GUIDANCE & SURVEILLANCE PROGRAMS
Catch the Snowball Before it Becomes an Avalanche
 For some products, Education & Outreach is only the first phase in managing risk. Toxicology tests or clinical trials may indicate the potential for rare effects due to existing conditions, concomitant medications or long-term use. It may be imperative to know if your new product is being taken as prescribed; or if physicians are heeding the warnings in the latest Dear Health Care Professional letter; or what the numerator and denominator are for certain adverse events or events of interest reported.
Sentrx Guidance & Surveillance programs provide the infrastructure to proactively gather information on how your product is being used and tolerated in patients in a real-world setting. OnTrak™ Controller allows physicians, patients and/or pharmacists to register for your safety program on the Web or by telephone. From there, Guidance & Surveillance may include:
- Outbound calls to physicians and pharmacists to confirm receipt of a Dear Health Care Professional letter and to ensure understanding of risks and appropriate prescribing conditions
- Interviews with patients to determine their understanding of proper use and to solicit adverse events proactively
- Certification program to train practitioners on contraindicated conditions and monitoring for adverse events
If medical interviews or surveys are part of your risk management protocol, OnTrak™ Controller allows participants to select the most convenient date and time to be contacted by our Safety Monitors. This accommodation increases the rate of successful survey completion and allows sponsors to collect data within a certain therapy window. SurveyTrak™ Interviewer, with its browser-based interface, drop-down menus and nested questions, ensures that consistent and accurate information is collected. Ultra-secure Web access to authorized entities allows results to be monitored in real-time. |
