of the clinical sites, ensuring compliance with regulations both in the U.S. and the European Union (EU) on the use of human subjects in research.
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Pediatric rules and controlling risk associated with bad outcomes during the clinical trials.
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Drafting and/or reviewing informed consents.
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Electronic data management.
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Designing clinical trials in foreign countries to produce data acceptable to the U.S. Food and Drug Administration (FDA).
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Development, submission and approval of international non-proprietary names, U.S. adopted names and similar names in other countries.
Clinical Development Representative Matters
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Negotiate agreements with the principal investigators and multiple study sites.
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Represent clients in situations where adverse events have occurred including the follow on liabilities, reporting of the events and reports to the IRB.
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Represent clients in matters involving adverse events.
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Review clinical protocols and the attendant informed consent documents.
- Advise clients on conduct of clinical trials outside the United States and use of the collected data within the United States.