The Signal Expert insights and opinions on clinical research and drug development. Expert insights and opinions on clinical research and drug development. Category: eCOA 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better insight into the patients’ disease-related symptoms, side effects of treatment, and effect… Read More EMA Draft Guidance: Here’s What It Tells Us About BYOD August 31, 2021 Bill Byrom Posted in eCOA The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on… Read More AAIC Post Event Blog 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 Five Considerations for BYOD Studies June 20, 2021 Bill Byrom Posted in eCOA In our drive to make trial participation simpler, a bring-your-own-device (BYOD) model is thought to be a convenient approach for trial participants to complete patient-reported outcome… Read More Signant Health Raises the Bar in Ulcerative Colitis Trials with eCOA August 6, 2020 Katie Garner Posted in eCOA The Mayo Clinic Score (MCS) is one of the most commonly used measures of disease activity in clinical trials for… Read More
Category: eCOA 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better insight into the patients’ disease-related symptoms, side effects of treatment, and effect… Read More EMA Draft Guidance: Here’s What It Tells Us About BYOD August 31, 2021 Bill Byrom Posted in eCOA The European Medicines Agency (EMA) draft guidance released this past June on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 AAIC Post Event Blog 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 Five Considerations for BYOD Studies June 20, 2021 Bill Byrom Posted in eCOA In our drive to make trial participation simpler, a bring-your-own-device (BYOD) model is thought to be a convenient approach for trial participants to complete patient-reported outcome… Read More Signant Health Raises the Bar in Ulcerative Colitis Trials with eCOA August 6, 2020 Katie Garner Posted in eCOA The Mayo Clinic Score (MCS) is one of the most commonly used measures of disease activity in clinical trials for… Read More