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Life Sciences | News, Analysis, Insights - HIT Consultant

Survey Shows Burdens on Clinical Research Sites Sharply Increasing Since 2018

by Jasmine Pennic 11/06/2023 Leave a Comment

What You Should Know: - Advarra, a prominent player in regulatory review solutions and clinical research technology, has released findings from its 2023 Study Activation Survey. Since 2018, nearly 60% of sites have experienced an increase in study volume. The survey reveals sites are also managing more sponsor-provided technology, which is now perceived as a higher burden than contracting and budgeting. - The 2023 Study Activation Survey aimed to capture the perspectives and experiences from over 500 North American clinical research professionals. The survey rated the impact of processes such as site feasibility, budgeting and contracting, patient recruitment, and subject compensation on study startup, as well as the role of technology and site tools and their benefits and burdens. Key findings from the survey include: - Technology Utilization: More than half of site respondents utilize various technologies such as electronic data capture (EDC), interactive voice response (IVR), and safety letter distribution systems. Between 33-50% of sites are using electronic patient reported outcomes (ePRO), electronic clinical outcomes assessment (eCOA), learning management, document exchange, and site payment systems in over three-quarters of studies. - Technology Impact: Despite advances in clinical trial systems, sites express concerns about technology's impact on their daily workflows. Sponsor technology setup and training during study startup are considered the most burdensome activities. Over half of sites (55%) find setup and training on sponsor technology extremely or very burdensome, with 67% feeling that it's worse than five years ago. - Multiple Logins: As technology usage increases, site staff face a commensurate increase in the number of logins required, with nearly 70% of respondents reporting having six or more logins per study. - Credential Consolidation: To address the complexity of multiple logins, 81% of respondents believe that using their own site credentials to access various systems would be valuable. - Burden in Clinical Trials: Budgeting (41%) and contracting (36%) are rated as the next extremely or very burdensome activities for clinical trials after sponsor technology setup and training. - Contract and Budget Utilization: Only 36% of sites report that sponsors and contract research organizations (CROs) always or often leverage existing contract terms, and budgets are similarly underutilized, with only 31% stating that sponsors and CROs always or often use existing terms. - Value of eReg Binder Technology: 80% of sites find it extremely or very valuable to have their organization's eReg binder technology connected to the sponsor and CRO technology used for document exchange and review in study startup. - Site Engagement Tools: At least 50% of sites find site engagement tools to be very or extremely useful, with the top four tools, including visit essentials, quick links to other study tools, visit calculator, and protocol text search, rated as very or extremely useful by more than 80% of sites. Feasibility Surveys: Nearly half of sites (49%) say the burden of feasibility surveys has increased over the past five years, possibly due to redundant site capability questions. eConsent: Only 14% of sites report that sponsors or CROs consistently offer eConsent for more than 75% of site studies. Reimbursement Requests: Sites frequently request reimbursement for costs associated with remote monitoring, including CRO monitoring visits (71%) and remote monitoring setup (63%). “Sites are increasingly saddled with complex technologies and duplicative, administrative tasks. We need to come together as an industry and support both sites and sponsors with technology that works for each stakeholder respectively and helps improve clinical research – not hinder it,” said Gadi Saarony, CEO of Advarra. “Advarra uniquely knows and understands the needs of sponsors, CROs, sites, and participants and is committed to driving industrywide stakeholder collaboration and to be the pioneer in connecting the clinical research ecosystem.”

What You Should Know: - Advarra, a prominent player in regulatory review solutions and clinical research technology has released findings from its 2023 Study Activation Survey. Since 2018, nearly 60% of clinical research sites have experienced an increase in study volume. The survey reveals sites are also managing more sponsor-provided technology, which is now perceived as a higher burden than contracting and budgeting. - The 2023 Study Activation Survey aimed to capture the perspectives
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Verana Health Partners with Foundation Fighting Blindness to Integrate Genetic Testing Data into Real-world Evidence Research

by Syed Hamza Sohail 11/03/2023 Leave a Comment

Verana Health Partners with Foundation Fighting Blindness to Integrate Genetic Testing Data into Real-world Evidence Research

What You Should Know: Verana Health® (Verana), a digital health company helping to revolutionize patient care and clinical research by unlocking the potential of real-world data, and the Foundation Fighting Blindness – the world’s leading organization committed to finding treatments and cures for blinding retinal diseases—announce a partnership focused on providing the life sciences community with deeper and broader data to optimize and expedite clinical trials.Under the
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SubjectWell Acquires PatientCentra, Expanding Ability to Recruit for Rare Disease/Oncology Indications

by Jasmine Pennic 11/03/2023 Leave a Comment

SubjectWell Acquires PatientCentra, Expanding Ability to Recruit for Rare Disease/Oncology Indications

What You Should Know:  - SubjectWell, a patient access marketplace connecting individuals with chronic health conditions to healthcare options, has acquired PatientCentra, a company specializing in global patient recruitment and personalized recruitment journeys. Financial details of the acquisition were not disclosed.  - This strategic acquisition enhances SubjectWell's capacity to serve patient recruitment needs for international clinical studies and further extends its
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M&A: Viome Acquires Naring Health

by Syed Hamza Sohail 11/02/2023 Leave a Comment

M&A: Viome Acquires Naring Health

What You Should Know: Viome Life Sciences, a longevity company committed to translating scientific advancements into actionable and individualized health solutions, today announced the acquisition of Naring Health, a digital health and wellness company providing access to individualized clinical and molecular data to empower informed decisions.Under Naring Health, Viome will also be acquiring DiscernDX, a company making regular health monitoring, early disease detection, and
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United Therapeutics to Acquire Miromatrix Medical for $91M

by Fred Pennic 10/30/2023 Leave a Comment

United Therapeutics to Acquire Miromatrix Medical for $91M

What You Should Know: - United Therapeutics Corporation and Miromatrix Medical Inc. announced today a definitive agreement for United Therapeutics to acquire Miromatrix for $91M. - The acquisition of Miromatrix will expand United Therapeutics’ existing complementary platform of organ manufacturing programs, which include ex-vivo lung perfusion, xenotransplantation, 3-D bioprinting, and regenerative medicine approaches with the objective of creating an unlimited supply of tolerable,
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3 Ways for Government to Help Spur Biomedical Innovation

by Margaret Anderson, Managing Director at Deloitte Consulting LLP 10/27/2023 Leave a Comment

3 Ways for Government to Help Spur Biomedical Innovation

In response to the COVID-19 pandemic, the biomedical community took on the task of developing and deploying critical interventions to address an unprecedented public health emergency. In a remarkable display of collective effort, stakeholders from government and industry came together to produce safe and effective mRNA vaccines as well as therapeutics– a groundbreaking achievement reached in record time. As the biomedical community looks to the future, government agencies have a tremendous
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Georgiamune and Verily Partner to Advance Novel Cancer Treatment

by Jasmine Pennic 10/26/2023 Leave a Comment

Georgiamune and Verily Partner to Advance Novel Cancer Treatment

What You Should Know: - Georgiamune, a privately held, clinical stage biotechnology company, and Verily, an Alphabet precision health technology company forms a strategic partnership to advance novel therapeutics for patients with cancer. - Through this partnership, Verily and Georgimune will focus on identifying the patient population that could potentially benefit the most from Georgiamune’s GIM-122, a first-in-class dual-functioning antibody that has the potential to help patients with
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M&A: PicnicHealth Acquires Rare Disease Platform AllStripes

by Fred Pennic 10/23/2023 Leave a Comment

M&A: PicnicHealth Acquires Rare Disease Platform AllStripes

What You Should Know:  - Patient-centered health data company PicnicHealth today announced it has acquired AllStripes, a healthcare technology company dedicated to unlocking new treatments for people with rare diseases. Financial terms of the transaction are not disclosed. - Founded in 2017,  AllStripes has developed a technology platform that generates research-ready evidence to accelerate rare disease research and drug development, as well as a patient application that empowers
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Pangea, FibroFighters Partner to Advance Rare Liver Cancer Treatment

by Syed Hamza Sohail 10/23/2023 Leave a Comment

Pangea, FibroFighters Partner to Advance Rare Liver Cancer Treatment

What You Should Know: Pangea Biomed, the startup behind the innovative treatment response predictor, ENLIGHT, today announced its partnership with patient-centric advocacy organization FibroFighters to advance treatment for fibrolamellar carcinoma (FLC) patients.Fibrolamellar carcinoma (FLC) is a rare liver cancer that typically presents in young adolescents and young adults at a median age of 22 who have no history of liver disease. There is no clear standard of care for the disease, and in
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Nucleus RadioPharma Secures $56M to Expand Radiopharmaceutical Treatments for Cancer Patients

by Syed Hamza Sohail 10/23/2023 Leave a Comment

Nucleus RadioPharma Secures $56M to Expand Radiopharmaceutical Treatments for Cancer Patients

What You Should Know: Today,  Nucleus RadioPharma the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals has announced an oversubscribed $56 million Series A funding round led by Eclipse and GE HealthCare with participation from Echo Global, Fox Chase Cancer Center, Granger Management, Mayo Clinic, Mercy Health, and University of Missouri.With this round of funding,
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