Articles, App Notes, Case Studies, & White Papers
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RTSM And Clinical Drug Dispensation
7/16/2024
A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.
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Real-World Evidence - Where Are We Now?
8/24/2022
Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.
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A Checklist For Good TMF Health
10/16/2023
The Trial Master File serves as the central repository of documentation. Utilize this guide to better concentrate on critical considerations and safeguard the well-being of your TMF.
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Readying Your Clinical Trial For Linkage With Real-World Data
9/20/2022
Discover why the near ubiquity of real-world data (RWD) sources has prompted sponsors to consider RWD’s role in study programs and regulatory bodies to issue guidance on their use in clinical development.
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A Leading Academic Medical Center Monitors Newly Diagnosed Myeloma Patients
5/20/2022
Learn how eCOA helped to motivate patients and increased engagement around experiences outside of the clinical setting, which otherwise may have gone unmentioned.
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Gradually Investing In Direct Data Capture Is Inevitable
2/2/2023
Given study decentralization and the many electronic sources of data now available, it is time for sponsors and contract research organizations to face the inevitable: EDCs need to be “sunsetted.”
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One Key To Choosing The Best eClinical Technology Vendor
2/29/2024
Explore why the integration of etechnologies is critical in the modernization and optimization of clinical trials, and how the right partner will ensure studies are more efficient, reliable, and inclusive.
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3 Key Functions Your eTMF Needs To Meet New EMA Regulations
6/23/2022
The European Union Clinical Trial Regulation No. 536/2014 recently introduced the most significant changes to the processes for clinical trial applications in at least the past 15 years. Learn how this impacts the Trial Master File and consider three key functions that an electronic TMF must have to achieve compliance and maintain organizational success.
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The Case For Cognitive Assessments In Phase 1 Clinical Trials
7/16/2024
Regulators prioritize patient-reported outcomes. Cognitive assessments in Phase 1 trials detect early drug-related cognitive effects, ensuring safety and efficacy. Signant’s CDR System® is a proven tool for this.
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Want To Make Your Trial More Patient-Centric? Here's An eCOA For That
4/29/2022
Electronic clinical outcome assessments transform the paper-based evaluation into a real-time digital tool that collects insights directly from the patient. Explore how this brings several immediate benefits.