Solutions and services to generate quick, reliable results for decision making
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Phase I Clinical Trials
A unified technology platform ideal for phase I clinical trials
Comprehensive Technology Suite
Our Signant SmartSignals® Unified Platform combines all essential tools for Phase I research, fully integrated, including participant recruitment management, eConsent, direct data capture and EDC, randomization and more.
Simplicity for the Site
Site users love our truly unified platform. From a single sign on, sites can access all studies and all applications. Applications are integrated out-of-the-box, and site users enjoy seamless, converged, guided workflow between applications.
Rapid Set Up
Rapid full platform solution set up, typically in 4-6 weeks or less, using our intuitive designer that requires no-software coding. Our extensive library of re-usable forms and study templates speeds study solution assembly.
Reduced Training Burden
Our Unified Platform solutions are easy to use and intuitive. Guided workflow provides site operational efficiency. No need to learn multiple vendor solutions – all solutions are part of the same, single platform
Why choose Signant SmartSignals?
Experience
We’ve supported more than 700 phase I trials across many disease indications and therapeutic areas.
Unmatched Scientific Expertise
More than 50 full-time clinical and digital health sciences experts are available to support study teams from protocol design through study closeout.
Operational Agility
Our seasoned project teams help sponsors and CROs get high-quality results quickly with an eye towards later-stage success. Empowering self-service capabilities facilitates Phase I units to seamlessly integrate our solution into their operational workflows, fostering operational agility
Integrated Solutions
Fully integrated Participant Tracker, eConsent, EDC, and RTSM solutions can be deployed quickly. Optionally, pair them with eCOA and TeleVisits for a digitally optimized Phase I trial.
How our solutions digitalize & optimize phase I trials
- Informed Consent using eConsent
- Randomization Using RTSM
- Scheduling & Data Capture Using EDC/DDC
- Cognitive Safety Using CDR System®
- Remote Follow-Up using Televisits
- Patient-Reported Outcomes Using eCOA
- Participant Recruitment Using Participant Tracker
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Informed Consent using eConsent
Informed Consent Using eConsent:
Easily upload pdf ICF documents and include multimedia resources
Provide participant access to study information and ICF ahead of / during site visit
Improve transparency and quality of consenting documentation and eliminate inspection findings
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Randomization Using RTSM
Randomization Using RTSM:
Include randomization within EDC workflow – one click randomization from the same common, intuitive interface
Access rapid and transparent emergency unblinding
Incorporate demand-driven medication supply chain management, as required
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Scheduling & Data Capture Using EDC/DDC
Scheduling & Data Capture Using EDC/DDC:
Leverage direct data capture, and reduce SDV, through modern responsive design that can be used on any mobile device
Access study level and cross-study scheduling and activity calendars
Enable remote SDV to reduce on-site CRA visits
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Cognitive Safety Using CDR System®
Cognitive Safety Using Signant SmartSignals® CDR System®:
Assess treatment-related changes in attention and processing speed using Signant SmartSignals® CDR System®.
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Remote Follow-Up using Televisits
Remote Follow-Up Using Televisits:
Enable engaging follow up assessments using video meetings between site and participant
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Patient-Reported Outcomes Using eCOA
Patient-Reported Outcomes Using eCOA:
Easily collect integrated ePRO data when needed by the study – such as pharmacodynamic measures, formulation acceptability and taste, and reactogenicity
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Participant Recruitment Using Participant Tracker
Participant Recruitment & Pre-Qualification Using Participant Tracker:
Provide transparent management and oversight of patient recruitment and pre-screening activity/checks
Easily import contact lists from unit candidate database
Schedule site visits and auto-enroll in a selected study eConsent or EDC solution
FAQ
Why do Phase I clinical trials need eClinical technology?
Phase I clinical trials can gain the benefits of digitalization with electronic data capture (EDC), randomization, and electronic informed consent (eConsent) solutions driving rapid study start up, execution and data management. Using an integrated platform such as Signant SmartSignals(r) Unified Platform supports digitalization without slowing down trial operations.
What is Signant SmartSignals Unified Platform?
Explore the comprehensive suite of tools designed specifically for Phase I research, including eConsent, direct data capture, randomization, and more.
How does Signant SmartSignals® streamline Phase I trials?
Signant SmartSignals® streamlines Phase I trials by digitizing data collection, management, and analysis, ensuring real-time access to data and reducing errors. Alongside enhancing participant engagement through features like eConsent and remote monitoring, it also boosts operational efficiencies, expediting trial processes while maintaining high data quality and regulatory compliance.
How long does it take to set up Signant SmartSignals® for Phase I trials?
Discover the quick setup process, typically taking only 4-6 weeks, facilitated by an intuitive designer and extensive library of forms and templates.
Want to learn more?
Get in touch with us and see how Signant can support your next Phase I study.