Drug and medical device safety, as key components of clinical development, require specialized expertise, staffing, and systems.  Furthermore, the regulatory environment and reporting requirements regarding clinical candidates in the US, EU, Japan, and other major markets are evolving rapidly.  Post-approval and marketing pharmacovigilance monitoring and reporting introduce additional requirements and time-critical analyses which call for specialized processes and technologies. 

Building a safety organization, developing SOPs, recruiting staff, establishing communication with regulators and partners such as CROs and making decisions on outsourced services are major challenges to new organizations.  Ensuring the availability of safety data and best use of resources and finances can be critical in keeping candidate medical products on track for regulatory approval during clinical development.

The e-Clinical Agency will advise growing organizations in the safety/PV realm, recommending organizational structures, processes, technologies and platform options to establish optimally and cost-effective means of compliance. Beyond strategies to meet needs for normal adverse event case processing, our client partner can provide expertise concerning analytical techniques and systems to help anticipate safety issues and find and evaluate patterns and safety signals in pharmacovigilance data.