Drug Safety Outsourcing Requires Careful Scrutiny of Pros and Cons

New Study Analyzes Data to Identify Factors Driving Decision-Making for Drug Safety and Pharmacovigilance Functions, According to Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - May 25, 2010) -  A new research study shows that the decision to outsource pharmacovigilance activities is connected closely to company size, cultural preference and internal skill sets. Findings are summarized at http://www.DrugSafetyBenchmarking.com/.

"As companies grow in size, they take on more pharmacovigilance responsibility in-house," said Jason Richardson, president of consulting firm Cutting Edge Information. "Every small pharmaceutical company we surveyed outsources some drug safety work, while 17% of mid-size companies and 56% of large companies conduct all of their pharmacovigilance activities in-house."

The study, "Benchmarking Drug Safety and Pharmacovigilance," also finds that the most commonly outsourced tasks are case management, IT services, and regulatory submissions; 56%, 43% and 36% of surveyed companies outsource these activities, respectively. These tasks require technical expertise that some companies do not possess in-house.

"Outsourcing pharmacovigilance activities often feels like a balancing act," said Elio Evangelista, director of research at Cutting Edge Information. "Companies need skilled drug safety personnel to monitor and report adverse events, but there are also vendors that can lessen the risk management burden placed on companies' internal organizations."

Pharmacovigilance vendors can support many activities critical to Drug Safety teams. Companies may outsource ad hoc activities or contract out all of their needs to a turn-key vendor. For drug safety teams, the decision to outsource can be driven in the short- and medium-term by the ebb and flow of their workloads.

Another factor behind the decision to outsource is a company's internal capabilities. Companies with strong IT departments may choose not to outsource drug safety teams' IT needs, whereas companies with inexperienced regulatory affairs teams may look for a vendor to help them with submissions.

The study is designed for drug safety teams who work with investigational drugs, post-marketed products, or both. It includes detailed budgets for drug safety activities and outsourcing, as well as structure, staffing, timing and communications best practices. Beyond providing quantitative analysis, the report includes top safety executives' creative solutions to ongoing challenges and their perspectives on current trends.

A detailed listing of key metrics can be found on the study website at http://www.cuttingedgeinfo.com/drug-safety/

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