Pakdaman Consulting offers a full suite of Serious Adverse Event (SAE) reporting services, including:

• Review of MedWatch form and/or case intake file provided by the sponsor, detailing the nature of the adverse event and including any follow-up communications with the consumer.

• Critical assessment of the medical relevance of the consumer’s complaint, accounting for any relevant medical history and concomitant medication or supplement consumption.

• Literature review of new and updated research as related to the product in question and the relationship between product consumption and the adverse event.

• Determination of the most plausible relationship between the product and the adverse event, based on synthesis of the medical history, history of product consumption, details of the adverse event, and any relevant published literature. Possible determinations include:

  • 1. None – No relationship between product consumption and the adverse event

  • 2. Unlikely – It is unlikely that there is a relationship between product consumption and the adverse event, yet certainty cannot be determined.

  • 3. Possible – There is a possible relationship between product consumption and the adverse event, yet certainty cannot be determined

  • 4. Probable – There is a probable relationship between product consumption and the adverse event, yet certainty cannot be determined

  • 5. Definite – There is a definite relationship between product consumption and the adverse event

• Write-up of a summary report detailing the professional opinion of the clinical expert, Medical Doctor (M.D.) or equivalent, as it pertains to the aforementioned details of the adverse event.

• Required materials include the MedWatch Form and details of any communications with the consumer.