Despite increasing consolidation in the clinical trial industry, there’s enough market share to go around says SOCAR Research CEO Bridget-Anne Kirwan. For SOCAR Research, it’s the company’s strong academic roots in addition to personalized, tailored and innovative services that have helped to make the difference.

To begin, could you please introduce yourself and SOCAR Research?

SOCAR Research was first started in the Netherlands as an ARO back in the late 1970, and then was moved to Switzerland in 1986. SOCAR actually is an abbreviation for Society for Research in Cardiology, and thus SOCAR’s core focus was initially in the cardiovascular and cardiovascular related indication areas. The latter are still key therapeutic areas for SOCAR today but since 2000, we’ve spread our reach to other indication areas such as ophthalmology, oncology, metabolic (including diabetes and lipidology), nephrology, gastroenterology, Nutraceuticals and medical foods.

Last year we celebrated 30 years in Switzerland, and today we are proud to serve the academic community and life sciences industry as a mid-sized Functional Services Provider (FSP) with our eclinical solution – eSOCDATTM and our high-quality clinical trial services

What relationship does SOCAR Research have with the academic research community?

Going back to our ‘roots’, SOCAR has a strong scientific and academic background. Personally, although I joined SOCAR Research back in 1993, I am still active in academia as a senior lecturer at the London School of Hygiene (University College of London), and also hold teaching positions at the University of Geneva and in Berlin. Keeping close ties with academia and those clinicians who have a real impact on research in their fields is an important aspect of our business, and as such we are known and well reputed within both the academic world and life science industry for our scientific expertise, and also for our network of collaborators who are true leaders in research within their field.

What would be an example of how your scientific and academic background helps to differentiate SOCAR Research from an FSP or CRO without these attributes?

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A great example would be that together with world renowned clinical experts we have initiated many randomized controlled trials (RCTs) of varying sizes and duration. There are still a multitude of unmet clinical needs that necessitate research to be done and together with our network of world renowned clinical experts we can make such research happen. Together, we can develop the concept and present it to a potential sponsor – and then take the lead in developing a study protocol, recruiting sites, and then running, managing, reporting and publishing on the study.

This was how the ACTION trial came to be, as this was an 8,000 patient trial investigating clinical outcomes of patients with coronary disease being treated with nifedipine GITS, where SOCAR Research developed the concept and managed the study from A to Z together with our network of renowned clinical experts and the Sponsor. We were very proud to report and publish the main results of this landmark trial in the Lancet. SOCAR went on to publish more than 27 other publications/presentation on this large and unique database.

Given the high costs of operating in Switzerland, efficiency is a key factor of success for Swiss companies. What steps has SOCAR Research taken to be more efficient?

Certainly, labor costs are higher in Switzerland than in the US and other EU countries and the strong Swiss Franc certainly hasn’t helped. However, one needs to look further than just at deliverables per se – it’s important to look at what one gets for the price paid. We feel that in terms of the quality of services delivered, the significant insight and assistance which we provide while going the extra mile, that the overall package we offer is a very good value proposition. We take pride in high quality standards and personal customer service. Our commitment and pursuit of perfection mean our customers can rely on us as their long-term partner of choice.

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There are a number of things that SOCAR Research does perhaps differently to be as efficient as possible while still delivering high quality services. One of key areas where delays can occur is the time from database lock to the getting the results out and published and it is not uncommon for this to take anything from two to six months; SOCAR Research has a very efficient system in place such that we can almost get the study results out within very short timelines following the last patient’s last visit thanks to our efficient and highly sophisticated data management process implemented for our trials. When it comes to publishing, we also prepare the shell of an article prior to the final results becoming available, so that we can finish the article and have it ready for publication very soon after data base lock. Time is money, and in many cases clients feel that receiving results substantially earlier is well worth any difference between our prices and those of other FSPs or CROs they may consider.

Innovation is another very Swiss attribute. How has SOCAR differentiated itself from other FSPs and CROs by innovating new solution?

SOCAR Research has developed in house our own eclinical solution eSOCDATTM. eSOCDAT has been developed by SOCAR’s clinical trialists with many years of ‘hands-on’ clinical research experience – it is a fully validated and regulatory compliant innovative eclinical solution integrating into one database the full spectrum of functionalities for the setup, conduct and reporting of any clinical research study. eSOCDAT is intuitive, easy to use and minimum training is required. All stakeholders can easily manage, track and control deliverables and thus is structured in such a way that it is very efficient for different stakeholders to use.

This differentiates SOCAR Research from most other CROs or FSPs in several ways. First, few FSPs have developed their own eclinical solution, and most use systems developed by software companies which are “one-size-fits-all” and don’t always fit the client’s needs very well. Second, The eSOCDAT modules are interconnected thus optimising performance and productivity while maintaining high quality standards. The exhaustive suite of modules which include Event Adjudication, DSMB management, Deviation tracking, eTMF, Payment tracking, Site selection, Site management, Submission tracking, Site contact tracking and Report creation, cover all activities relating to Patient, Site and Overall Study Management thus providing optimal efficiency and productivity ‘at the tip of a finger’. Most other systems can only handle a portion of these issues, and it would take at least four separate off the shelf systems to manage all of the same data and materials. Moreover, eSOCDAT is also flexible and thus can be tailored to fit the specific needs of each study.

As such, our eSOCDAT system is very favorably perceived by our commercial and non-commercial the stakeholders including some of the big academic units at leading US, European and Canadian universities. The users can see that it was built by clinical trialists and that we put a lot of thought into how to do things in the most efficient manner while developing it.

The ever-expanding multinational CROs get much of the attention in the clinical trial space. How does SOCAR Research, as a midsized FSP differ from these giants, and what’s your competitive edge?

Like most Swiss companies, our calling card is quality. In clinical research, the most important thing is that your data is reproducible, reliable, and of the highest quality because at the end of the day data derived RCTs will be used to improve patient care. At SOCAR, we strive to establish long-term personal relationships based on mutual trust, reliability and genuine commitment. Delivering a tailored, premium quality service that exceeds expectations is so important to us. We understand that our clients have individual needs so we offer tailored solutions. Our commitment and pursuit of perfection mean our clients can rely on us as their long-term partner of choice.

Our focus as an FSP is on creating real value through being involved in the more scientifically rigorous aspects of clinical trials, and thus it’s by choice that we did not grow into a ‘massive workforce’ just to monitor trials, and instead chose to remain a “human sized” organization. Moreover, while we may be considered as a ‘small’ organization, SOCAR Research is a highly efficient company with a very stable workforce of a multidisciplinary team of experts all with many years of experience in some form or shape of setting up, conduction, analyzing or reporting of clinical trials– and thus our clients know that they will get timely service from us, and that their point of contact will very likely remain the same throughout the duration of a multi-year study.

There is enough market share to go around, and for the most part the large CROs attract large big-pharma clients. As a smaller FSP we are in a better position to attract and work with smaller organizations, like academic research teams and small to mid-sized pharma/biotech companies. Moreover, collaboration is common in the clinical trial sector, and as an FSP we might provide certain services – data management, statistical analysis, and medical writing for example – for a study while another FSP or CRO could manage other aspects.

SOCAR Research is a member of the Health Valley of Switzerland and the BioAlps association, which have several members who are themselves innovative startups. What are your priorities for SOCAR Research over the next five years, and how do these local innovators in Western Switzerland fit into the picture?

We have a close link with the Health Valley organization and its director Dr. Benoit Dubuis, and we are certainly known as an FSP in the area. Many of the innovative companies within the Health Valley organization are at an early stage of development and are not yet to the point of needing clinical trial services, however we look forward to the opportunity to working with these local innovators when the time comes.

Until that time, SOCAR plays an active role in the Fondation INARTIS which provides advice and support to companies that are at a very early stage of development. The issues we can help with are around design, various regulatory aspects, and of course planning, as many of these entrepreneurs do not know exactly how the research process will go and may not realize some of the issues they may come to face ahead of time. Thus, through the Fondation INARTIS we help to advise them on how to plan in a time and cost effective manner, so things are done right the first time and time isn’t lost.

I would hope that in five years’ time that SOCAR Research will continue to help these companies achieve their goals, by helping them to do quality research. More broadly, SOCAR’s aim is to continue to do what we do today – i.e. develop long-term personal relationships based on mutual trust, reliability and genuine commitment and continue to deliver tailored, premium quality service that exceeds expectations. We would also like to continue to expand our presence and increase exposure to eSOCDAT within Pharmaceutical/Biotech and Academic environments.