Interview with: Tomasz Anyszek, Director, Synevo Central Lab

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Interview with: Tomasz Anyszek, Director, Synevo Central Lab, a sponsor company at the marcus evans Evolution Summit 2013, suggests a cost-effective way of getting clinical data harmonised.

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Interview with: Tomasz Anyszek, Director, Synevo Central Lab

  1. 1. Interview with: Tomasz Anyszek, Director, Synevo Central Lab “For clinical trial data interpretation and statistical evaluation, having a harmonised set of data is a must. However, what many companies do today is spend half their budget on shipping samples to a central lab, when a more cost-effective option is available,” according to Tomasz Anyszek, Director, Synevo Central Lab. From a sponsor company at the marcus evans Evolution Summit 2013, taking place in Monte Carlo, Monaco, 21 - 23 October, Anyszek gives an overview of what is challenging Chief Medical Officers (CMOs) of clinical trials and discusses the benefits of working with a network of local labs that use the same processes and procedures. How could CMOs enhance the quality of their clinical trial data? One of their biggest problems today is the harmonisation of data. Some companies use one central location to get results that are harmonised as they come from one lab. There are technical problems with this option, such as the high cost of shipping samples, problems crossing borders and permit or customs issues, which all result in a long turnaround time. Other companies use local labs that are close to the investigators, so everything is done quicker, but there is the big problem of having data from different labs. Must studies run on a central lab model because data harmonisation is challenging. For safety reasons, centralisation is a must for some studies. From our point of view, there is a third option, where trials utilise the services of labs located close to the investigators, but the procedures are fully harmonised between them. At the end of the project, they get a harmonised set of data that is almost the same as the set of data they would get by using one lab. This is the model we are able to offer. How does Synevo ensure data are harmonised? First, we have the same equipment in our labs and use the same testing methods, so results are comparable by definition. We are able to define one set of reference ranges, which is important for the interpretation of the results. We have the same quality control processes for the identical part of the work, in order to show comparability. Additionally, the procedures for kits production, and sample registration, resolution, rejection and shipment are the same. There are no differences between countries and investigators. We have at least one lab in each country we operate in that is harmonised with each other. What issues and costs does this avoid? If everything is within the European Union, it is not a big problem. You can send samples without permits and everything is well regulated. But for countries like Russia, Ukraine, Georgia, Turkey, Serbia, Moldova, you need applications and permits from the Ministries of Health. You have to pay a lot of money and wait to see what the customs officers will do. It is easier and cheaper to do it internally, as it is cheaper to ship nationally than internationally. Paying for shipment is a clear waste of money, because there is no quality or data in the service. I see studies where half of the budget went on shipment costs. This is clearly not how it should be. One of the simplest ways to reduce the study budget is to reduce the investment of the sponsor on shipping. It will not impact the quality of the data in any way. Big pharmaceutical companies may have the money to spend on this, but small biotechs need to count each euro. They should seriously reconsider whether the central lab model is the best choice for their project. One of the simplest ways to reduce the study budget is to reduce the investment of the sponsor on shipping Achieving Clinical Trial Data Harmonisation in Multinational Projects
  2. 2. The Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional t r e n d s a n d b r e a k t h r o u g h innovations. Please note that the Summit is a closed business event and the number of participants strictly limited. About the Evolution Summit 2013 This unique forum will take place at Le Méridien Beach Plaza, Monte-Carlo, Monaco, 21 - 23 October 2013. Offering much more than any conference, seminar or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on progressing clinical programmes, site selection, competing in the new drug development paradigm and winning market access. www.evolution-summit.com Contact Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: + 357 22 849 313 Email: press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.com About Synevo Central Lab Synevo Central Labs is the largest wholly-owned and fully-harmonized network of central laboratories in Europe dedicated exclusively to support clinical trials. Having an extensive menu of 1,500 validated assays, routine and advanced diagnostics, we are unquestionable leader in the region. We offer a comprehensive central laboratory services, starting from kits production through sample logistics and testing to results reporting with 21CFRPart11 proprietary software. www.synevo-centrallabs.eu About marcus evans Summits marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, case studies, roundtables and one-to-one business meetings. For more information, please visit: www.marcusevans.com Upcoming Events Discovery Summit (Europe) - www.discovery-summit.com Evolution Summit (North America) - www.evolutionsummit.com To view the web version of this interview, please click here: www.evolution-summit.com/TomaszAnyszek

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