Rising numbers of case studies and demanding legislation are forcing up costs for drug safety departments across the pharmaceutical sector. Anne Tinggaard of NNIT speaks to Clinical Trials Insight about the financial and logistical advantages of installing integrated IT solutions to optimise the pharmacovigilance process.
With patients’ lives hanging in the balance, drug safety is always paramount in the life sciences sector. For pharmaceutical manufacturers, it is a complex equation, necessitating compliance with tough industry regulations, data collection on adverse side effects and implementation costs.
Recently, the balance has become harder to strike; the number of side effects reported by patients is rising, creating an abundance of new information that costs time and money to collect and store efficiently. “People are starting to talk about drugs online and reporting adverse side effects on companies’ websites,” says Anne Tinggaard, drug safety consultant for NNIT. “The number of clinical trials required for product approval has also increased. Life science companies are required to file all this new information, which is pushing up the price of pharmacovigilance.”
Rigorous industry regulations are adding to the challenges. In 2010, the European Medicine Agency created a round of new legislation, including the Pharmacovigilance System Master File, requiring companies to supply vast amounts of information on drug safety procedures. In some cases, firms have been forced to take on new staff just to meet the demands.
Using IT to make case study processing more efficient and ensure regulatory compliance can help life science companies bring the cost of pharmacovigilance back down. But technology alone is not enough to provide an effective solution; field expertise is also needed.
“Being familiar with the daily processes of life science employees and how the life science business functions, along with having an in-depth knowledge of the latest legislation, is a vital foundation for any effective pharmacovigilance IT system,” Tinggaard explains. “Not only is it necessary for full optimisation, it also means the consultant has the necessary in-depth understanding to contribute new ideas to make processes run more smoothly.”
With a proven track record in hosting and supporting safety systems for a number of major pharmaceutical customers, NNIT has the experience and technological expertise to provide effective IT-based drug safety solutions. In addition to employing a number of staff who previously worked in pharmacovigilance departments, NNIT ensures its knowledge on the latest products and most recent legislation is always up to date.
“Some people mistakenly believe, because of our name, that we’re simply an IT company,” says Tinggaard. “But NNIT is a lot more than that. We understand the life sciences too, and are able to assist our clients on functional and technical levels.”
Improving drug companies’ business intelligence is central to NNIT’s strategy for bringing down pharmacovigilance costs. By providing technology that tracks key performance indicators (KPIs) for case processing across safety departments – including the number of studies, time spent, and ensuring requirements are met and that reports are sent to authorities on schedule – pharmaceutical companies can reduce the time and financial expenses of implementing drug safety.
“As consultants, we can come in, look at the daily work processes and figure out how best to optimise a company’s safety data,” says Tinggaard. “Also, a lot of companies are outsourcing their case processing now, so they need a more sophisticated IT solution to keep track of the KPIs.”
In future, cross-system integration looks set to play an even greater role in drug safety. With the number of case studies continuing to increase and regulation likely to become more rigorous, life science companies are beginning to combine clinical and safety data sets.
“It will become more important for the different departments of big firms to work well together,” says Tinggaard. “Not only does it create a good flow of information, it also allows companies to use computers to collect adverse effect signals a lot more easily.”
Automating the signal detection process also means that reported side effects can be reacted to far more efficiently than manual data analysis would allow, bringing significant financial and health benefits. For life science companies and patients alike, it seems the future of drug safety lies in integrated IT solutions.