Central Site Management

from feasibilty up to close out

We are the central point of contact for you when selecting the right site for your study.
From a single source you obtain a group of professionally set up and qualified sites, which have extensive experience in conducting clinical studies and a high patient potential.
All our processes run centrally, are effectively coordinated and enable you to process your request quickly.

We act as link between our sites and Sponsors worldwide.

Centralized Feasibility Management

The feasibility requests for our sites are managed centrally by our feasibility assistants or our feasibility managers. This means we offer you a list of potential study sites from our network for your specific study request. Based on our detailed information about our doctors and their respective sites, we can process the feasibility for several study centres within a few days. Our network allows us to make a quick, qualitative and realistic assessment.

Centralized Contract Management

Bringing the opposing interests of our contracting parties to a common level is belongs to one of our most important concerns.

All our contracts are managed centrally in our headquarter in Leipzig with the aim to develop as much standardization as possible.

For example, if you have selected several SIGAL SMS sites for your study, we endeavour to create a contract that covers all SIGAL SMS study centres. This saves time as the effort for contract negotiations is significantly minimized.

Centralised Budgeting

Our team determines the study budget based on our numerous empirical experiences in coordinating and conducting clinical trials with a huge amount of several indications. All calculations will be coordinated and finalized in close collaboration with our network sites. Due to our long cooperation and the trust we have gained, our sites rely on our knowledge in this specific area. Your advantage: this step in conducting your specific clinical trial will be executed in the most efficient way as processes will be streamlined.

Centralized Recruiting Support & Concept Development

The special feature of our network is an extensive database of a total of more than 655,000 patients in Germany. We know how many patients with certain diagnoses are cared at each of our study sites. We can answer your specific recruitment questions without long term processing times. In special cases, we get the information from our network specialists quickly and reliably.

All our network doctors know their patients personally and caring for them for several years already. This intense doctor-patient relationship has the advantage that we have high inclusion rates and can minimize the dropout rates even in long-term studies.

Additionally, before starting a clinical trial, our recruitment team develops a study-specific concept, which suggests actions for the recruitment of patients for the respective sites and supports them in their implementation.

This concept will be coordinated with you as Sponsor or CRO before your clinical trial starts. Depending on the possibilities, these recruitment concepts can include various innovative recruitment strategies such as online recruitment, online marketing campaigns via social media, organization of cooperation with the referring doctors, including support by our field service, an advertising campaign or other. In this specific task within your clinical trial, we refer on our long-term experiences and know which options are the most effective ones in certain areas.

During the duration of the project, the recruiting success of each individual action will be evaluated regularly and adjusted accordingly. In this way, the central control of recruitment ensures the success of each individual study and minimizes effort.

Project Management

At SIGAL SMS, you will have ONE responsible project manager for each individual project. Our related Project Managers are the central contact person and take care of each kind of communication with you as Sponsor or CROs. Furthermore, it is the task of our project management team to continuously ensure all the fundamentals at our sites in order to ensure successful and qualitative recruitment for your study.

Project management additionally supports both - our clinical research sites and the CRAs, which often must serve large areas and cannot always react immediately. This direct communication supports us in identifying risks or potential problems as soon as possible, and to develop action strategies to solve them immediately. Our team is characterized by our proactive and solution-oriented way of working. You benefit from our expertise and are supported by an experienced and qualified partner.

Quality Management

In order to ensure a permanent quality of all studies, the team of SIGAL SMS is reviewing all operational processes at the network sites regularly, independent of current projects and clinical trials.

We develop and record respective SOPs for each of our network sites. These SOPs are defined centrally by our headquarter in Leipzig and adapted to the particularities of the individual site. We lay the foundation for standardized processes at each SIGAL SMS network site while taking site-specific individuality into account.

We regularly conduct internal audits at our clinical research sites. They serve for quality control and the improvement of processes.

Privacy

With the implementation of the General Data Protection Regulation on May 25, 2018, this area has become more important than ever in our everyday business. We support our sites in the creation of templates for dealing with their patients and are available to advise them. Soon, the development of a standardized data protection concept is planned for all our network sites.

Your contacts

Helena Sigal
+49 (0)341 962 800-0
Helena Sigal MD, Founder and Owner

Tel: +49 (0)341 962 800-0

E-Mail: kontakt@sigal-sms.de

Kathleen Peters
+49 (0)341 962 800-0
Kathleen Peters Director Business Development

Tel: +49 (0)341 962 800-0

E-Mail: kathleen.peters@sigal-sms.de