The Signal Expert insights and opinions on clinical research and drug development. Expert insights and opinions on clinical research and drug development. EMA Draft Guidance: Here’s What It Tells Us About BYOD August 31, 2021 Bill Byrom Posted in eCOA The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on… Read More Direct-to-Patient Clinical Supply Distribution: Everything You Need to Know August 27, 2021 Signant Health Posted in Clinical Supplies The adoption of decentralized studies has rapidly increased thanks in part to the recent pandemic, which encouraged regulators to permit more flexibility within protocols and forced sponsors to implement… Read More The Inaugural IMAGINE FORUM Recap August 25, 2021 Signant Health Posted in Telemedicine & Virtual Monitoring At Signant Health, we believe progress is best done together. That’s why we launched the Imagine Forum to promote industry-wide collaboration and thoughtful discussion. … Read More AAIC 2021 Recap August 24, 2021 Signant Health Posted in Scientific Advisory Here are a few takeaways from Signant’s presentations that you may have missed: Dr. Miller led a product showcase, Glimmers… Read More Key Technology Elements for Successful Hybrid Trials August 20, 2021 Bill Byrom Posted in eCOA As the industry continues to predict and debate what the “new normal” in clinical development will look like in an… Read More Mixing eCOA Modes: How to Respond Post-COVID Mitigation August 16, 2021 Bill Byrom Posted in eCOA Over the early months of the pandemic, we worked with clients to implement mitigations for studies that continued but were… Read More Best Practices: RTSM Strategies to Avoid Partially Unblinding Clinical Trials August 9, 2021 Signant Health Posted in Clinical Supplies Randomization and Trial Supply Management (RTSM) solutions are routinely used in today’s clinical trials to manage randomization, enable emergency code break to… Read More Analytics Approaches to Assessing Clinical Endpoint Data Consistency July 27, 2021 Alan Kott Posted in Data Analytics Clinical research sponsors collect more data on more endpoints than ever before, especially since the proliferation of remote/decentralized clinical trials. From… Read More Preparing Study Staff, Sites, and Patients for Remote Video Assessments and Consultations July 13, 2021 Signant Health Posted in Scientific Advisory With the proliferation and widespread acceptance of telemedicine solutions in clinical research, it is imperative to properly prepare everyone involved in a study to… Read More Clinical Research Technology Comparison: Telemedicine Versus Video Conferencing for Healthcare July 9, 2021 Daniel Bouganim Posted in Telemedicine & Virtual Monitoring Telemedicine or telehealth solutions may not be new, but virtual video visits are becoming more common for communication between patients and healthcare providers thanks to COVID-19. In clinical trials, the application of telemedicine technology is still evolving. Clinical trials have far… Read More Previous 1 2 3 4 Next
EMA Draft Guidance: Here’s What It Tells Us About BYOD August 31, 2021 Bill Byrom Posted in eCOA The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on… Read More Direct-to-Patient Clinical Supply Distribution: Everything You Need to Know August 27, 2021 Signant Health Posted in Clinical Supplies The adoption of decentralized studies has rapidly increased thanks in part to the recent pandemic, which encouraged regulators to permit more flexibility within protocols and forced sponsors to implement… Read More The Inaugural IMAGINE FORUM Recap August 25, 2021 Signant Health Posted in Telemedicine & Virtual Monitoring At Signant Health, we believe progress is best done together. That’s why we launched the Imagine Forum to promote industry-wide collaboration and thoughtful discussion. … Read More AAIC 2021 Recap August 24, 2021 Signant Health Posted in Scientific Advisory Here are a few takeaways from Signant’s presentations that you may have missed: Dr. Miller led a product showcase, Glimmers… Read More Key Technology Elements for Successful Hybrid Trials August 20, 2021 Bill Byrom Posted in eCOA As the industry continues to predict and debate what the “new normal” in clinical development will look like in an… Read More Mixing eCOA Modes: How to Respond Post-COVID Mitigation August 16, 2021 Bill Byrom Posted in eCOA Over the early months of the pandemic, we worked with clients to implement mitigations for studies that continued but were… Read More Best Practices: RTSM Strategies to Avoid Partially Unblinding Clinical Trials August 9, 2021 Signant Health Posted in Clinical Supplies Randomization and Trial Supply Management (RTSM) solutions are routinely used in today’s clinical trials to manage randomization, enable emergency code break to… Read More Analytics Approaches to Assessing Clinical Endpoint Data Consistency July 27, 2021 Alan Kott Posted in Data Analytics Clinical research sponsors collect more data on more endpoints than ever before, especially since the proliferation of remote/decentralized clinical trials. From… Read More Preparing Study Staff, Sites, and Patients for Remote Video Assessments and Consultations July 13, 2021 Signant Health Posted in Scientific Advisory With the proliferation and widespread acceptance of telemedicine solutions in clinical research, it is imperative to properly prepare everyone involved in a study to… Read More Clinical Research Technology Comparison: Telemedicine Versus Video Conferencing for Healthcare July 9, 2021 Daniel Bouganim Posted in Telemedicine & Virtual Monitoring Telemedicine or telehealth solutions may not be new, but virtual video visits are becoming more common for communication between patients and healthcare providers thanks to COVID-19. In clinical trials, the application of telemedicine technology is still evolving. Clinical trials have far… Read More Previous 1 2 3 4 Next