Safety/PV planning, staffing and process

The e-Clinical agency will participate in high-level strategy sessions, planning, budgeting and timeline determination using the many years of experience of our client partners.  Progress in building these functional areas will require an understanding of the development strategy of the candidate products as well as clinical trial plans, indications, marketing plans and targets and, most importantly the products’ expected safety profile. 

Working with the existing clinical organization, our e-Clinical partners will develop staffing plans, priorities, and timetables and can review job descriptions, duties and background and experience requirements. As critical safety group personnel come on board, e-Clinical partners will work with them to develop SOPs and outline the key processes for handling, escalating and reporting of various categories of adverse events.

For outsourced safety/PV partners, the e-Clinical agency will define requirements, write RFIs and RFPs and evaluate proposals to help select organizations that are aligned with sponsor priorities and possess the needed experience, expertise, and technical wherewithal and are cost effective.    

Subhead - Safety/PV regulatory climate

As clinical development matures and marketing strategies are agreed upon, it is important to turn more attention to the regulatory scrutiny and reporting requirements which will follow licensure in the various world markets.  e-Clinical partners have been deeply involved in representing the medical product marketing authorization holder in negotiations with the US FDA, the EMA in Europe, Japanese and other regulators to help the sponsor clearly understand safety/PV rules, reporting timeframes and aggregate reporting requirements and schedules.  Most regulatory authorities have adopted requirements around electronic reporting and are setting schedules for mandatory submissions using newer encoding standards such as E2B version 3.  

Adverse events that are serious, unanticipated or life-threatening, occurring in patients residing inside or out of the jurisdiction of the regulatory authority or involving conditions which are unlisted on the label often require special processing and timeframes.  Furthermore, database coding and terminology needs, as well as requirements around MedDRA and WHOdrug dictionary updates, must be understood and adhered to. The e-Clinical partner will provide expert advice on these issues.