• New Award at SCOPE Honors Innovation In Clinical Trial Site Success

    Clinical Research News | The SCOPE team just announced the finalists in the inaugural Site Innovation Award, recognizing sites and partnerships pioneering new approaches to improve clinical trials. The winner will be announced at the Summit for Clinical Ops Executives in Orlando, February 11-14, 2024.

    Dec 19, 2023

  • Planning for a Successful EMA Policy 0070 Submission

    Clinical Research News | European Medicines Agency (EMA) Policy 0070 requires the proactive publishing of clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralized procedure. In other words, the EMA will publish anonymized documentation (with sensitive participant and company data protected) supporting the use of a drug on its public Clinical Data website so that anyone can read about medicines being authorized.

    Dec 15, 2023

  • Pharma’s Tech Partner Wish List

    Clinical Research News | What is pharma looking for in technology partners? That was the question posed to a panel representing Pfizer, Johnson & Johnson, GlaxoSmithKline, and AstraZeneca last month at the HLTH Conference. The answers revealed some of the trends these pharma companies expect to see in drug development and clinical trials, and the pain points they are actively addressing now.

    Dec 14, 2023

  • Participant Engagement Award Finalists Named for 2024

    Clinical Research News | The judges have announced the finalists for the annual Participant Engagement Award that is awarded each year at SCOPE, the Summit for Clinical Ops Executives. In 2024, entries from Acclinate, CISCRP, IMA Clinical Research, Oliver Patch Project, PatientWing, and SGM Alliance have progressed to the final round of consideration. The winner will be named after a live judging session with audience participation in Orlando, February 11-14.

    Dec 12, 2023

  • Navigating Cell Therapy Clinical Trial Budgets: Proactive Strategies for Success

    Clinical Research News | Clinical trial sponsors must strike a balance between budget, speed, and data quality when planning for cell therapy clinical trial costs. These costs can be difficult to predict and budget overruns often happen. However, cell therapy sponsors can better plan for clinical trial costs and lower their risk of exceeding their budgets by taking specific steps early on.

    Dec 8, 2023

  • Colleen Tenan on Respect and Mindfulness During Patient Treatment

    Clinical Research News | Clinical trials can lead to breakthroughs in research, but they can also be a viable and beneficial care option for patients. According to Colleen Purcell Tenan, M.D., medical director at Javara, clinical trials can offer resources that many patients do not have access to, such as medications not covered by insurance, counseling, and close medical follow-up.

    Dec 7, 2023

  • Prevention Strategy For Alzheimer’s Disease Now On The Horizon

    Clinical Research News | It may be possible one day soon to prevent Alzheimer’s disease, a devastating illness currently suffered by more than 30 million people worldwide. The good news comes straight from the mouth of Randall J. Bateman, M.D., professor of neurology at Washington University School of Medicine and director of the Dominantly Inherited Alzheimer Network (DIAN) and DIAN Trials Unit (DIAN-TU).

    Dec 6, 2023

  • Follow the Money: Regenerative Medicine, Oral Delivery, Therapeutics, DNA Platform for Rheumatoid Arthritis, Cancer Therapy Research

    Clinical Research News | Imagine Pharma plans to advance the company’s priority programs in regenerative medicine, oral delivery, and therapeutics; Aqtual will expand its platform that evaluates protein regulation, epigenetics, and transcriptomics; the Department of Immunology and Immunotherapy and the Icahn Genomics Institute at the Icahn School of Medicine at Mount Sinai have been awarded a grant to advance cancer therapy research; more.

    Nov 30, 2023

  • Greenphire, Florence Healthcare Partnership; Oxford Nanopore Collaborations To Develop Data Tech; University Of Texas Launches Oncology Institute

    Clinical Research News | Greenphire and Florence Healthcare teams up to integrate their software solutions to help sites get paid quicker; Oxford Nanopore Technologies collaborates with Fabric Genomics and Sapehtor to develop data technology; The University of Texas MD Anderson Cancer Center launches its Institute for Data Science in Oncology (IDSO) to help improve patients’ lives by transforming cancer care and research; more.

    Nov 29, 2023

  • SCOPE 2024 To Feature First-Ever Start Up Pitch Competition

    Clinical Research News | The first-ever Clinical Trial Tech: Start Up Pitch Contest will be held on Feb. 12, 2024, in conjunction with the annual Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. Emerging clinical trial companies with less than $10 million in funding and a groundbreaking product are invited to apply for further investment by Dec. 15.

    Nov 28, 2023

  • The Importance of Diversity in Clinical Trials: A Comprehensive Analysis

    Clinical Research News | Clinical trials are pivotal in propelling medical research forward and enhancing the quality of patient care. Yet, for an extended period, a conspicuous absence of diversity within clinical trial participants has been observed, leading to the underrepresentation of specific demographics and the possible emergence of healthcare disparities.

    Nov 21, 2023

  • Osteoarthitis: It’s Time to Spark Regeneration Innovation

    Clinical Research News | Organ regeneration is not a new idea. After creating humans and giving us knowledge, Prometheus was doomed to regenerate his own liver every day to feed Zeus’ pernicious eagle. Osteoarthritis (OA) predates Prometheus; paleontologists have dug up dinosaurs with bad hips.

    Nov 17, 2023

  • Action Plan Developed To Enhance Enrollment In Acute Stroke Trials

    Clinical Research News | Time is of the essence when it comes to acute stroke trials, where investigators may have mere minutes to obtain consent—in many cases, from a loved one of the patient. Because consenting delays can impact the potential efficacy of an experimental treatment, they represent the biggest obstacle to both participant enrollment and scientific advancement in the field.

    Nov 14, 2023

  • EU Clinical Trial Regulation 536/2014: Real-World Learnings, Best Practices For Successful Document Submissions In An Evolving System

    Clinical Research News | The European Union Clinical Trial Regulation 536/2014 went live on January 31, 2022, with the purpose of harmonizing clinical trial document submission processes within the European Union member states and improving transparency to the public.

    Nov 10, 2023

  • Seeing the Bigger Picture for AI Application With Michael Ibara

    Clinical Research News | Though increasing in popularity, the application of AI is not as widespread as some may think. In the case of clinical trials, AI is seldom used to help with organizing data, managing studies, and processing information.

    Nov 8, 2023

  • Innovation Opportunities in Vendor Selection and Partnerships

    Clinical Research News | In clinical research, outsourcing is more of a partnership than it is just handing off work to other teams. The stakes are high, and the success of outsourcing relationships directly impact the success or failure of a pharmaceutical program.

    Nov 7, 2023

  • Decentralized Clinical Trials: Navigating The Regulatory Landscape For Efficient And Patient-Centric Research

    Clinical Research News | The global decentralized clinical trials (DCTs) market is expected to see significant growth in the coming years. In 2021, the market was valued at $8.8 billion. And in 2026, the market is projected to reach $14.2 billion. Several key factors are fueling this transformation, including the impact of COVID-19 lockdowns and restrictions, the increasing demand for faster and more cost-effective drug trials, the growing preference of patients to participate in clinical trials remotely, and the availability of electronic patient-reported outcomes (ePRO).

    Nov 3, 2023

  • Evaluating Risk in the Era of Decentralized Clinical Trials

    Clinical Research News | Since the pandemic, decentralized trials have claimed the lion’s share of conversation around trial design and participant engagement. When it comes to risk-based quality management, decentralized trials can also mean decentralized control. More options for patients means more opportunity for risk.

    Nov 1, 2023

  • Sexy Science, Clinical Ops as a Business, Data Custodians

    Clinical Research News | Bravard’s opening keynote at SCOPE Europe challenged the community to view clinical ops as a growth driver for business and inspired them to fight the good fight.

    Oct 31, 2023

  • Mayo Clinic And Oxford Nanopore Team Up, Walgreens Collaboration For Heart Disease Clinical Trial, Qnovia Partners With University Of Virginia

    Clinical Research News | Mayo Clinic and Oxford Nanopore Technologies unveils a multi-year joint development collaboration to develop new clinical tests for diseases and improve patient care; Walgreens and the Cardiovascular Research Foundation (CRF) announces a collaboration to drive forward the PREVUE-VALVE study, a population-based clinical trial to quantify the prevalence of valvular heart disease (VHD) among older Americans; Qnovia enters a drug development collaboration with the University of Virginia (UVA) to advance novel inhaled-drug candidates for treating bacterial infections in the lungs; and more.

    Oct 26, 2023