SSS: CRO for Clinical Trials in Germany

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

21 July, 2021

Dr. Lars Behrend is the Chief Operating Officer of SSS International Clinical Research, a full-service clinical research organization (CRO) in Germany, specialized in providing clinical trial management services for biotechnology and pharmaceutical companies.

As an internationally operating CRO, SSS has managed clinical trials in nearly 20 countries. Starting with quality assurance services back in 1993 the company has successfully run more than 250 clinical trials and non-interventional studies to date.

In this interview with Lars, we will learn more about the clinical research panorama in Germany and how clinical trials are conducted in this leading country in Europe.

Patricio Ledesma (PL): Hallo Lars. It is great to have you in this interview. 

Lars Behrend (LB): Hi Patricio. Nice talking to you.

PL: Could you tell us about your professional background and your role at SSS?

LB: I have studied biology with specialization on biochemistry and cell biology. During my PhD and postdoc time I worked in molecular oncology. I am still fascinated by molecular mechanisms of diseases but I decided to change from university to the industry to work more on bringing the advances in molecular medicine to the people. My first company developed viral vectors to cure genetic diseases. Then I changed to my own consultancy firm to help Startups in strategic aspects and business development. After some time as advisor, I wanted to be back in a team. That is where Dr. Michael Sigmund, CEO and Founder of SSS International Clincial Research and I met. Clinical research fascinates me, as it is the last step in the long journey from basic research to, hopefully in the end, letting people participate in great new developments. At SSS I am currently the Chief Operating Officer (COO). Together with my team I care mainly about business development, proposal process and project budgets.  

PL: Germany is a top leading European country for clinical trials. Can you explain more about the great potential of Germany in clinical research?  

LB: Indeed, Germany is one of the leading countries in clinical research worldwide. We have top researchers and physicians, which are globally connected, so that the medical standards are very high. However, what is most important for sponsors: How fast can I get a trial started? Here German sites are much faster in their legal processes with site contracts than sites in the UK or in the US and – the investigator fees are still lower than in the US. In addition, the regulatory environment is beneficial for clinical research as the timelines for approvals are always kept and the regulatory processes are very transparent. In the framework of the European unification of processes, approval timelines will be even shorter and the process will be simplified. That opens up one unified continent with a large pool of patients with only one regulatory process. 

I may add a comment on medical devices (MD). Germany has been always a country of engineers and we have a very vibrant environment of mid-sized MD companies. In MD the European unification of rules and standards is a little bit behind pharmaceutical products. However, with the new medical device regulation, which will come into effect in May 2021, this will now change to more unified procedures like in the US. 

PL: What are some specific advantages of conducting clinical studies in Germany?

LB: The country is the biggest in Europe. So simply from the size there is an immense potential for clinical trials. Although there are many studies performed every year the potential for doing more is still there. This means that the competition for patients is usually not that high compared e.g. to the United States. In addition, we have a good public transportation and as Germany is densely populated, patients benefit from short distances to the sites. This also helps sometimes for a positive decision to participate in a trial. So, Germany combines good recruitment opportunities, fast start-up processes and an excellent health system.

PL: How can SSS help biotech and pharma companies planning clinical studies in Germany? What services do you provide?

LB: We have a large network for many therapeutic areas in Germany and we have an excellent reputation. Recently we asked sites via a web based anonymous survey about their satisfaction with SSS. Almost all sites were positive ranking our work as “very good” (66%) or “good” (28%). The brilliant standing at the sites really helps us to receive enough attention from the investigators and study nurses over the course of the trial. The results are excellent data quality and “in plan” recruitment rates. 

Regarding our services: We provide full service, all the way from project management, feasibility, protocol development, regulatory approval, site initiation and management, monitoring, data management, statistics, and finally publications and reporting the results. In some studies, we are also responsible for pharmacovigilance, medical monitoring or logistics of the medicinal product. Here we work sometimes with cooperation partners.

PL: Could you explain the timelines to have a clinical trial up and running in Germany?

LB: The time for the approval process depends very much on the quality of the application. To avoid delays by additional claims of the authorities it is of high importance that the clinical trial documents, like the study protocol, the patient information or the case report forms have been properly prepared. The authorities keep their timelines for approval processes and it takes about three months from application to approval. Overall, the milestone ‘first patient first visit’ can be achieved about six months after kick-off. 

PL: According to your experience, what are the key elements to ensure high quality data in a clinical trial? 

LB: At SSS we offer sites best possible support so that they feel accompanied throughout the study. This is essential to keep sites motivated and only a dedicated study team will deliver high data quality. However, there are several other factors: comprehensive and excellent training, experienced site staff and a well-structured and easy to handle eCRF. Finally, regular monitoring at the study sites by experienced CRAs guarantees that data are complete and of highest quality.   

PL: What is your experience with medical device trials?

LB: Currently inquiries for medical device trials are increasing and correspondingly the number of medical device and also in-vitro diagnostics (IVD) projects is on the rise at SSS. The new medical device regulation requests much more clinical data and we recognize this need in the market. As a specialist in this field SSS is currently running a cardiology project in eleven European countries as sponsor. 

PL: Could you give more information about your post-marketing study services and expertise?

LB: We are performing many post-marketing studies. Registry studies and observational studies but also big Post-Authorization Safety Studies (PASS) where the regulator demands to collect safety data of the marketed product. Especially PASS require high standards, almost similar to clinical trials. At present, we operate a PASS with 500 sites with 5,400 enrolled patients. During the study the sponsor asked us to take over an additional country in which they faced serious recruitment problems. We brought the recruitment back on track and managed to keep all timelines. 

The challenge in post-marketing studies is that usually there is a high rate of unexperienced sites. For them a study is harder to integrate into their everyday practice and they have only small teams. Then, it is important to provide an extensive support. 

PL: What is your top therapeutic area in terms of number of clinical trials performed with drugs?

LB: Since the inception of SSS almost three decades ago, we are very strong in oncology. We have performed many studies in solid tumor indications as well as in the field of hemato-oncology. Until today, we conducted several investigator-initiated trials in cooperation with European universities and study groups. Our customers can participate from our network of KOLs. However, we are also very strong in cardiology, inflammatory and respiratory diseases.

PL: Let’s suppose a large phase-3, pivotal clinical trial with 400 patients in Europe (4-5 countries), sponsored by a U.S. biotech company. Would you recommend using a large global CRO or rather a smaller, mid-size CRO working in collaboration with other CROs across Europe?

LB: Definitely, for very large international trials there is no way around big CROs. However, for example a project in five European countries with 400 patients can be handled by a mid-sized CRO with experience to organize such projects. Sponsors benefit from smaller contractors as they can react faster and be more flexible. We work in some projects together with big CROs and we sometimes hear complaints of the sponsors that big CROs are not flexible enough. At SSS we are used to handle pan-European projects. The biggest ongoing project is an oncology trial in 15 countries where we are currently in the follow up stage. Our own CTMS helps us in such big projects to keep track of all information by connecting all participating parties as CRAs, project managers, subcontractors, and sponsor. 

PL: Is there any additional advice you would like to give to sponsors planning clinical trials in Germany?

LB: I strongly believe that every clinical project is different and therefore it is of high importance to carefully choose the right European countries. It depends on many aspects like availability of patients and dedicated investigators but very much also on regulatory aspects and treatment praxis in the respective country.

PL: Lars. It was great to have this interview. Danke! 

LB: De nada – It was a pleasure talking to you Patricio. 

 

About SSS

As an internationally operating Clinical Research Organisation (CRO), SSS International Clinical Research has managed clinical trials in 25 countries. Starting with quality assurance services back in 1993 SSS has successfully run more than 250 clinical trials and non-interventional studies to date. Their clients are ‘big pharma’ (4 out of the top ten), biotech, diagnostics and medtech companies. As a full-service provider, SSS is covering every aspect of clinical research. SSS International Clinical Research is DIN EN ISO 9001:2015 certified.

 

For further information about conducting clinical trials in Germany, please contact us at info@sofpromed.com 

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com