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Diversity in Clinical Trial Participation

Medical products are safer and more effective for everyone when clinical research includes diverse populations. Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race...

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Informed Consent for Clinical Trials

To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent...

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