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News and Blogs

Blog: Oracle delivers ROI in Clinipace global trials

11/22/21

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.

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Blog: Oracle joins Digital Medicine Society group to address sensor data integration

11/18/21

Oracle 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.

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Blog: Moving beyond 10 steps to clinical study startup

11/15/21

Today, 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.

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Article: Regulatory Forces Drive the Need For Advanced Planning In Study Initiation

11/10/21

Revisions 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.

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Blog: Connecting the clinical research ecosystem - part trois

11/08/21

The 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.

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Article: The proactive benefits of early adoption of ICH E6 (R3)

11/01/21

ICH 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.

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Article: New trial approaches have strong benefits, but industry worries about complexities

11/01/21

Trial 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.

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Blog: Connecting the clinical research ecosystem—part deux

11/01/21

The 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.

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Blog: Changing the face of men's health—"the mission behind the moustache"

10/28/21

Men around the world are facing a health crisis that isn’t being talked about, and it’s time to speak up.

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Blog: Clinical trial adaptations made during the pandemic reveal an industry embracing change

10/26/21

The 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.

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Article: Pandemic-driven changes in pharma here to stay as new clinical trial models take hold

10/25/21

COVID-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.

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Press release: Pandemic-Driven Changes in Pharma Here to Stay as New Clinical Trial Models Take Hold

10/25/21

Oracle survey shows 97% of pharma professionals will continue newly adopted clinical trial approaches as the industry evolves.

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Blog: New EU (536/2014) clinical trial regulation set to attract more studies and innovation

10/18/21

The 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.

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Blog: Five requirements to consider when evaluating cloud providers for GxP workloads

10/11/21

With high-performance computing and data science capabilities, the cloud can accelerate clinical research and development, getting new drugs and treatments to the market faster.

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Blog: Collaborating with patients throughout drug development

10/07/21

With patients at the center of clinical trials, it only makes sense that they can (and should) be involved throughout the drug development process.

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Blog: Clinical data FAIRification

10/04/21

By following and supporting the FAIR principles in clinical trials, Oracle can help the industry innovate for continuous improvement in quality, efficiency and collaboration.

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Blog: Oversight, often seen as a burden is actually a benefit to everyone

09/27/21

For 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.

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Blog: Digital Data Flow (DDF) initiative: manual to fully-automated study startup readiness

09/20/21

The 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.

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Blog: Are CROs prepared for ICH E6 (R3)?

09/13/21

As 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.

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Article: Prepping for success can streamline transition to decentralized trials: Oracle

09/08/21

According to an Oracle Health Sciences leader, companies looking to take on decentralized trials should keep a few things in mind before taking the plunge.

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Article: The Post-Pandemic CRO Landscape

09/08/21

Technology, talent and specialization add up to a plethora of industry M&As.

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Blog: Industry perspective on the future of Pharmacovigilance

09/07/21

Pharmacovigilance 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.

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Blog: Advancing patient health through medical devices - part II

09/02/21

Medical devices are becoming essential in clinical research and healthcare, and are increasingly more innovative with each passing year.

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Blog: Machine learning in clinical trials - hype or breakthrough?

08/30/21

Real-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?

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Article: Guest Column: Parallel, Not Sequential, Activities are Pivotal to Reducing Clinical Trial Cycle Times

08/23/21

With 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.

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Blog: Success with Clinical One - a customer perspective

08/23/21

Customers share their experiences in adopting and implementing Clinical One.

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Blog: How will ICH E8 (R1) and E6 (R3) make oversight more efficient?

08/16/21

The 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.

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Blog: Missing data and its impact on clinical research

08/09/21

The topic of missing data and how to handle it is one of the biggest challenges for clinical data management.

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Article: A Proactive Approach To Preparing For The Release Of ICH E6

08/05/21

With 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?

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Blog: Driving the implementation of decentralized clinical trials

08/02/21

Now that the term decentralized trials is becoming more mainstream, it’s time to explore how this could be applied to organizations themselves.

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Blog: Advancing patient health through medical devices

07/28/21

With 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.

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Blog: Modernization of site contracting using innovative technologies

07/26/21

As 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.

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Article: Why AI is a Game Changer for Pharmacovigilance and Safety

07/07/21

Life sciences organizations around the world are starting to see the real-world benefits that AI technology can bring to their operations.

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Article: Servier Selects Oracle for Trial Operations

06/30/21

Oracle 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.

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Press release: Servier Selects Oracle to Unify its Clinical Trial Operations

06/30/21

Oracle Health Sciences' Clinical One cloud platform selected by Servier to optimize speed and data accuracy in critical clinical trials.

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Blog: Renovating ICH guidelines to improve the future of clinical research

06/28/21

The clinical research ecosystem has undergone an incredible evolution over the past 18 months, and many want it to continue.

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Article: Addressing Roadblocks in Decentralized Clinical Trials

06/21/21

Due to the recent accelerated adoption of decentralization in clinical trials, the industry is dealing with the challenges of transition.

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Blog: NextGen Pharmacovigilance – a digitalized future

06/21/21

Companies 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.

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

06/14/21

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

06/07/21

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

06/01/21

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

05/20/21

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

05/18/21

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

04/30/21

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

04/28/21

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?

04/28/21

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?

04/27/21

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

04/29/21

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

04/26/21

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

04/19/21

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

04/15/21

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

04/14/21

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

04/12/21

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

04/05/21

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

03/30/21

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?

03/29/21

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

03/28/21

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

03/23/21

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

03/22/21

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

03/16/21

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

03/15/21

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

03/11/21

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

03/09/21

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

03/08/21

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

03/02/21

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

03/01/21

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

03/01/21

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

02/25/21

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

02/22/21

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

02/18/21

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

02/18/21

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?

02/17/21

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

02/16/21

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

02/15/21

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

02/04/21

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

02/08/21

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

02/04/21

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

02/02/21

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

02/01/21

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

02/01/21

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

01/25/21

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

01/19/21

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

01/14/21

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

01/11/21

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

01/07/21

"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

01/07/21

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

01/07/21

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

01/04/21

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

01/04/21

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

12/17/20

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

12/14/20

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?

12/10/20

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

12/07/20

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

12/03/20

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

11/30/20

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

11/23/20

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

11/19/20

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

11/18/20

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

11/16/20

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

11/12/20

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

11/09/20

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!

11/05/20

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

11/02/20

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

10/29/20

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

10/26/20

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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