prostate-heart

Trial Services

We bring extensive expertise in strategic use of clinical imaging to quantitatively assess the efficacy of new drug candidate and to increase the objectivity of early go / no go decisions. We leverage 10 years of expertise in advanced image analysis, global footprint and our proprietary next-generation cloud Imaging Trial Data Management platform Dynamika to accelerate drug development, de-risk trial execution of trials and to ensure integrity and scientific credibility of your data.

We partner with our bio-pharmacutical clients to understand their clinical hypotheses and propose a complete solution, which includes the planning, designing and delivering of a clinical trial or the entire clinical programme. We bring together highly experienced regulatory teams, clinical R&D teams and operational teams to discuss the structure and execution of the clinical programme.

Our services include development of relevant study documentation, selection  and qualfication of imaging sites, imaging data management with our proprietary cloud-based platform, image quality control, centralized read and final statistical analysis and submission.

Protocol design

Our dedicated team and clinical advisory board are the world’s recognised experts in using quantitative imaging in clinical and research studies. With over 100 years of combined experience and 2000+ publications in the field of clinical research, we ensure that the protocol, imaging protocol, reading methodology and the final outcome measures are adequate to give an the earliest possible indication of the treatment impact and comprehensive profile for a new drug candidate. We utilize precision medicine and adaptive trial design methodologies to support  early phase studies and state-of-the-art FDA approved biomarkers to cost-effectively deliver phase III trials.

Rapid Site Selection

Through a propriety database of over 2,000 qualified sites in over 60 countries and 80+ board certified readers, we ensure that the clinical investigators are connected with the imaging sites to deliver a trial of any size and within any geography using a sub-selection of dedicated, highly experienced sites with the optimal equipment and capabilities.

Image Quality Checks and Protocol Compliance

Fully and semi-automated quality checks are conducted to ensure reproducibility of imaging data across the scans and at multiple time points. As early as the imaging data is acquired at the imaging site, automated protocols ensure compliance to the study protocol and completeness of the exam. Fully automated data de-identification, paper-less logistics and quality control are put in place to ensure the most efficient site communication  and data quality control.

Training Programmes for Sites and Readers

Image Analysis runs dedicated educational workshops on using quantitative imaging in clinical practice and research as regular webinars and conferences. For early phase trials, we offer face to face site training or central training through webinars. For late stage studies, we offer a proprietary training programmes designed to reduce data discrepancies and ensure comprehensive use of advanced methodologies for trial protocol complience.

Central Data Reading

With machine learning techniques, artificial intelligence and deep learning methodologies, we transform medical image reading from subjective art to a quantitative science and deliver sensitive and reproducible data to measure therapy response. All readers in our database of over 400 board certified radiologists have the knowledge and hands-on expertise in using the latest techniques and algorithms to improve the reproducibility of the outcomes and ensure the most sensitive biomarkers are used to measure the impact of treatments.

Cloud-based System for Trial Data Management 

All trials will benefit from the use of the proprietary cloud based platform Dynamika, designed to seamlessly connect all stakeholders, including the sites, readers, project managers and other suppliers. Dynamika’s dashboard package gives complete visibility to the trial performance progress as well as ensures that all queries  are dealt within the shortest possible time.

What Our Clients Say

  • I feel strongly that by making Dynamika available, student researchers could come up with very interesting and meaningful quantitative projects. Laura, Radiographer
  • Dynamika is really fantastic! Salvatore Costantino, Post Doctoral Researcher, University of Sassari, Italy
  • Dynamika is key to precise and accurate early diagnostics and a powerful tool for follow-up of post-op and post chemo and/or radio treatment patients. Roman Marin, Head of CT and MRI Department
  • I am a clinical-research fellow with high experience in prostate MRI analysis and reporting. I have been using Dynamika mostly to help the analysis support team to develop a PI-RADS structured reporting user interface.
    The software is extremely useful and has the potential to be used in daily clinical practice. One of the most important skills of Dynamika is the capability of providing high quality tools to report prostate mpMRIs together with the possibility of assessing quantitative analysis at the same time.
    Therefore, Dynamika opens a new window in the use of automated and semi-automated algorithms both for clinical and research purposes.
    The integration of these two aspects is further strengthened by the remarkable competence of the support team that is constantly willing to help me when necessary.
    I hope to keep on working with Dynamika and taking advantage of all its valuable tools during my clinical-research practice.
    Francesco Giganti- Clinical Research Fellow, University College Hospital, London, UK
  • We have been using Dynamika software to analyse DCE data as part of a research project using multiparametric MRI for targeted radiotherapy treatment planning. We have found the software extremely useful compared with software delivered with our MRI scanner for a number of reasons, in particular: the ability to control each stage of the data processing, the ability to assess image quality and examine the parametric and pharmacokinetic maps in detail. Our project requires a quantitative (rather than qualitative) analysis of the DCE data and we have been very impressed with the collaborative approach of the Image Analysis support team in helping us achieve our goals. In addition, we commend the support team in providing informative and responsive training sessions and willingness to develop the software to meet the needs of our research project. Hayley Reynolds, Research Fellow, The Peter MacCullum Cancer Centre, Melbourne, Australia

Certifications