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More than statistics, programming and data management
At Signifikans, our expertise goes beyond statistics, programming and data management. We specialize in leveraging data-driven strategies and cutting-edge technologies to optimize clinical research processes. Here are the comprehensive services we provide to support pharma, biotech and medico companies in conducting efficient and compliant clinical trials.
Data Monitoring Committee (DMC)
We make sure that assessment of the safety, scientific validity and integrity of clinical trials is done in the most effective ways. We deliver data packages that contain all relevant tables, figures and patient profiles directly to the DMC Members in a safe and simple way via CLIN-LINK. Our service also include planning the meetings and managing all relevant documentation so you can concentrate on the other tasks.
Clinical Data Visualizations
As a data-driven company we understand the critical role that insightful data visualization plays in informed decision-making and maximizing the potential of clinical trial outcomes. We offer tailor-made clinical data visualization service that alignes with your specific trial objectives and helps to understand and interpretate trial results. You can quickly and efficiently get the meaningful information you need from your clinical data that, in turn, will allow you to make any corrective action if data anomalies are discovered.
Medical Writing and Documentation
Our medical writers team combines scientific expertise from academia with exceptional writing skills to deliver documents of the highest quality and integrity. We can help you creating essential trial documents, such as study protocols, Informed Consent Forms (ICF), Investigator's Brochure (IB), Clinical Study Report (CSR), Scientific Abstracts and Manuscripts and others based on your current needs. We prioritize compliance with regulatory standards, ensuring that all documents are thoroughly prepared, accurate, and aligned with relevant guidelines and requirements.
Electronic Trial Master File (eTMF)
Our eTMF management system streamlines document handling, ensures regulatory compliance, and enhances overall trial efficiency. We implemented fully validated solutions that allow for secure 24/7 remote access to your eTMF. It is 100% Web-based with no installation needed and is GCP and GDPR compliant. Our eTMF solution can be based on the DIA Reference Model, ISO14155, or can be fully customized based on your requirements and needs.
Consultancy and Advisory Services
Our experts in data management, statistics and statistical programming provides consultancy and in-depth expertise in oversighting every aspect of your clinical study from the planning phase throughout the study maintenance and supervisory of data collection to the analysis and interpretation of clinical data. We can be your external voice advising and guiding you through the entire process.