Alexander Fetkovsky, managing partner at clinical research organisation SanaClis, and Dr Vladimir Misik, managing partner at data analytics specialist LongTaal and director of the LongTaal Institute, describe how the partnership between their respective companies is improving the speed, accuracy and efficiency of pharmaceutical trials.
Alexander Fetkovsky: SanaClis is a full-service clinical research organisation (CRO) specialising in Central and Eastern Europe, and has been in the market since 2001. Its geographic coverage includes not only Central and Eastern Europe but, through the exQuisite Alliance network, also other European countries and the US. SanaClis is preparing to expand its exQuisite Alliance into Latin America, Asia, Africa and the Middle East.
AF: In addition to its high-quality clinical monitoring services, SanaClis provides a wide range of other services including feasibility studies, clinical trial regulatory support, project management, data management, medical writing, and biostatistics, as well as functional resourcing. In addition to expertise in conducting phase I-IV studies, SanaClis has also built competencies in bioequivalence and therapeutic equivalence studies.
The company's unique services include IMP and clinical-trial-material storage and distribution depots in Ukraine and Russia, as well as its newly opened depot in Slovakia, which covers the EU; important to non-EU clients are QP services, which it can also provide. All of these are available, not only as part of the SanaClis full-service offering, but also as a component of the firm's stand-alone services. As an extension of its storage and distribution services, SanaClis offers comparator sourcing across EU countries, Russia and Ukraine, as well as IMP and study-material destruction across these countries.
However, geographic coverage and a variety of services alone are not sufficient for standing out in the crowded field of CROs. SanaClis strongly believes in continuous investment in technology, including the development of proprietary software solutions.
Vladimir Misik: LongTaal was founded in 2014 with a focus on big-data analytics for clinical trials. Combining large datasets from multiple data sources offers pharmaceutical companies, CROs, medical institutions, regulators and other government authorities, policy-makers, patient advocacy groups, investors and the media unique perspectives into the world of industry R&D clinical trials.
The insights that are gained can be used in multiple ways - including improvement of accuracy and speed of clinical trial planning (feasibility studies) to assess market potential, determine market-share of sponsors, focus business development activities, or gain unique insights; estimate current and potential clinical trial-related revenues; or research clinical trial demography.
I've provided only a few examples above: LongTaal is excited to learn how its clients are constantly finding new ways to use the data. As they do, the company will expand its service offerings to offer those insights to a wider user audience.
VM: LongTaal offers access to the data in two different ways: to customers who prefer running their own reports and performing their own research, LongTaal offers subscription-based online access to our LTTrialAnalytics platform, or to any of its main two pillars individually - LTTrialTrend (a global industry clinical trial trending and benchmarking module), or LTTrialPlan (a planning module for clinical trials).
LTTrialPerform comprises a bundle of performance-enhancing tools and solutions for product-development organisations. The LongTaal Institute provides personalised, expert services to customers who do not wish to perform their own research and would instead prefer expert interpretation of the data, customised reports or presentations and/or consultancy.
The LongTaal Institute advisory team consists of industry experts capable of preparing compelling reports and presentations by combining data from the LTTrialAnalytics suite with other available science and industry literature sources, all layered with their own expert views.
AF: The benefit has been identified across three main areas: first, thanks to market data that SanaClis was able to obtain from LTTrialTrend, its credibility as a small research organisation in the eyes of new clients has grown substantially, as it has been able to demonstrate detailed knowledge of the clinical landscape. On the basis of trust and interest from several new clients, SanaClis was later invited to present its full set of capabilities, and was ultimately awarded several new projects.
The second benefit of using LongTaal's big data was an improvement in the speed and accuracy of feasibilities, with an average 30% improvement in the former. Finally, LTTrialPerform solutions provided the company with internal performance-enhancing tools.
SanaClis is now able to assess the performance of its teams across a range of productivity, delivery and customer satisfaction metrics; drive areas of improvement; and recognise great performance.
VM: As a scientist, and later an executive of a large CRO, I helped LongTaal to design products that I was looking for, but was unable to find on the market. It is very pleasing to see that SanaClis, as a data-driven company, has quickly recognised the value of the products it delivers, and was able to harness this effectively to improve the company's performance. The feedback from SanaClis on the performance of LongTaal's products, and the features that it would like to see, provides a constant iteration process that helps us to improve our products and services. Ultimately, this process helps LongTaal to serve SanaClis better, as well as our new customers.