Pharmacovigilance and Safety Monitoring

Frontage Pharmacovigilance and Medical Safety Monitoring assists clients in analyzing postmarting safety data to assess product risk profile and help you make informed decisions about risk minimization.

 

With thorough monitoring and expedient delivery of reports, we can alert you to safety issues that may signal excess adverse events for your product.

 

Following FDA Good Pharmacovigilance Practices, Frontage delivers case reports that can include any or all of the following:

 

1. Description of the adverse events or disease experience, including time to onset of signs or symptoms;

 

2. Suspected and concomitant product therapy details (i.e., dose, lot number, schedule, dates, duration), including over-the-counter medications, dietary supplements, and recently discontinued medications;

 

3. Patient characteristics, including demographic information (e.g., age, race, sex), baseline medical condition prior to product therapy, co-morbid conditions, use of concomitant medications, relevant family history of disease, and presence of other risk factors;

 

4. Documentation of the diagnosis of the events, including methods used to make the diagnosis;

 

5. Clinical course of the event and patient outcomes (e.g., hospitalization or death);

 

6. Relevant therapeutic measures and laboratory data at baseline, during therapy, and subsequent to therapy, including blood levels, as appropriate;

 

7. Information about response to dechallenge and rechallenge; and

 

8. Any other relevant information (e.g., other details relating to the event or information on benefits received by the patient, if important to the assessment of the event).

 

Though compliance with applicable postmarketing requirements is sufficient in most cases, there are some products that may present unusual safety risks before approval or after marketing.  In these cases, Frontage can assist in developing a long term pharmacovigilance plan.

 

This plan would descrbe efforts above and beyond routine postmarketing spontaneous reporting, and is designed to enhance and expedite your acquisition of safety information.