Frequently Asked Questions – Pharma Solutions

Here are some answers to some of the most frequently asked questions we receive from sponsors.

Don’t see what you’re looking for? Submit your question below and we’ll get back to you.

  • What kind of support do you offer during the trial?
    • We provide a turn-key imaging solution and can manage your clinical study at every stage, from study start-up to close-out. Explore the full breadth of our CRO capabilities and services here.
  • How do you fit in working with clinical CROs?
    • In addition to our in-house imaging capabilities, we offer a full suite of services through partnering with clinical CROs. We have extensive experience working with various clinical CROs, and sponsors can suggest their preferred CROs for us to work with or vice versa. Our seamless data integration capabilities and expert, in-house project management enable us to easily collaborate with other study vendors.
  • Do you work on small studies?
    • Absolutely. We have worked on over 30 studies of all sizes throughout clinical development. We pride ourselves in offering scalable solutions that work for all clinical trials, no matter how big or small. Sponsors can rely on our extensive experience, operational excellence, and therapeutic expertise in clinical trials to help shape their strategy and optimize the use of imaging in their trial for improved clinical decision making.
  • Can you support large-scale clinical trials?
    • Yes. Our in-house capabilities and dedicated project management team enable us to cost-effectively scale our medical imaging solutions to trials of any size and handle the increased scan volumes of larger trials with ease. We were selected to manage over 100,000 individuals imaging data as part of the UK Biobank – the world’s largest, multi-site imaging study acquired over 5 years — proving we’re capable of managing imaging for over 51 patients per day.
  • How much does this service cost?
    • We offer scalable payment options with varying degrees of study management involvement to suit the needs of clinical trials at every phase of clinical development. Perspectum has preferential relationships and agreements that you can leverage to reduce imaging costs. Find out how including imaging in trials can reduce overall trial costs by booking a meeting with us today.
  • Is any software or hardware needed to be installed on the scanner?
    • Not unless you require MRE. Nearly all of our imaging biomarkers are delivered through a central read service with image processing occurring in-house. Although we don’t have to install additional hardware of software on scanners, our technology does have both hardware and software minimum technical requirements. Prior to setup, scanner specifications are discussed with our team to assess feasibility of enabling an imaging center's scanner(s). Get an assessment.
  • Where can trial participants get scanned?
    • We currently have over 300 active scanning locations around the globe. Explore our technology center map to find one near you. As we operate a software-based central read service that is scalable, we can easily add new centers that you want to work with and will work with you to facilitate activation of your preferred site list.
  • Is imaging safe?
    • Yes. MRI is non-invasive and generally a very safe procedure, with most people eligible for a scan. Our medical imaging services are patient-friendly and can be performed with little to no contact between the patient and healthcare worker. Absolute contraindications are metallic implants such as cardiac pacemakers and insulin pumps, as well as foreign metallic fragments including bullets and shrapnel.
  • How quickly can I get an imaging center activated for a study? How soon can I start scanning patients?
    • Imaging centers need to provide approximately half a day of time for setup & MR tech training. This can be delivered during off hours, including weekends if necessary, to limit down-time. Once an imaging center passes all requirements and quality control measures, patients can begin being scanned immediately.
  • How are scanners activated?
    • Although scanners can be activated remotely or in-person. We have expert Imaging Applications Specialists ready to perform in-person activation and training for imaging centers new to our technology, which helps minimize technical errors and patient recalls down the line. During the imaging center visit, the specialist inputs study-specific imaging protocols onto the console, and scan phantoms to calibrate the scanner and ensure inter-site standardization. The imaging center receives an Acquisition Manual as well as on-site MR tech training including human volunteer scanning. Anonymized, secure file transfer of data is sent to Perspectum’s imaging core lab via our secure data management platform. The site Tech then rescans healthy volunteer(s). Quality checks, verification, and final site sign-off is performed by the Perspectum Technical Team.
  • What medical imaging services do you offer?
    • We deliver a comprehensive range of integrated medical imaging services, tailored to fit individual study requirements. Explore which organ metrics we are able to characterize including the liver, spleen, pancreas, kidneys, heart, aorta, colon, and body composition.
  • What if you don't offer something I want in my trial?
    • We have worked with Sponsors in the past to provide metrics we don't already offer. Our world class innovation team of biomedical scientists and product developers are dedicated to adding new biomarkers to our portfolio in order to  accommodate your study needs. If we aren't able to implement the solution ourselves, we partner with only the highest quality third party companies and organizations to assist us.
  • How quickly can I get access to reports?
    • We can customize turnaround times to suit your needs. Reporting time is generally expedited during the Screening phase to notify Sponsors of subject eligibility quickly. Our central read service is delivered through the Perspectum Portal, enabling smooth workflow management after image upload. This reduces time by expediting the image analysis process and eliminating delays caused by physical imaging delivery.
  • Can you support trials in USA, North America, Europe, Asia-Pacific, and South America?
    • Yes. We have imaging center locations strategically placed around the globe ready and able to screen and enroll patients. Our technology and services are cloud-based and executed by a world-class team of leading imaging and clinical experts, offering round-the-clock support from start up to delivery.
  • How do you ensure that all your systems are compliant with applicable regulations?
    • We develop our software and medical devices in a controlled environment in compliance with ISO 13485, IEC 62304 and ISO 27001. We have an independent compliance team to ensure we continue to stay in compliance with all applicable laws and regulations, as well as adhering to the principles of Good Clinical Practice (GCP). We perform standards audits and gap analysis against regulations to ensure our systems, policies, devices and processes stay compliant.
  • Is your central read imaging Quantitative Analysis Service ISO:27001-compliant?
    • Yes. We receive raw images acquired by our trained imaging centres through a central read service with image processing occurring in-house within Perspectum and post-process them to produce quantified metrics of liver and metabolic health. All images are checked for quality and those that do not pass are sent to our in-house Imaging Applications and MR Physics teams for rectification. Every report generated by our core lab undergoes a review process prior to return.
  • What systems do you have in place to maintain quality management?
    • We are ISO 13485 and 27001 certified. This means we have fully implemented a strong Integrated Management System (IMS) and have successfully met all the requirements. Our IMS is periodically audited by independent third-party certification bodies which evaluate whether our IMS is appropriate and effective while considering, in particular, the safety, security and efficacy of our product and services. To maintain the healthiness of our IMS, the compliance team conduct several internal audits over the year.

Have a question we didn’t answer? Submit your question by email, or book a meeting with us to talk in more depth.