Devana Brings Cloud-Based Collaboration to Clinical Trial Central Research Teams

Bringing Cloud-Based Collaboration to Clinical Trial Central Research TeamsThe pandemic has had a significant impact on the clinical research industry. In response to the COVID-19 pandemic, regulatory authorities have been calling for an increased adoption of decentralized clinical trials (DCTs). Devana Solutions has been pivotal during this time, helping central research operations teams collaborate safely and remotely on our platform and connect to decentralized site staff serving patients in underserved communities.

As a result, our PROPEL cloud solution has taken off as the superior research site-operations and analytics platform for leading research organizations, conducting decentralized trials, around the globe.

The Benefits of Decentralized Trials

More research organizations are moving to a decentralized trial model because they found success reaching new patients during the pandemic, as patients opted to stay home or avoid massive health care centers as part of their social distancing efforts.

Other advantages of decentralized trials include:

  • Accelerated patient access
  • Improved patient engagement and retention
  • Increased diversity

Challenge: Communication and Exchange of Data

One of the challenges that sites faced as they moved to decentralized trials was the ability to communicate and share data. These teams used to operate alongside the central research operations teams, but now they were operating in alternate locations.

Where central research operations teams had unlimited access to on-premise data and the ease of connecting with someone in-house, they were forced to operate through delayed communication or shared spreadsheets.

The Answer: Devana Solutions

Devana Solutions provided these teams with customized cloud software that brings clinical research sites to patients in these underserved communities so they can benefit from clinical research as a care option.

Devana’s cloud technology also allows highly-skilled research operations professionals to share protocols and other supporting trial documentation with decentralized sites and community-based providers.

More importantly, Devana allows centralized researchers to collaborate with the sites during study start-up and through trial completion, regardless of the trial location.

The future of clinical research is bright. As the industry continues to evolve, Devana Solutions’ capabilities will evolve, as well.

Learn How to Achieve Better Data, Better Decisions, Better Outcomes

Devana Solutions is an innovative cloud software provider that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Devana Solutions even bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trials systems.

Let us show you in more detail what Better Data, Better Decisions, Better Outcomes could do for your clinical trial processes.

Book a demo with Devana Solutions today to learn about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

Countermeasures Acceleration Group — the New Standard for Clinical Trials

Clinical Trials and Operation Warp Speed

248 days. From the time scientists first sequenced the genome of the COVID-19 virus and published it online, it took just 248 days for the clinical trials industry—working closely with government agencies under “Operation Warp Speed,” now known as Countermeasures Acceleration Group (CAG) —to develop two emergency-use vaccines to stem the tide of the pandemic. Other vaccines would be developed soon afterward.

 

With 5.2 million deaths and counting attributed to the COVID-19 pandemic worldwide, the loss of life alone has been staggering. Sadly, the Omicron variant will add to this devastating toll. Despite our desperation to put this pandemic behind us and return to “normal,” the clinical trials industry and its regulatory agency partners have a golden opportunity to implement some of the best aspects of CAG as the new industry standard. In so doing, the delivery of new therapies in record speed to patients desperately in need—those with diseases such as Alzheimer’s, Parkinson’s, Cancers—would stand as an enduring tribute to the lives lost to COVID-19.      

 

Formed May 15, 2020, CAG was a partnership between the federal departments of Health and Human Services (HHS), Department of Defense (DOD), and select private sector drug development sponsors. At its outset, the daunting goal of CAG was to accelerate vaccine development through 2020 so that, starting in January 2021, 300 million COVID-19 vaccine doses could be approved by the FDA, manufactured, distributed, and available to the U.S. general public by mid-2021.

 

At the inception of CAG, vaccine clinical trials were already underway with Pfizer, Moderna, Novavax, Sanofi/GSK, Janssen (J&J) and AstraZeneca. However, these trials were in the early stages, with no guarantees regarding timeline or successful outcome. And here was this lofty goal of full vaccine deployment in less than a year. For the nearly 75% of the U.S. adult population who have now been inoculated against COVID-19 and are currently contemplating booster shots, it may be easy to forget the audacity of such a compressed drug development timeline. But for those with experience in the clinical trials industry, this ambitious goal may have seemed flat out impossible!

 

If you look at the pre-pandemic statistics, the clinical trials industry has operated against a backdrop of 153,000 global deaths per day, 7,000 compounds in the drug development pipeline, and almost 12 years in clinical trials before new therapies reach patients—at an average cost of $2.6 billion! Defying the seeming inevitability of decades-long cycle times, CAG proved that an accelerated timeline was possible with an unprecedented level of process and performance transparency as well as cooperation between drug developers in the clinical trials industry and government. But what factors enabled this never-before-seen public/private cooperation to achieve the impossible, and how could those factors be standardized for future clinical trials in order to compress development cycle time and achieve faster breakthroughs in our most serious diseases?   

 

Allow each partner/stakeholder to play to its strengths  

In large part, CAG succeeded because at the outset, there was an understanding and acceptance as to which roles and responsibilities were best suited to private enterprise vs. government. For example, the heads of large government agencies such as HHS, DOD, and the State Department accepted that highly motivated, private drug development enterprises were best left to their own devices to do what they do best: execute on clinical process development and manufacturing plans—assuming successful vaccine creation.

 

For their part, the government agencies working within the CAG partnership deemed that their critical role was to mobilize the full capacity of the U.S. government to clear all roadblocks. Their job was to ensure that no technical, logistical, or financial hurdle would hinder vaccine development or deployment. For example, DOD and HHS collaborated to mitigate supply-chain disruptions of critical manufacturing supplies and equipment. HHS even worked closely with one vaccine company to identify a much-needed additional manufacturing partner. The U.S. Army Corps of Engineers was tasked with overseeing construction projects to expand capacity at some manufacturing plants. Incredibly, DOD even sent 16 public servants to fill quality control positions at two vaccine manufacturing sites until the companies could hire the required private sector replacements!

 

Certainly, promising early-stage clinical trial data should meet an agreed-upon threshold to merit such an all-out mobilization. But shouldn’t we lay down the policy guidelines now if only so drug developers and the public know that enormous public/private support will be there when a breakthrough inevitably comes? There are countless people with devastating diseases such as Alzheimer’s—which many experts caution is a developing tsunami given our aging population and longer life expectancies—waiting for just such a crucial breakthrough in treatment. 

Leverage technology-enabled solutions and data sharing to align stakeholders

Extraordinary cooperation by otherwise fierce competitors in the pharmaceutical industry became standard in the CAG effort to develop the COVID-19 vaccines. BioNTech collaborated with Pfizer for its mRNA-based vaccine. Sanofi worked in tandem with GlaxoSmithKline (GSK) and Merck manufactured J&J’s vaccine. Beneath these high-profile partnerships was one significant factor that helped CAG succeed: data-sharing. Specifically, the competitors developing vaccines on one of the four approved platforms selected by CAG—the mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform—actually relied on data from other vaccines using the same platforms. For as much criticism as the pharmaceutical industry too often receives, this level of sharing and cooperation between fierce rivals to help swiftly combat a deadly virus preying on many of the world’s most vulnerable has, in my humble opinion, not been heralded enough.  

 

As the CEO and Co-Founder of an innovative cloud-based software provider to the clinical trials industry, I have long advocated for more process and performance transparency (as those who know me in the industry can attest). That said, let me be clear: as an entrepreneur and fierce defender of risk taking and free market capitalism, I am not in any way advocating for pharmaceutical industry sponsors and their CRO partners to share the valuable intellectual property behind new therapies they took great risk to develop and advance through clinical trials. Beyond a passion for improving the human condition and eradicating disease, respect for the rule of law and protecting intellectual property are paramount to ensuring therapeutic breakthroughs like we’ve just experienced with the COVID-19 vaccines.

 

However, in the same collaborative spirit of Operation Warp Speed, there are opportunities to use technology to better align—both operationally and clinically—all clinical trial stakeholders, from patients to investigative sites to CROs and sponsors. On the clinical side, for example, technology that uses artificial intelligence to scour EMR data and match eligible patients to clinical trial protocols is beginning to proliferate. In addition, even during the development of clinical trial protocols, predictive analytics are being leveraged to model trial feasibility based on the protocol, thereby allowing for protocol adjustments to ensure a greater degree of success in the clinical trial phase. Operationally, the pandemic has hastened promising technological advances to cut cycle time and, ultimately, costs to deliver new therapies to patients. Remote and risk-based monitoring of clinical trials is poised to become (or already is) the new norm. And of course, at Devana Solutions we provide technology to connect central trial operations teams with decentralized site staff and clinicians or “bring the site into the patient’s own community”. Devana also highly automates clinical trial process workflows and capture site metrics for analysis and improvement in speeding new therapies to patients.

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It is within our power to take from the urgent, can-do, cooperative partner-mindset that was adopted by the clinical trials industry and government agencies during the pandemic—best exemplified by Operation Warp Speed. The industry and regulators should seize the lessons of this moment, and lay down a framework to accelerate the speed of delivery as soon as the next major therapeutic breakthrough against a serious disease is realized. To miss the next opportunity to speed a lifesaving vaccine or cure to those patients by leveraging the collective fighting spirit this pandemic has engendered would be tragic. Rising to meet this challenge would honor the millions of lives cut short by this pandemic.

 

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

Why Automated Data Analytics are Crucial for Clinical Research Leaders

The sheer volume of data produced by the clinical trial industry is staggering—and it’s growing every day. The healthcare industry, in general, relies on big data to function, and clinical trials are no exception. We need speedy, secure access to data sets that are large, complex, and diverse. By and large, big data has moved onto the cloud in recent years. Yet because of the limitations of the applications and processes used by most clinical research organizations, much of the information remains siloed in different systems. We end up spending hours trying to wrangle data from multiple sources in an effort to get the insights we need to effectively manage operations. But what if the clinical data you need wasn’t just scattered across multiple software systems (and spreadsheets)? What if you had a single platform from which to manage all of the information you need to maximize the efficiency of your research and speed medications and treatments to the market? What if, instead of sifting through disparate systems to gather and analyze pertinent data, you could automatically generate your data analytics with a few clicks? Below are just a few of the opportunities made available through automated data analytics. 

Optimize Clinical Trials

With the ability to analyze trial performance data in real-time, you’ll easily choose the best sites and investigators for your research, track trial progress, make informed decisions, and improve outcomes. With more accurate data, you can improve trial efficiency and lower overall costs.

 

Ensure Accuracy & Improve Data Quality

A streamlined platform that can integrate your systems will improve the accuracy and quality of your data. Manual methods of data gathering are tedious and prone to error. With automated data analytics, it’s much easier to see inconsistencies and gain valuable insights, and you’ll save valuable time.

 

Speed Up Treatment & Drug Development

With access to more historical data and the ability to analyze it automatically, you’ll gain better insight into the potential outcomes of current and future trials. A more efficient trial process also accelerates the pace at which you can develop new medicines and treatments—and get them to the patients who need them. 

These are just a few of the benefits automated data analytics can bring to clinical research leaders. With a cloud-based SaaS that integrates seamlessly with CTMS and other key systems to provide you with automated data analytics in real-time, you’ll get instant access to the insights you need to make better decisions and increase your chances of a successful outcome.

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.

 

Transform Your Clinical Trial Processes in 2022

While those of us who work in the clinical trial space have always known that the importance of our work cannot be overstated, there’s no question that the COVID-19 pandemic has driven home the importance of the clinical trials industry to the rest of the world as well. As we reflect back on the events of the past year, Devana Solutions is proud of the role we have played in supporting the development of life-saving vaccines, treatments, medical devices, and medications that have had a positive impact on quality of life for the patients who received them. As we look forward to 2022, we remain dedicated to supporting new discoveries in the field of medical research.

At Devana, we know that clinical trials are an essential part of ensuring that real people get the care they need to live better lives. We’re also aware how limited the options have been for managing clinical trial processes. Labor-intensive manual data entry and scattered spreadsheets with incomplete or missing information are common. Often “the left hand” will have no idea what “the right hand” is doing, especially if both of those “hands” belong to a research organization conducting more than a handful of trials at once. That’s why we developed our technology—to help you bring your goals for the future of medicine into alignment with your capabilities as a site, CRO, or sponsor. 

While there’s no telling what kinds of challenges 2022 might bring; the cumbersome, error-prone processes you currently struggle with don’t have to be among them. Imagine, instead, the opportunities that will unfold with Devana’s clinical trial technology that provides you with a single, cloud-based platform with real-time data.

From pre-award through  trial completion, our platform lets you effortlessly manage all of the information along the way. Clinical trial processes become a snap when you have instant access to all the necessary data required. You won’t have to worry about inaccuracies slowing down the trial award process and startup stage, because all of the necessary data for a site can quickly and easily be assessed and shared with CROs and sponsors. 

As your single solution to standardize, streamline, and automate all of your clinical trial processes, our platform will help you align with the right trials and speed therapies and treatments to the patients who need them most. Let 2022 be the year you take the first step towards transforming your clinical trial processes with Devana Solutions.

Book a demo with Devana Solutions today to learn more about our cloud-based data analytics software for the clinical trials industry that integrates seamlessly with CTMS and other key systems to keep success in the crosshairs.