Innovative Analytics supports exploratory studies and clinical drug/device development programs with standard and innovative data management, statistical, and medical writing services. We have considerable experience with the clinical validation of imaging, genomic, and biochemical biomarkers.

Our database and analysis processes are ICH and GCP compliant. We have extensive experience with the content of and eCTD formats for US, EU, and Japanese regulatory submissions for various therapeutic areas and orphan drugs. These include INDs and NDAs for drug applications, as well as PMAs and 510(k)s for device applications.

We provide large and small clients with flexible “turn-key” support, resource augmentation, and consulting arrangements.

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