Ventiv Technology

2 4 | 360º Aon eSolutions Founded in 1986 in the UK, the company now employs more than 4,000 people in over 28 countries. Shire has major operations in the UK, Switzerland, the U.S. and Brazil, as well as a network of offices and distribution channels throughout Europe, South America, Canada and the Pacific Rim. Shire is a dynamic company whose strategy is to meet the needs of patients, physicians and payors around the world through the provision of specialist, differentiated medicines that deliver real value to people's lives, to healthcare providers and to society. We spoke with Liz Oatten, head of Global Insurance, and Keith Jury, associate director, Global Insurance, about their use of RiskConsole to facilitate their clinical trial insurance process. quicker to Market is a coMpetitive advantage Patents are issued on novel drug compounds early in the drug development process. e subsequent exclusivity period varies by drug and territory and that exclusivity starts before clinical trials take place. Any delay in starting the clinical trial —such as a hold up in issuing and collating certificates of insurance— eats into that exclusivity period. patient treatMent reMains a top Motivator "There is also the moral aspect of getting drugs to market quicker," Liz commented. " With rare diseases like Hunter's, there may be no alternative treatment available and the quicker we can get the trial up and running, the quicker we may be able to get the product approved and more treatment available for patients. If the insurance can't be sorted out quickly, it can hold up the clinical trials for five, six or seven weeks." waking up froM the adMinistrative nightMare Shire embarks upon and commissions clinical trials in numerous countries to test drugs for safety and efficacy before they can be brought to market. As Liz explained, the clinical trial process can be an administrative challenge. "is is not just from an insurance perspective; our study managers have to pull together a lot of documentation to submit to the ethics committees in order to get approval to carry out the trial at a particular site," she said. "Delays in that process cost us money ; delays to the trial can result in knock- on delays to us getting a product to market and ultimately patients may suffer. So anything we can do to make the insurance part of the clinical trials process easier is obviously better. "is is where RiskConsole has enabled us to improve the insurance procurement process from taking several weeks to a position where we have coverage in place with all the necessary evidence at the touch of a button," Liz explained. "We now have audit trails, good management information and we have automated much of the process—basically transforming it from a paper-based system to an online process. It's been a huge advance in a short period of time." helping coordinate worldwide clinical trials "Before RiskConsole," Keith explained, "a study manager would tell an insurance coordinator within Shire that a clinical trial needed insurance. e coordinator would then fill out a paper form and send it over to the brokers. ere was no real reporting behind it. Some of the certificates were annual; some of them were for the length of the trial. One clinical trial may have patients across lots of different sites and in various countries. It would not be unusual to have many multi-center clinical trials ongoing at any one time across Shire. It made monitoring renewals challenging and resulted on a few occasions in our renewing insurance certificates at the last minute." "We also had many emails and attachments going back and forth for information because of the differing regulations in different territories, which was work intensive," he added. "When there is a trial for a rare disease there could be a few thousand patients in the world. It can be very difficult finding those patients for trials, so we may need to move very quickly to obtain insurance certificates for clinical trial sites in places like Peru or Paraguay or the Middle East. Each country has its own set of unique regulations to deal with, and RiskConsole makes it much easier to keep track and comply with them all." process iMproveMents and cost reductions "e system is allowing us to monitor deadlines for renewals or extensions of certificates, which is a great benefit," Liz commented. "Being able to track all aspects of the insurance for a trial also allows for a better understanding of the cost of clinical trial insurance." Keith added, "What RiskConsole does, for the first time, is to allow us to have one database of all the trials where policies or certificates have been issued for both of our divisions. We know premium costs, patient numbers and certificate end dates and we now have much better control over resources." "By looking at that, looking at RiskConsole and how we can use it, we have been able to more than halve the cost of clinical trials insurance to the group," reflected Liz. shire is one of the leaDing specialty biopharmaceutical companies in the worlD. focuseD on Developing meDicines for specialist physicians, shire Develops anD markets Drugs for the treatment of attention Deficit hyperactivity DisorDer (aDhD); gastrointestinal (gi) Diseases such as ulcerative colitis anD chronic constipation; anD rare Diseases such as fabry, hunter synDrome anD gaucher.

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