Safety and Risk Management

Safety Consulting

Good drug safety does not happen by accident

Significant demands are placed on PV systems in order to deliver effective products for which we understand the patient safety.  All drugs have risks, but in order to be effective, the efficacy of the drug must outweigh the risks.  Thus, the understanding of the Benefit:/Risk ratio necessitates a broad knowledge of the drug’s safety profile.  This is a continual process as drug safety must be understood today, tomorrow and in the future.  Presently the complexity of understanding a drug’s safety profile is ever increasing and this adds to the demands of a PV system.  Examples of the ever changing PV environment can be seen by new regulations, more complex drug pharmacology, multiple and varied data sources, differences in medical practice globally, new software, education required to properly use drugs, risk management programs, and the large amount of medications now used to treat disease states.

The good news is that with a planned and organized PV system, drug safety can be well understood in an ongoing manner.  The drug can be used in the correct way, for the right patients, and the drug safety monitored to assure the benefits always outweigh the risks for the patients using the drug.   This brings us to the central point, good drug safety or PV does not happen by accident and good PV will support strong life cycle management.  The correct organization, talent, tools, and resources must be in place for this to work.  With Sciformix Safety Consulting, we can provide the knowledge and expertise to ensure that your PV system can effectively monitor the safety profile of your products or to transform your present PV system into a highly organized and effective PV function.

Our Capabilities and Services:

• Sciformix has an internal consulting team of experts in safety and risk management and PV operations who are supported by statisticians, data managers, clinical research professionals and process consultants who are able to consult for PV and translate their knowledge and expertise into winning strategies and best practices for our clients
• Examples of consulting services include: PV organizational design, PV planning, PV governance, design of risk management activities including RMPs and REMS, PV systems gap analysis, PV regulatory interaction, PV audits, PV inspection preparation, PV crisis management, and PV training

Our goal in Sciformix Consulting is to advance PV across the industry so that drugs are developed and used in the most effective manner.  Sciformix PV Consulting is committed to partnering with clients and using our wide range of resources, expertise, and knowledge to meet this goal.