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News and Blogs

Blog: The proactive benefits of compliance with ICH E6 (R3)


New regulatory guidance will have a profound impact on all organizations engaged in clinical trials, encouraging the use of modern business methods and technologies.

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Blog: How #NoGoingBack might apply to Pharmacovigilance


There is a need to scale systems, human processes, and signal detection efforts, as companies have to sort through an ever-growing volume of data and data sources on adverse events.

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Blog: The foundation of the clinical trial story starts with study startup


Over half of all TMF artifacts are associated to milestones prior to site activation, underscoring the significance of these preliminary activities prior to the study enrolling patients.

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Article: Starting studies right can ensure a stronger finish


A leader from the clinical trial technology firm suggests ways to design research from the start to help accelerate studies and avoid stumbling blocks.

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Article: Addressing Roadblocks in Decentralized Trials


In a virtual roundtable discussion, industry experts Jim Streeter, Alison Holland, Hassan Kadhim, Craig Lipset, Josh Rose, and Craig Serra share their insight on the challenges faced in implementing decentralized trials and how to address them.

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Blog: Connecting the clinical research ecosystem


Integration shouldn't be an afterthought when it comes to "knitting" together systems used to run a clinical trial.

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Article: How Machine Learning Will Eliminate Failures In Clinical Trials


There are challenges that need to be overcome, but the future of clinical trials is bright and will only get better with the use of AI and machine learning.

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Article: The future of clinical trials: Are DCTs fast becoming the new norm?


As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.

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Blog: How can the accelerated availability of Pfizer-BioNTech’s COVID-19 vaccine be replicated?


Pfizer successfully brought a highly effective and safe vaccine to market in under a year. How was this achievable? And can these same breakthroughs be applied to other studies?

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Blog: Embracing telemedicine now and in the future


How is telemedicine being using in medicine and clinical research today, and will it still be widely used after the pandemic ends?

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Blog: Making the match: how a patient-first strategy can benefit clinical trials


Exploring the range of options available form clinical trial matching services and the role data plays by putting patients at the center of the search process.

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Blog: Parallelization: imperative to the compression of clinical trial cycle times


Compressing schedules using parallelization represents the greatest opportunity to realize efficiency gains that are reproducible across all studies, and just on an as-needed basis.

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Article: COVID-19 forever changed clinical trials and the search for new drugs. Now, there’s no going back


Oracle’s Henry McNamara on the life sciences industry’s COVID-19 victories and the challenges ahead.

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Article: Parallelization: Imperative To The Compression Of Clinical Trial Cycle Times


Clinical trials are the quintessential project, being both complex and requiring project management skills and techniques to bring them to a successful close.

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Blog: How to build productive, strategic sponsor-CRO partnerships


Making sponsor-CRO partnerships as productive as possible means continuing the transition away from tactical projects toward strategic partnerships with both stakeholders having a vested interest in greater operational efficiency.

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Blog: Four ways concomitant medications can complicate your clinical trial


Concomitant medications can have a serious impact on the length and cost of a clinical trial. Con-meds impact patient eligibility, safety, and outcomes.

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Article: Top 5 Challenges of Decentralized Clinical Trials and How To Overcome Them


As COVID-19 began to spread around the world, life sciences organizations conducting clinical trials had to quickly adopt remote data collection technologies and processes to keep patients safe and clinical trials running.

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Blog: Are you prepared for regional, post-market medical device safety regulations?


The rapid reporting of adverse events, incidents, and malfunctions associated with medical devices to the health authorities is paramount, spearheading a trend towards the electronic reporting of high-quality post-market safety data.

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Article: Regenerative medicine is already changing the way drugs are discovered and tested


Regenerative medicine might someday provide replacement organs for transplant patients. But Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, explained how the technology is already helping in the discovery and testing of drugs.

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Article: Industry View: Henry McNamara, Oracle Health Sciences


Henry McNamara, Senior Vice President and General Manager, Oracle Health Sciences, reviews the lessons that the industry has learned over the last year and looks at what lies ahead for pharma in 2021.

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Blog: Say goodbye to trial bottlenecks with automated SOPs


Bottlenecks can have punishing consequences on clinical trials and operational teams, forcing studies to get stuck in limbo when the delay lingers.

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Article: Saama, Oracle partner on integrated clinical trial technology


Saama’s range of Smart applications will be integrated with the Oracle Health Sciences Clinical One platform to help users accelerate drug development.

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Blog: How to realize the efficiency benefits of ICH E6 (R3) before it's released


Learn how applying critical thinking, a key element of the new ICH E6 (R3) regulations, during study startup is pivotal to improving study conduct overall.

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Article: The Future of Decentralized Trials


For the past few years, sponsors and CROs have moved steadily towards decentralized clinical trials. These shifts apply new approaches and technologies to clinical trials with the goal of reducing or eliminating the need for subjects to physically visit clinical research sites.

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Article: The Road to True Data Harmonization


eClinical, eSource, and EHRs is the journey to the holy grail of data efficiency in clinical trials.

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Blog: 10 reasons to avoid using Excel for clinical trials


The instinct to turn to Excel for analytical tasks is undeniable given its ubiquity, but is Excel the right tool to use for planning and collection of clinical data?

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Article: Saama Technologies and Oracle partner to expedite clinical trials


Saama Technologies has partnered with Oracle to offer life sciences industry artificial intelligence (AI) enabled applications to accelerate clinical trials.

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Article: Industry Using AI/ML to Improve Data, Quality, and Trial Management, Survey Says


Data, quality, and trial management top the list of ways the industry is using artificial intelligence (AI) and machine learning (ML), according to a new survey of the technologies’ impact on clinical trials.

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Blog: How one nurse is using her own COVID-19 experience to advance clinical research


Katie Klatt is a recovered COVID-19 patient and a participant in a COVID-19 antibody clinical study. This is her story.

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Blog: Innovation through integration: increase speed without compromising quality


Learn how the integration of "best-of-breed" products designed to unify data can overcome the legacy hurdles of clinical development.

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Blog: Excel – if all you have is a hammer, everything looks like a nail


Excel might be the most dangerous software on the planet, and its failings continue to grab headlines.

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Blog: Data challenges in decentralized clinical trials


Decentralized trials presents a challenge for clinical teams in regard to capturing, managing, and analyzing data from new sources, and in new forms.

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Article: Why back-office systems are more critical to healthcare providers today than ever before


While healthcare providers have invested heavily in clinical systems over the past decade, they’ve mostly ignored financial and operational systems.

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Article: Do Sponsors Have the Data Required for A Successful AI Implementation?


Hear industry experts discuss the data required for a successful AI implementation and where companies will get that data.

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Article: Current Health launches decentralized clinical trial initiative


Community by Current Health is now enrolling participants in a COVID-19 study that uses its FDA-cleared remote monitoring system.

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Blog: Why back-office systems are more critical to healthcare providers today than ever before


The financial plight of healthcare providers amid the COVID-19 pandemic makes it more imperative than ever for HCPs to modernize their back-office systems.

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Article: Oracle foresees speedier trials with Cognizant tie-up


Oracle is teaming up with digital life sciences firm Cognizant to hasten trial starts.

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Blog: How machine learning can help improve the operational efficiency of clinical trials


Learn how innovative machine learning techniques are showing great promise in helping life science companies identify and rectify systemic inefficiencies.

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Blog: Reining in the CRO oversight quagmire


By transitioning to a solution used by all CROs across the portfolio, oversight improves, and sponsors can build reliable institutional knowledge about CRO performance.

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Article: Oracle, Cognizant alliance aims to accelerate study startups


Oracle and Cognizant are integrating technologies in a move designed to help hasten trial launches, and get promising new treatments to market faster.

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Article: Breaking down the barriers to decentralized trials


Q&A with Oracle Health Sciences’ GM Henry McNamara on the recent Oracle-Informa research and how COVID-19 has impacted how the industry views decentralized clinical trials.

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Blog: Joining the #NoGoingBack movement


The pandemic has created a lot of disruption in clinical trials, but not all of it has been negative.

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Blog: Squaring regulatory issues in decentralized clinical trials


Existing regulations remain in place that can make it difficult to actually design and run a decentralized clinical trial.

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Blog: Use AI to minimize viral outbreaks and enhance treatments


The application of AI to disease management and treatment is rapidly evolving and providing itself invaluable, one therapeutic area that has quickly demonstrated benefits from the application is infectious disease.

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Blog: The treacherous study startup journey


As the industry focuses their efforts to improve study startup, stakeholders are reaching out to providers well-versed in the intricacies of study startup, who have a proven track record.

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Blog: Reducing complexity in starting clinical trials - more patients, faster startup


Learn about the collaboration between Cognizant and Oracle that eliminates redundancy for sites and delivers better outcomes for sponsors and CROs.

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Blog: Miniaturized organs are joining the fight against COVID-19, cancer


"Body-on-a-chip" innovation will make clinical trials faster, safer.

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Article: Trendspotting: Decentralized Trials, AI, Real-World Data in 2021


Leaders in clinical research are working hard to synthesize what 2020 brought us and apply learnings to 2021.

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Article: Pandemic Accelerates The Evolution Of Clinical Trials


How much has the COVID-19 pandemic accelerated the evolution of clinical trials? A new report from Oracle Health Sciences and Informa Pharma Intelligence attempts to answer that question.

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Blog: From ‘System Sprawl’ to ‘Light Speed’ – Transforming Trial Technology


Sponsors and trial designers can be vexed when it comes to using existing tools to manage data from a growing number of sources, along with the “system sprawl” that forces users to master multiple applications and manage integrations among those applications.

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Article: Oracle Health Sciences 2021 Industry Predictions


This industry won't be going back to “the old way.” Oracle GM and SVP, Henry McNamara, makes predictions for sponsors and CROs in 2021.

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Blog: Spreading Joy to Those in Need – The Role of Therapy Dogs in a Clinical Setting


There’s a reason that you may have seen a dog roaming the halls of your local hospital. Research shows that animals can improve the mental, physical, and emotional wellbeing of their human companions.

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Blog: The Big Picture


Final recommendations on your UX study allow your stakeholders to quickly understand the big takeaway from this project, and take the appropriate actions in response to those findings.

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Blog: Zoinks! What does it all Mean?


How do you communicate your findings from a UX study so that your stakeholders can actually understand them the way you do, and use them to improve the user experience?

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Blog: Oracle Requests your Participation in Survey on Machine Learning


How are organizations approaching the adoption of machine learning capabilities to the planning and execution of clinical trials?

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Blog: U-Turn or Norm? #NoGoingBack and Decentralized Trials in a post-COVID-19 World


Stakeholders have been very vocal – there is no turning back – cumulating in the #NoGoingBack movement, arguing that the pace of innovation adoption must continue in a post-COVID-19 world.

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Article: COVID-19 Fueling Decentralized Trial Surge: Oracle Survey


A recent survey conducted by Oracle reveals trial professionals’ thoughts, feelings and behavior around decentralized research in the face of the pandemic.

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Blog: Decentralized Trials — Changing Clinical Research Forever


The concept of decentralized trials with “hybrid” (in-person and remote patient visits) or fully-remote subject visits has just been catapulted beyond small satellite innovation teams to becoming the new norm.

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Blog: Cloud and AI in Safety Management: A Conversation with ICON


ICON discusses the efficiencies gained moving their safety case management to the cloud while maintaining quality and accuracy.

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Press Release: Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials


76% of industry respondents are now running some decentralized trials, but cite concerns with data collection and quality.

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Blog: Operating in a Whole New (Data Collection) World


With Oracle’s Clinical One, the problems that were a nightmare in the making are now a thing of the past. With its sleek adaptive trial design, this truly unified platform is a great fit for Health Decisions.

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Blog: Earlier Strategic Planning Key to Clinical Trial Recruitment


Many facets of a clinical trial are unpredictable. This is why scenario planning is so valuable, and critical to helping to manage the variability in clinical trial setup decisions.

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Blog: Vendor Oversight: Ensuring Regulatory Compliance by Assessing Study Risks


ICH E6 (R2) introduces the concepts of vendor oversight and risk management, but have these requirements been implemented jointly or as separate initiative’s today?

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Blog: Let the Discovery Begin!


After recruiting participants for usability testing it's on to discovery, setting up the environment which mirrors what participants see every day and observing them as they navigate a series of tasks to be performed.

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Blog: The Silver Lining from COVID-19 for Clinical Trials


The COVID-19 pandemic has changed so many things about our personal and work lives that have us anxious to get back to normal. The pandemic has also led to some significant changes in clinical trials.

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Blog: Using Machine Learning to Mitigate Failures and Reduce Costs in Clinical Operations


Discover how machine learning provides critical operational insights, allowing organizations to learn and adapt.

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Blog: The Prix Galien — Honoring Pharmaceutical Research and Development for 50 Years


Every year, the brightest minds in pharmaceuticals and clinical innovation put on their best black-tie attire for the life science industry’s biggest event – the Prix Galien.

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Article: FHI Clinical, Oracle Partner on Cloud-Based Trial Tech


The CRO and life sciences tech firm collaborated on a solution capable of meeting challenges tied to starting and conducting global clinical trials.

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Blog: Embracing the Future of Decentralized Trials and Remote Visits for Site Staff and Patients


How have current trends like patient-centric trials been empowering the site landscape, and how has the pandemic helped shape the future of how patient-facing devices are used?

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Blog: Keeping Pace with Data Collection in Clinical Trials


As patient-worn sensors and IoT put more data at the fingertips of investigators, managing that data requires a shift to more modern technology solutions.

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Blog: Is Artificial Intelligence Critical to Improving Efficiencies and Outcomes in Clinical Trials?


Machine learning technologies can help predict outcomes in clinical trials, leading to faster drug approval times, lower costs, and more funding to develop new treatments.

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Press Release: FHI Clinical and Oracle Bring Critical Clinical Trial Capabilities to Markets in Need


Study sponsors and global health organizations can take advantage of Oracle Health Sciences Clinical One cloud platform to improve clinical trial efficiency.

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Blog: Study Startup Expertise Supports our Global Customers Impacted by COVID-19


For the thousands of active clinical trials, mitigation plans were set. Clinical development teams needed to assess which trials would need to be delayed, others completely stopped, some prematurely ended.

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Press Release: Oracle Health Sciences Positioned as a Leader in Everest Group’s PEAK Matrix® for Clinical Development Platforms


For the fourth straight year, Oracle Health Sciences has been named a “Leader” in the Everest Group Clinical Development Platforms Products PEAK Matrix® Assessment 2020. Oracle Health Sciences maintained its position as the highest positioned vendor in “Vision and Capability” and took the highest position for “Market Impact.”

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Blog: How to Implement Operational Predictions and Why These Insights are Key to Business Success


Machine learning allows organizations to continuously improve with direct implications on timelines and associated costs of clinical trials.

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Blog: COVID-19’s Impact on the Digital Transformation of Clinical Trials


The immediate impact of COVID-19 on clinical trials is now being overshadowed by the opportunities it presents to reimagine and reinvigorate studies.

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Blog: Automating Safety Case Processing: The Touchless Future


As the capabilities of various systems improve over time, more widespread use of touchless processing will become feasible. Given that likely future, companies can begin now to plan for and lay the groundwork for a touchless case processing system.

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Blog: Q&A Follow-Up to Inaugural CRO Roundtable


Due to an overwhelming response: Q&A follow-up to the inaugural CRO Roundtable.

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Blog: QbD: Should Operational Audit Readiness be Defined as ACA+C?


Fundamental to ICH guidelines is the modernization of processes and technology to clinical trials with a focus on Quality by Design and risk-based management approaches.

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Blog: Automating Safety Case Processing: AI as Game Changer


While simpler automation processes are able to replace routine or static human activity, AI systems are capable of analyzing data and applying specialized knowledge to the safety case process.

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