All lab results are acquired from the lab and entered into the database.

Special lab specimen are tracked in a separate database and shipped to reference laboratories around the country. Shipment occurs in compliance with FAA and GCP including hazmat labels, dry ice, and insulated containers.

Every data point is entered twice by two separate data entry personnel. These double data entry points are compared against each other and any discrepancies are resolved by the data analyst.

The data analyst programs the statistical software to evaluate within-group changes, between-group differences, to determine the standard deviation, and the statistical power of these calculations.

The clinical study report is generated and tables and figures are inserted for every single endpoint. Units of measure, normal ranges, and an interpretation of the findings are provided for every endpoint. An attrition chart is provided which documents the flow of all subjects screened, enrolled, and randomized into the study. Baseline characteristics are compared between groups. Any adverse events are logged and coded according to the Medical Dictionary for Regulatory Activities (MedDRA). A final conclusion and discussion are provided. An internal QA/QC checklist with 40 different areas is checked by a senior monitor who was involved with the study.

If requested, our medical writing team will work with the sponsor to select an appropriate peer-reviewed target journal and will then produce a manuscript formatted for that journal. The manuscript will require additional literature reviews to support the discussion and conclusions required for the journal. The entire manuscript will go through several rounds of internal revisions before being sent to the sponsor for comments and questions. Another round of revisions will occur and then the manuscript will be submitted to the journal. Within 2 to 6 months, the journal editors will provide a list of peer-reviewed comments and requirements and this round of revisions will be made, additional analyses will be performed, and a detailed response document will be submitted to the journal in addition to the revised manuscript. When this final manuscript is accepted, it will be published by the journal and indexed on Medline/Pubmed.

These data, reports, and manuscripts provide the basis for our sponsors to make and defend their claims. Our data, reports, and manuscripts have been used by sponsors to successfully defend their claims with the FTC, FDA, NAD, SFDA (China), KFDA (Korea), TGA (Australia), and in litigation.