Our Services › Other Services

More than statistics, programming and data management

Significance is specialized 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.

Survey design

If you want to learn more about people's traits, opinion, behaviors, or preferences we also offer quantitative/qualitative survey design including Discrete Choice Experiment (DCE) method.

Survey design can be customized, and our team of experts can help you shape the survey’s questions that fit best to your research hypothesis.

Well-designed survey allows you to get profound knowledge and can give your businesses access to a vast information bank.

  • "Signifikans, you are our competitive edge."

    – Head of Clinical Development

  • "I truly enjoyed working with Signifikans and have only good things to say about my cooperation with them. They are indeed a company that engages in their work with their clients. Signifikans is service-minded, flexible and does have the competencies to provide you with the right solution.”

    — Clinical Project Manager

  • "CLIN-LINK is really easy to use!"

    – Senior Clinical Trail Associate

  • “Signifikans have shown good flexibility during the project and showcased that the costumer is in focus. Objectives has been completed fast and on time without compromising the quality. They will be on our mind for potential collaboration in our next project.”

    – Medical Liaison Manager

  • “Signifikans have been a pleasure to work with on our clinical study. Their team are helpful, efficient and readily available to answer any questions we have! Complete professionals and would hope to work again with a great team and platform.”

    – Clinical Project Manager

  • "Collaborating with Signifikans I’ve experienced skilled and thorough data managers that goes the extra mile to secure high quality and adherence to GCP and other relevant guidelines. Their (Signifikans) statistical expertise and structured processes are crucial to secure the relevant quality we expect from our research and research collaborations."

    – Senior Clinical Development Scientist