Define: Clinical Study

What does "Clinical Study" mean? The meaning differs based on the contract. We found 3 definitions across 3 companies in SEC filings.

Definition 1 (AMGEN INC, seen in 1 filing)

Clinical Study means a research study (including interventional and observational studies) in which data from one or more human subjects is collected to evaluate health-related biomedical outcomes, including a Phase 4 Study.

Source: AMGEN INC 10-K

Definition 2 (BIOGEN INC., seen in 1 filing)

Clinical Study means a clinical study conducted on human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed or (c) support Regulatory Approval, Pricing Approval or label expansion of such pharmaceutical product. Without limiting the foregoing, Clinical Study includes any Phase I Clinical Study, Phase II Clinical Study, Phase II Clinical Study, Phase III Clinical Study and any Phase IV Clinical Study.

Source: BIOGEN INC. 10-K

Definition 3 (ALNYLAM PHARMACEUTICALS, INC., seen in 1 filing)

Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable but excluding any Post-Approval Studies.

Source: ALNYLAM PHARMACEUTICALS, INC. 10-K

Data extracted from 3 SEC EDGAR filings across 3 companies. Source: Material contracts (Exhibit 10) filed under Regulation S-K.

This page presents definitions found in actual SEC filings for informational purposes. The specific definition appropriate for your contract may vary based on jurisdiction, industry, and specific circumstances. Consult with a qualified attorney for legal advice.

Occurrences: 3
Companies: 3
Keywords:
Clinical Studydefinitioncontract languagelegal termSEC filing

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