Oncology trials and populations bring unique challenges that comprehensive trial technologies can help address.
Optimizing Oncology Trials
Oncology Research Landscape
For 25 years, sponsors and CROs have relied on Signant’s science-led solutions, and clinical and operational expertise, to optimize trial design, conduct, and evidence generation in oncology research.
Creating new, innovative cancer treatments, and ensuring their rapid approval and access, presents distinct challenges for all stakeholders involved.
Some of the challenges include:
Early Phase
Accurately characterizing dose-response relationships in early phases to drive optimal dosing
Complex Studies
Implementing and managing complex study designs such as cohort studies, seamless adaptive (phase I-II) trials, and master protocols (basket and umbrella designs)
Patient Perspective
Increased emphasis on capturing and incorporating the patient perspective
Regulatory Needs
Navigating rapidly evolving regulatory requirements and guidance, especially related to patient-reported outcomes
How Signant SmartSignals solutions address
oncology trial challenges & goals
eClinical technologies are an indispensable component in bringing efficiency and accuracy to today’s clinical trials, but thoughtful application is vital for success. Signant SmartSignals® is a comprehensive eClinical solutions suite addressing key challenges and goals associated with oncology trials, supported by an experienced scientific team, ensuring streamlined processes, generation of high-quality evidence and insights, and optimized study management.
- Simplify the Management of Complex Trial Designs
- Empower Trial with Early Phase Tolerability Evidence
- Generate High-Quality Evidence and Drive New Labeling Claims
- Deliver a Supportive and Empathetic Patient Experience
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Simplify the Management of Complex Trial Designs
Simplify the Management of Complex Trial Designs
Oncology trial designs often bring unique challenges for implementing randomization and ensuring trial medication is always available in the right place. Complexity arises from study designs including cohort studies, seamless adaptive phase I-II trials, and master protocols (including basket and umbrella designs); and also from treatment-related factors such as managing variable dosing regimens, treatment interruptions or reductions, and unpredictable visit schedules.
At Signant Health, we understand these intricacies and offer a comprehensive solution to simplify their management. Our configurable and flexible RTSM solution facilitates robust and accurate randomization, for even the most complex study design, supported by our in-house team of implementation experts. Moreover, our proven, reliable, and agile medication supply chain management solution ensures seamless control of local and centrally sourced standard-of-care medications and the ability to accommodate treatment interruptions or reductions and variable treatment periods.
With Signant Health as your partner, you can confidently navigate the complexities of oncology clinical trials and drive successful protocol implementation. -
Empower Trial with Early Phase Tolerability Evidence
Empower Trial with Early Phase Tolerability Evidence
While patient-reported outcome measures (PROMs) have been currently underutilized in early-phase clinical trials, they are becoming a vital element to help characterize the dose-tolerability relationship and select the most effective doses of treatment for later phase trials.
However, collecting tolerability data is more complex in early phase where less is known about the drug. However, Signant's innovative ePRO solutions are designed to provide a comprehensive assessment of tolerability in early-phase studies.
By integrating PROMs into early-phase protocols, we empower researchers to make more informed decisions and optimize the trajectory of oncology drug development.
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Generate High-Quality Evidence and Drive New Labeling Claims
Generate High-Quality Evidence and Drive New Labeling Claims
To meet the evolving regulatory landscape and drive new labeling claims, Signant's scientists are dedicated to implementing a thoughtful patient-reported outcomes (PRO) measurement strategy aligned with FDA guidance and meeting the needs of other regulatory and HTA stakeholders.
Our solutions help sponsors to drive the collection of highly specific measures, with optimal frequency to generate informative data and drive decision making.
Our thoughtful solutions are designed with the patient in mind, ensuring low burden and generating high quality and complete data.
By generating the highest quality clinical evidence, our solutions provide comprehensive insights to inform regulatory decision-making and support medication labeling claims.
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Deliver a Supportive and Empathetic Patient Experience
Deliver a Supportive & Empathetic Patient Experience
At Signant Health, we optimize clinical trial technology implementation to simplify participation for patients and sites. We achieve this through thoughtful application of clinical trial technologies. For example:
- Enabling patients to complete patient-reported outcomes at home to reduce clinic visit times and enhance the in-clinic experience for both patients and site staff.
- Using eConsent to enable patients to review and flag questions on the study information at home leads to a more focused in-clinic consenting visit, and a less rushed decision-making process.
- Using telemedicine enables routine follow up visits to be conducted remotely, when appropriate, reducing the time associated with clinic visit attendance.
Our thoughtful approach to technology implementation aims to streamline the clinical trial process, making it more accessible and accommodating for patients undergoing oncology treatment.
Our Oncology Experience
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Advancing Oncology research through science
Meet our team of subject matter experts, spanning diverse therapeutic areas, who offer invaluable guidance and insights to shape the landscape of oncology research and beyond.
Areas they advise on:
Study design | Outcome measure selection | eCOA modality choice | eCOA design | PRO dossier support | Data quality monitoring & analytics | Wearables & sensors | Selection and implementation | Innovative technology and novel endpoints
Explore resources for oncology clinical trials
FAQs
What are the key challenges in oncology clinical trials?
Oncology trials face complexities such as adaptive or basket trial designs, rapidly evolving regulatory requirements, and the imperative to incorporate the patient perspective effectively.
How does Signant SmartSignals® address challenges in oncology clinical trials?
SmartSignals offers a comprehensive suite of eClinical solutions tailored to meet the unique demands of oncology trials. From robust data management to streamlined processes, our solutions ensure optimized trial outcomes.
What tools are available to streamline Phase I oncology trials?
Signant SmartSignals® provides cutting-edge technologies including EDC, eConsent, RTSM, optional eCOA, and cognitive assessments to set Phase I trials up for success.
How does Signant SmartSignals® ensure the generation of high-quality evidence?
Our SmartSignals® Unified Platform, backed by global teams of experts, facilitates the generation of reliable endpoint data, ensuring submission-ready evidence for oncology trials.
Does your eConsent solution offer data integration tools and clinical data exchange with other systems?
Signant’s eConsent solution offers integration with our other clinical data solutions from our SmartSignals product suite, as well as with other eClinical systems.
Want to learn more?
Let our experts optimize your oncology protocol with tailored clinical trial technology and services to enhance study outcomes.