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Concerned about the ability of its technology tools to keep pace with changing study startup needs, Clinipace adopted Oracle Activate. As a result, they now have a customized tool that meets the company’s multi-national needs, a more streamlined startup process, and significantly improved data reporting to sponsors.
Read the blogOracle recently participated in the launch of the Digital Medicine Society (DiMe) Sensor Data Integration Tour of Duty. The new cross-industry group was formed to ensure sensor data fulfills its promise to improve patient lives.
Read the blogToday, study startup functions and job roles are more commonplace at sponsor and CRO organizations, but despite this clinical operations teams are drowning in data but starving for information, at a time of intense pressure to speed up clinical trials and restrain costs.
Read the blogRevisions for the ICH E6 (R3) revision are fast approaching, and these guidance’s reconfirm the importance of strategic alignment of eClinical technologies, which ultimately will result in more cost-effective treatment options for patients.
Read the articleThe diversity and volume of data in clinical trials has outpaced the ability of traditional data management approaches utilized at life science organizations. Companies that want to stay ahead of this torrent of data – and derive valuable insights from it – need to adopt a new approach to data management.
Read the blogICH E6 (R3) is coming at a time when life science organizations are still struggling to adopt ICH E6 (R2). There’s no question that ICH E6 (R3) will impact all organizations engaged in clinical trials.
Read the articleTrial methods adopted during the pandemic yield timely, high-quality, and useable data, industry says, but sponsors also have concerns about how these approaches add complexities for sites and investigators.
Read the articleThe stage is set for sponsors and CROs who are able to accelerate their digital transformation roadmaps and embrace innovative approaches to overcome adversaries and reap significant benefits now—and in the future.
Read the blogMen around the world are facing a health crisis that isn’t being talked about, and it’s time to speak up.
Read the blogThe methods utilized during the pandemic are likely to have a lasting impact on the future of clinical trials, according to a new research study conducted by Informa Pharma Intelligence and Oracle.
Read the blogCOVID-19 physical distancing requirements forced change in how traditional clinical trials were conducted; a new Informa Pharma and Oracle study shows the industry is not looking back.
Read the articleOracle survey shows 97% of pharma professionals will continue newly adopted clinical trial approaches as the industry evolves.
Read the press releaseThe way clinical trials are conducted in the European Union (EU) will undergo a major change when (EU) No 536/2014 comes into effect in January 2022. This new regulation is binding across all member states.
Read the blogWith high-performance computing and data science capabilities, the cloud can accelerate clinical research and development, getting new drugs and treatments to the market faster.
Read the blogWith patients at the center of clinical trials, it only makes sense that they can (and should) be involved throughout the drug development process.
Read the blogBy following and supporting the FAIR principles in clinical trials, Oracle can help the industry innovate for continuous improvement in quality, efficiency and collaboration.
Read the blogFor sponsors, improving oversight of study startup means real-time visibility into the progress of studies outsourced to their CRO partners, and transitioning away from tactical projects toward strategic partnerships, with both stakeholders having a vested interest.
Read the blogThe opportunities espoused by the DDF initiative to rethink clinical trials to improve efficiencies and ensure quality, namely providing a single source of truth, upfront planning to ensure downstream quality, parallelization, and machine learning are core unique tenets of the unified Clinical One platform.
Read the blogAs CROs fight to maintain market share and ensure long-term survival, those companies able to take these steps may be well-positioned to reap the rewards.
Read the blogAccording to an Oracle Health Sciences leader, companies looking to take on decentralized trials should keep a few things in mind before taking the plunge.
Read the articleTechnology, talent and specialization add up to a plethora of industry M&As.
Read the articlePharmacovigilance teams are under growing pressures from regulators seeking improved patient and product safety and compliance to analyze more data sooner, monitor risks more broadly, and accurately report patient events globally.
Read the blogMedical devices are becoming essential in clinical research and healthcare, and are increasingly more innovative with each passing year.
Read the blogReal-world use of machine learning algorithms are illustrating the power of this innovative breakthrough to the masses, but can these approaches be applied to clinical trials?
Read the blogWith unrelenting pressures to rein in budgets and cycle times, the application of project management techniques to study startup holds the key to optimizing operational efficiencies and compressing timelines.
Read the articleThe forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines renew the focus on efficiencies in conducting clinical trials and provide tools to do so — significantly impacting oversight.
Read the blogThe topic of missing data and how to handle it is one of the biggest challenges for clinical data management.
Read the blogWith changes in clinical research due to new technologies, new sources of data, and the COVID-19 pandemic, what impact will this have on you, your company, and your clinical trials?
Read the articleNow that the term decentralized trials is becoming more mainstream, it’s time to explore how this could be applied to organizations themselves.
Read the blogWith over two million medical devices on the market today, they can be used in many diverse settings and for multiple different reasons – so continuing to develop and innovate in this market is crucial to ensuring quality of life across the world.
Read the blogAs CROs look to streamline the process of implementing a clinical trial for a sponsor, it’s important to look at how technology can streamline the contracting process.
Read the blogLife sciences organizations around the world are starting to see the real-world benefits that AI technology can bring to their operations.
Read the articleOracle announced that Oracle Health Sciences’ Clinical One platform has been selected by Servier to unify their clinical environment to start new trials in a more efficient way, make mid-study changes in real-time, and unite everyone working on a trial in a common data environment.
Read the articleOracle Health Sciences' Clinical One cloud platform selected by Servier to optimize speed and data accuracy in critical clinical trials.
Read the press releaseThe clinical research ecosystem has undergone an incredible evolution over the past 18 months, and many want it to continue.
Read the blogDue to the recent accelerated adoption of decentralization in clinical trials, the industry is dealing with the challenges of transition.
Read the articleCompanies need to be prepared to move into a “digitalized future” where technology plays a central role in the safety process, from case processing to reporting.
Read the blogNew regulatory guidance will have a profound impact on all organizations engaged in clinical trials, encouraging the use of modern business methods and technologies.
Read the blogThere 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.
Read the blogOver 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.
Read the blogA leader from the clinical trial technology firm suggests ways to design research from the start to help accelerate studies and avoid stumbling blocks.
Read the articleIn 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.
Read the articleIntegration shouldn't be an afterthought when it comes to "knitting" together systems used to run a clinical trial.
Read the blogThere 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.
Read the articleAs 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.
Read the articlePfizer 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?
Read the blogHow is telemedicine being using in medicine and clinical research today, and will it still be widely used after the pandemic ends?
Read the blogExploring 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.
Read the blogCompressing schedules using parallelization represents the greatest opportunity to realize efficiency gains that are reproducible across all studies, and just on an as-needed basis.
Read the blogOracle’s Henry McNamara on the life sciences industry’s COVID-19 victories and the challenges ahead.
Read the articleClinical trials are the quintessential project, being both complex and requiring project management skills and techniques to bring them to a successful close.
Read the articleMaking 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.
Read the blogConcomitant medications can have a serious impact on the length and cost of a clinical trial. Con-meds impact patient eligibility, safety, and outcomes.
Read the blogAs 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.
Read the articleThe 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.
Read the blogRegenerative 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.
Read the articleHenry 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.
Read the articleBottlenecks can have punishing consequences on clinical trials and operational teams, forcing studies to get stuck in limbo when the delay lingers.
Read the blogSaama’s range of Smart applications will be integrated with the Oracle Health Sciences Clinical One platform to help users accelerate drug development.
Read the articleLearn how applying critical thinking, a key element of the new ICH E6 (R3) regulations, during study startup is pivotal to improving study conduct overall.
Read the blogFor 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.
Read the articleeClinical, eSource, and EHRs is the journey to the holy grail of data efficiency in clinical trials.
Read the articleThe 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?
Read the blogSaama Technologies has partnered with Oracle to offer life sciences industry artificial intelligence (AI) enabled applications to accelerate clinical trials.
Read the articleData, 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.
Read the articleKatie Klatt is a recovered COVID-19 patient and a participant in a COVID-19 antibody clinical study. This is her story.
Read the blogLearn how the integration of "best-of-breed" products designed to unify data can overcome the legacy hurdles of clinical development.
Read the blogExcel might be the most dangerous software on the planet, and its failings continue to grab headlines.
Read the blogDecentralized trials presents a challenge for clinical teams in regard to capturing, managing, and analyzing data from new sources, and in new forms.
Read the blogWhile healthcare providers have invested heavily in clinical systems over the past decade, they’ve mostly ignored financial and operational systems.
Read the articleHear industry experts discuss the data required for a successful AI implementation and where companies will get that data.
Read the articleCommunity by Current Health is now enrolling participants in a COVID-19 study that uses its FDA-cleared remote monitoring system.
Read the articleThe financial plight of healthcare providers amid the COVID-19 pandemic makes it more imperative than ever for HCPs to modernize their back-office systems.
Read the blogOracle is teaming up with digital life sciences firm Cognizant to hasten trial starts.
Read the articleLearn how innovative machine learning techniques are showing great promise in helping life science companies identify and rectify systemic inefficiencies.
Read the blogBy transitioning to a solution used by all CROs across the portfolio, oversight improves, and sponsors can build reliable institutional knowledge about CRO performance.
Read the blogOracle and Cognizant are integrating technologies in a move designed to help hasten trial launches, and get promising new treatments to market faster.
Read the articleQ&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.
Read the articleThe pandemic has created a lot of disruption in clinical trials, but not all of it has been negative.
Read the blogExisting regulations remain in place that can make it difficult to actually design and run a decentralized clinical trial.
Read the blogThe 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.
Read the blogAs 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.
Read the blogLearn about the collaboration between Cognizant and Oracle that eliminates redundancy for sites and delivers better outcomes for sponsors and CROs.
Read the blogLeaders in clinical research are working hard to synthesize what 2020 brought us and apply learnings to 2021.
Read the articleHow 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.
Read the articleSponsors 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.
Read the blogThis industry won't be going back to “the old way.” Oracle GM and SVP, Henry McNamara, makes predictions for sponsors and CROs in 2021.
Read the articleThere’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.
Read the blogFinal 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.
Read the blogHow 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?
Read the blogHow are organizations approaching the adoption of machine learning capabilities to the planning and execution of clinical trials?
Read the blogStakeholders 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.
Read the blogA recent survey conducted by Oracle reveals trial professionals’ thoughts, feelings and behavior around decentralized research in the face of the pandemic.
Read the articleThe 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.
Read the blogICON discusses the efficiencies gained moving their safety case management to the cloud while maintaining quality and accuracy.
Read the blog76% of industry respondents are now running some decentralized trials, but cite concerns with data collection and quality.
Read the blogWith 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.
Read the blogMany 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.
Read the blogICH E6 (R2) introduces the concepts of vendor oversight and risk management, but have these requirements been implemented jointly or as separate initiative’s today?
Read the blogAfter 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.
Read the blogThe 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.
Read the blogDiscover how machine learning provides critical operational insights, allowing organizations to learn and adapt.
Read the blogEvery 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.
Read the blog