The Signal Expert insights and opinions on clinical research and drug development. Expert insights and opinions on clinical research and drug development. What are the best practices for handling changes to ePRO data? October 12, 2021 Bill Byrom Posted in eCOA The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective… Read More Get to Know the SME: Todd Feaster, PsyD. October 11, 2021 Signant Health Posted in Scientific Advisory In the first of this new series of Q&A interviews with Signant’s subject matter experts, we sat down with Todd… Read More 2021 SCRS Global Site Solutions Summit Recap October 5, 2021 Signant Health Posted in Events This past week, Signant Health’s Chief Marketing Officer, Scott Connor, and Chief Operating Officer, Jason Martin, participated as panelists at… Read More ISCTM Autumn Conference 2021: Poster Presentations Roundup October 5, 2021 Signant Health Posted in Events The International Society for CNS Clinical Trials and Methods (ISCTM) hosted its 2021 Autumn Conference from Sept 30 – October… Read More eCOA Best Practices: Ensuring Timely Delivery of Translations October 4, 2021 Signant Health Posted in eCOA With more than half of all registered studies occurring in locations outside of the U.S. and the continued upward trajectory… Read More Selecting a Fit-For-Purpose Device September 28, 2021 Bill Byrom Posted in eCOA In today’s protocols, we continue to see an increased appetite to study clinical endpoints derived from wearables and sensors (i.e.,… Read More eConsent Task Force Co-Chaired by Signant and Medidata Honored as Finalists for TOPRA Innovation Award September 16, 2021 Signant Health Posted in eConsent In 2019, a team of industry experts formed a task force to examine challenges and opportunities in the adoption of… Read More 3 Reasons Oncology Studies Should Consider a Pre-Configured eCOA Solution September 2, 2021 Signant Health Posted in eCOA The FDA’s recent guidance placed an increased emphasis on patient-reported outcome measures (PROMs) for oncology trials. This data provides better insight into the patients’ disease-related symptoms, side effects of treatment, and effect… Read More EMA Draft Guidance: Here’s What It Tells Us About BYOD August 31, 2021 Bill Byrom Posted in eCOA The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on… Read More Direct-to-Patient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 Previous 1 2 3 4 5 Next
What are the best practices for handling changes to ePRO data? October 12, 2021 Bill Byrom Posted in eCOA The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective… Read More Get to Know the SME: Todd Feaster, PsyD. October 11, 2021 Signant Health Posted in Scientific Advisory In the first of this new series of Q&A interviews with Signant’s subject matter experts, we sat down with Todd… Read More 2021 SCRS Global Site Solutions Summit Recap October 5, 2021 Signant Health Posted in Events This past week, Signant Health’s Chief Marketing Officer, Scott Connor, and Chief Operating Officer, Jason Martin, participated as panelists at… Read More ISCTM Autumn Conference 2021: Poster Presentations Roundup October 5, 2021 Signant Health Posted in Events The International Society for CNS Clinical Trials and Methods (ISCTM) hosted its 2021 Autumn Conference from Sept 30 – October… Read More eCOA Best Practices: Ensuring Timely Delivery of Translations October 4, 2021 Signant Health Posted in eCOA With more than half of all registered studies occurring in locations outside of the U.S. and the continued upward trajectory… Read More Selecting a Fit-For-Purpose Device September 28, 2021 Bill Byrom Posted in eCOA In today’s protocols, we continue to see an increased appetite to study clinical endpoints derived from wearables and sensors (i.e.,… Read More eConsent Task Force Co-Chaired by Signant and Medidata Honored as Finalists for TOPRA Innovation Award September 16, 2021 Signant Health Posted in eConsent In 2019, a team of industry experts formed a task force to examine challenges and opportunities in the adoption of… Read More 3 Reasons Oncology Studies Should Consider a Pre-Configured eCOA Solution September 2, 2021 Signant Health Posted in eCOA The FDA’s recent guidance placed an increased emphasis on patient-reported outcome measures (PROMs) for oncology trials. This data provides better insight into the patients’ disease-related symptoms, side effects of treatment, and effect… Read More 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 Previous 1 2 3 4 5 Next