Expert safety and epidemiology reports, including legal reports. These are reports that critically analyze literature articles, reports, case series, etc.

Design and implementation of epidemiologic studies and portfolios. RMR has experience in the design and implementation of a variety of epidemiologic studies, both ad hoc or as part of a Risk Management Program.

Design and participation of oversight committees (e.g. DSMB).

Presentations to regulatory bodies worldwide. Risk Management Resources has experience in presenting safety/epidemiology data to regulatory agencies in the USA (FDA), Canada, Australia, and in various local European regulatory agencies and the CPMP.

Targeted training programs and organizational consulting.

Pharmacovigilance Plans (PVP).
A pharmacovigilance plan summarizes the safety profile of a product using data derived from pre-clinical development, clinical development, information about the class of agents to which the product belongs, and any safety issues that could be derived from the population expected to receive the product. In some countries this is known as “pharmacovigilance specification”. A PVP must contain a specific plan describing the steps that will be taken to gather knowledge on the safety profile of the compound after it is launched. This plan may include actions taken to characterize more clearly a known safety issue or to characterize the unknown safety issues that may arise because of the limitations of clinical trials. All pharmaceuticals in development should have a PVP.

Risk Management Plans (RMP).
The specific content of a Risk Management Plan (RMP) will vary from agent to agent. Some of the components of an RMP will overlap with the PVP. The main differences are that the RMP must include a section that would describe what steps a sponsor would take to minimize a known risk associated with a drug. The goal of an RMP is to minimize the risk associated with a product through five major areas of approach:

• Risk assessment/measurement: estimation and evaluation of risk.

• Risk confrontation: determining acceptable level of risk  (vs. benefit and intended population).

• Risk intervention: risk control action(s).

• Risk communication: interactive exchange of risk information.

• Risk Management evaluation: evaluating effectiveness of activities.

Risk Management Programs.
A Risk Management program consists of a series of activities, started early in the development of a pharmaceutical agent, that characterize, quantify and reduce the risks associated with the use of an agent. The PVP and RMP are the end results of a Risk Management Program.

Access to safety databases.
Risk Management Resources has access to a variety of databases, including the GPRD, THIN (The Health Improvement Network), the Veteran's Affairs database, and numerous U.S. health-claims databases including Constella Health Strategies, IMS Lifelink, and other large independent health plans. We warehouse our data using Oracle data stores and we use a number of statistical packages for data analysis including STATA and SAS. Risk Management Resources has also experience in mining and analyzing clinical data sets supplied to us by our clients.

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