Transforming Clinical Trials: A Day With Signant SmartSignals® Marketplace

Imagine this: As a clinical trial manager at a bustling research organization, you’re working on a groundbreaking study. Every day, you juggle multiple electronic systems, from setting up trials in clinical trial management systems (CTMS) to managing supplies, capturing patient and clinician-reported outcomes, and shipping drugs to depots.

You meticulously maintain patient health records and document adverse drug reactions. In this digital age, the sheer volume of data can be overwhelming.

Amidst this complexity, there is a solution designed to bring order and efficiency—Signant SmartSignals® Marketplace.

Digital crossroads

We are at the crossroads of digitalization where data is generated at every step and collected in myriad electronic systems. However, the true power of this data is unleashed when these points connect, benefiting all users involved in clinical trials. Let's explore how Signant SmartSignals® Marketplace can revolutionize your workday:

• Seamless Integration: Imagine setting up a trial effortlessly, thanks to the integration of CTMS and RTSM systems. No more redundant data entry or delays.
• Eliminating Duplicates: Picture a world where capturing duplicate data in EDC and ePRO/eClinRO is a thing of the past. Efficiency and accuracy go hand in hand.
• Instant Access: Visualize having immediate access to trial data for statistical analysis and monitoring, accelerating your decision-making process.

However, with these advancements come new challenges—data security and privacy. In our industry, these concerns are paramount as we deal with sensitive patient data that must remain blinded, adhering to strict regulations such as 21 CFR Part 11.

Overcoming Challenges with Signant SmartSignals® Marketplace

How can Signant meet the demands of today’s clinical trials where data must connect across diverse systems while remaining compliant with stringent data privacy and security standards?

Real-Life Application

Consider a scenario where you are managing a study with 1000 participants and a short recruitment cycle. Your RTSM system must know as soon as the subject has given their consent via eConsent or has decided to quit trial. Likewise, you must update eConsent application with the participant ID as soon as the patient is randomized in RTSM. All these manual data exchanges can be automated via APIs, ensuring almost real-time data synchronization between eConsent and RTSM.

Unique challenges and our approach

APIs are the backbone of digital evolution, facilitating data exchanges between software components through well-defined contracts. However, without proper management, APIs can lead to inconsistencies in security policies, developer experience, and monitoring challenges.

Signant’s standardized approach ensures that our APIs are secure, scalable, and consistent across the board. Here’s how we do it:

• Authentication: A common subscription and identity management framework ensures seamless access across all APIs while all access controls reside with the subscriber.
• Authorization: Consistent authorization framework for machine-to-machine use cases, controlling user permissions effectively.
• Auditability: Comprehensive logging of all API requests and payloads for accountability and traceability.
• Standardization: Uniform API guidelines covering error reporting, endpoint naming, and versioning, simplifying integration.
• Data Quality: Domain-Driven Design ensures our system designs and data models meet business expectations. Platform-level services maintain shared data integrity across SmartSignals products.

Bringing it all together

Our Marketplace and the APIs create a cohesive ecosystem where value-added features and essential standardization come together. This ecosystem is your ally in the digitization journey, providing faster, more personalized experiences for site users, patients, data managers, and other stakeholders.

Imagine concluding your day knowing that every piece of data is securely managed, every process streamlined, and every decision backed by real-time insights. That’s the power of Signant SmartSignals® Marketplace—a pivotal tool in achieving your clinical trial goals.