Author: Joel Selzer

Our Collective Response to COVID-19

We are all finding ways personally and professionally to meet the challenge posed by COVID-19. 

Earlier this month, as the threat of COVID-19 was becoming increasingly clear, we at ArcheMedX took decisive action to protect our employees, their families, and our business partners by freezing all travel, ensuring we could work safely and securely from home, and investing in our data infrastructure to enhance business continuity.  These early decisions have served as a stabilizing force during the crisis, and like many other organizations, they have enabled the ArcheMedX team to focus its time and attention on collectively serving the larger community.

For example:

  • We quickly joined with thousands of business leaders to actively support the #stopthespread and #flattenthecurve national movement and led local efforts in our hometown of Charlottesville, VA, to unite CvilleBioHub, the Charlottesville Business Innovation Council, and the Charlottesville Regional Chamber of Commerce to launch #FlattenTheCurveCville and mobilize local forces in the fight against COVID-19
  • Several members of our team are donating their personal time and energy to assist local health systems in responding to critical shortages of personal protective equipment and assisting national healthcare and life science organizations in assessing how they can best adapt their educational initiatives and work practices in this new age of social distancing and restricted travel.
  • We have also collaborated with Johns Hopkins University, DKBMed, the Post Graduate Institute of Medical Education, and FreeCME to develop and distribute our first COVID-19 education and training experience to frontline healthcare workers free of charge (see below).

The educational activity, COVID-19: Keeping Up With A Moving Target, is powered by the ArcheMedx platform and was developed in collaboration with Dr. Paul Auwataerter, Clinical Director, Divisions of Infectious Diseases at Johns Hopkins University, DKBMed, the Post Graduate Institute of Medical Education, and FreeCME.

Please note: The initial presentation was recorded on March 18th and the intention is to provide weekly updates to this educational activity starting the week of March 30th. 

Day in and day out, our mission at ArcheMedX is not merely to improve online learning and generate actionable insights, but to support the healthcare and life science industries in the vital work of protecting life and advancing wellness.

To that end, we are offering free use of the ArcheMedX platform to deliver COVID-19 education and training initiatives to those on the front lines. This offer is available to any healthcare or life science organization that needs to provide critical information to clinicians or employees across the globe.

Please contact the ArcheMedX team to explore how we can work together to #stopthespread and #flattenthecurve.

Joel Selzer

CEO, ArcheMedX

Our Collective Response to COVID-19

We are all finding ways personally and professionally to meet the challenge posed by COVID-19. 

Earlier this month, as the threat of COVID-19 was becoming increasingly clear, we at ArcheMedX took decisive action to protect our employees, their families, and our business partners by freezing all travel, ensuring we could work safely and securely from home, and investing in our data infrastructure to enhance business continuity.  These early decisions have served as a stabilizing force during the crisis, and like many other organizations, they have enabled the ArcheMedX team to focus its time and attention on collectively serving the larger community.

For example:

  • We quickly joined with thousands of business leaders to actively support the #stopthespread and #flattenthecurve national movement and led local efforts in our hometown of Charlottesville, VA, to unite CvilleBioHub, the Charlottesville Business Innovation Council, and the Charlottesville Regional Chamber of Commerce to launch #FlattenTheCurveCville and mobilize local forces in the fight against COVID-19
  • Several members of our team are donating their personal time and energy to assist local health systems in responding to critical shortages of personal protective equipment and assisting national healthcare and life science organizations in assessing how they can best adapt their educational initiatives and work practices in this new age of social distancing and restricted travel.
  • We have also collaborated with Johns Hopkins University, DKBMed, the Post Graduate Institute of Medical Education, and FreeCME to develop and distribute our first COVID-19 education and training experience to frontline healthcare workers free of charge (see below).

The educational activity, COVID-19: Keeping Up With A Moving Target, is powered by the ArcheMedx platform and was developed in collaboration with Dr. Paul Auwataerter, Clinical Director, Divisions of Infectious Diseases at Johns Hopkins University, DKBMed, the Post Graduate Institute of Medical Education, and FreeCME.

Please note: The initial presentation was recorded on March 18th and the intention is to provide weekly updates to this educational activity starting the week of March 30th. 

Day in and day out, our mission at ArcheMedX is not merely to improve online learning and generate actionable insights, but to support the healthcare and life science industries in the vital work of protecting life and advancing wellness.

To that end, we are offering free use of the ArcheMedX platform to deliver COVID-19 education and training initiatives to those on the front lines. This offer is available to any healthcare or life science organization that needs to provide critical information to clinicians or employees across the globe.

Please contact the ArcheMedX team to explore how we can work together to #stopthespread and #flattenthecurve.

Joel Selzer

CEO, ArcheMedX

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We Can and Must Help #StopTheSpread

The threat of Coronavirus (COVID-19) is real and spreading. The most vulnerable among us (the elderly, immunocomprised individuals, and those with underlying health conditions) are at high risk of suffering from this virus. Public health experts and the CDC are urging more extreme social distancing, yet too many of us are still not listening. We have to do more.

Now is the critical moment when we, as leaders across the healthcare and life science industries, can take bold action ourselves — like those at Biogen, Eli Lilly, and Takeda who were the first in our industry to tell employees to work from home. At ArcheMedX, we moved swiftly to freeze work travel and enabled all employees to work remotely. We continue to work collectively as a team to slow the spread and prevent a far greater number of deaths by doing our part to “flatten the curve“.

Over the weekend, I joined with CEOs and leaders around the country to adopt the CEO #leadboldly commitment, designed to #stopthespread of COVID-19 in our community. Since Saturday night, more than 1,000 CEOs have pledged on behalf of their companies, and we’ve spread the message to more than 1.5M Americans.

We’ve all pledged to:

  • Enable our teams to work from home whenever possible, leading the way on that choice
  • Support our frontline workforce, our first responders and our healthcare workers, as they show up for work and fight this on the frontline
  • Ask you all to stop hosting or attending voluntary/social public events of any size
  • Support small businesses and their employees during this tough time with gift cards and online purchases
  • Free up time on our calendars to support our state and local communities as we move through this crisis

This is a clarion call for all healthcare, life science, and technology companies. The time to act is now, not tomorrow, not next week. These recommended steps require hard choices, but this is about protecting our front line healthcare workers and the most vulnerable in our community, and we need to work together.

TAKE IMMEDIATE ACTION. CLICK TO JOIN THE FIGHT.

MY ASK OF YOU —  share #stopthespread across your organization and community today on slack, facebook, twitter, instagram, linkedin, along with emails to corporate leadership, employees, and state and local officials.

WHEN YOU POST  —  don’t forget to share YOUR MOTIVATION to #stopthespread. Share how your organization and/or teams are working diligently to #stopthespread for sick parents & grandparents, for small business owners, for expectant mothers, for gig economy workers, for children, or for our healthcare workers fighting this on the front lines.

To this last point, if we fall short in flattening the curve than we WILL need significantly more ICU beds, respirators, and trained healthcare workers to care for the most vulnerable among us. Please call on your local, state, and congressional leaders to immediately take all necessary steps to dramatically increase the national supply of protective gear, respirators, and critical ICU equipment.

We can prevail by working together. Take action now and make a difference today, and above all, please be safe.

We Can and Must Help #StopTheSpread

The threat of Coronavirus (COVID-19) is real and spreading. The most vulnerable among us (the elderly, immunocomprised individuals, and those with underlying health conditions) are at high risk of suffering from this virus. Public health experts and the CDC are urging more extreme social distancing, yet too many of us are still not listening. We have to do more.

Now is the critical moment when we, as leaders across the healthcare and life science industries, can take bold action ourselves — like those at Biogen, Eli Lilly, and Takeda who were the first in our industry to tell employees to work from home. At ArcheMedX, we moved swiftly to freeze work travel and enabled all employees to work remotely. We continue to work collectively as a team to slow the spread and prevent a far greater number of deaths by doing our part to “flatten the curve“.

Over the weekend, I joined with CEOs and leaders around the country to adopt the CEO #leadboldly commitment, designed to #stopthespread of COVID-19 in our community. Since Saturday night, more than 1,000 CEOs have pledged on behalf of their companies, and we’ve spread the message to more than 1.5M Americans.

We’ve all pledged to:

  • Enable our teams to work from home whenever possible, leading the way on that choice
  • Support our frontline workforce, our first responders and our healthcare workers, as they show up for work and fight this on the frontline
  • Ask you all to stop hosting or attending voluntary/social public events of any size
  • Support small businesses and their employees during this tough time with gift cards and online purchases
  • Free up time on our calendars to support our state and local communities as we move through this crisis

This is a clarion call for all healthcare, life science, and technology companies. The time to act is now, not tomorrow, not next week. These recommended steps require hard choices, but this is about protecting our front line healthcare workers and the most vulnerable in our community, and we need to work together.

TAKE IMMEDIATE ACTION. CLICK TO JOIN THE FIGHT.

MY ASK OF YOU —  share #stopthespread across your organization and community today on slack, facebook, twitter, instagram, linkedin, along with emails to corporate leadership, employees, and state and local officials.

WHEN YOU POST  —  don’t forget to share YOUR MOTIVATION to #stopthespread. Share how your organization and/or teams are working diligently to #stopthespread for sick parents & grandparents, for small business owners, for expectant mothers, for gig economy workers, for children, or for our healthcare workers fighting this on the front lines.

To this last point, if we fall short in flattening the curve than we WILL need significantly more ICU beds, respirators, and trained healthcare workers to care for the most vulnerable among us. Please call on your local, state, and congressional leaders to immediately take all necessary steps to dramatically increase the national supply of protective gear, respirators, and critical ICU equipment.

We can prevail by working together. Take action now and make a difference today, and above all, please be safe.

Continue Reading

Pandemics Like Coronavirus Could Provide A Watershed Moment for Clinical Research

Above image: countries with confirmed COVID-19 cases as of March 10th. Credit: CDC.gov

Below image: workers disinfecting streets in Xiaogon city, China. Credit: AFP via Getty Images.

It often takes adversity to spur creativity and innovation. Events that threaten our safety or shake our confidence alarm us, and often compel us to think and act with increased speed and focus.

But when an industry leader, such as Biogen, instructs all employees in Massachusetts, Research Triangle Park in North Carolina, and Baar, Switzerland to work from home following news that 15 employees who attended a management meeting in Boston have now tested positive for COVID-19, it raises the stakes for all of us.

Biogen is not alone. In a company email last Sunday, Eli Lilly asked its employees to work from home and restricted domestic travel. A growing list of major medical conferences have now been canceled and IQVIA’s CEO said in mid-February, that in some parts of China, test subjects were already missing visits.

Even more striking, Italy locked down the entire country yesterday. And today New York’s Governor announced a Coronavirus containment zone in New Rochelle. We can try to ignore the signals, but the warning lights are flashing red and no one can predict what tomorrow will bring.

In today’s interconnected world, travel restrictions and supply chain disruptions in one region can quickly reverberate across the globe. The question we have before us is how we will respond. Will these events drive us to implement a far more efficient operating model, or will we hope to ride out the storm and continue to drag our heels.  In the past, we have told ourselves we don’t have the time, or the money, or that change is simply too difficult, or that the status quo is good enough.

We no longer have the luxury of slow rolling change and running away from innovation. When a pandemic restricts travel to sites, forces employees to work from home, and severely limits access to patients, we will feel the pain of our failure to evolve and to embrace the efficiencies a digital based model can provide. But when we are inefficient day in and day out, when we spend time and money we don’t need to spend, the delivery of new medicines and therapies is delayed and the costs to patients increase. Patients around the world suffer every day as a result.

The current global health scare represented by COVID-19 (and resulting economic and financial market turmoil) could prove to be the shockwave that finally pushes the clinical research industry to change, and that would be a welcome silver lining to this crisis.

Let’s Resist the Appeal of Half Measures.

All to often we take a piecemeal approach and launch trials with limited technology adoption, a half-step in the direction of modernization. Often new applications and digital tools are perceived as an added cost rather than a cost savings because we don’t adopt them in combination with the process changes and shift in resource utilization that they are meant to provide. Instead, the new technology is typically bolted onto the old, inefficient processes, making the monolith even bigger, slower, and more expensive.

Let’s not back existing processes and resourcing models into new technologies, especially given current events. Instead, let’s take fast, decisive action and embrace fresh thinking and all its potential. To steal an analogy from Henry Ford, let’s not attempt to strap an engine to a horse.

4 Pillars for Confronting the Pandemic and Accelerating Clinical Research

1. Embrace technology to drive efficiency.

Let’s take just one example to start, such as Investigator Meetings (IM), where technology can dramatically change how we operate.

At times when there isn’t a pandemic at hand, most teams don’t mind traveling to Monaco, Sao Paulo, or Berlin for the regional IM. However, when Italy is locked down and regional travel is severely restricted, those days may be long gone…at least in the short term.

Longer term, such meetings still cost millions of dollars, demonstrate limited ability to effectively prepare sites, and can actually slow down the startup process. Let’s imagine a new model that starts by replacing or reducing the number of IMs conducted in person around the world. Instead let’s focus on delivering more personalized, online experiences that enable all parties to cut travel, save time, reduce health risks, enjoy more effective learning experiences, and generate valuable data that informs clinical operations.

2. Use data. Streamline decision making.

As AI models continue to evolve, let’s think more practically how we can use data to inform clinical operations to make faster, better decisions that can dramatically improve protocol feasibility, take the guessing out of site selection, and accelerate site initiation and the first patient enrolled.

At a time when sites may limit or fully restrict non-essential personnel, let’s finally implement risk based monitoring and embrace novel forms of data that can help us to manage sites remotely and identify and mitigate risks sooner.

Taking this step today could enable study teams to tailor SIVs to limit travel and address site specific issues. It could enable risk-based models that result in smarter CRA assignments, limit IMV frequency and duration, and encourage more centralized monitoring that enables sponsors and CROs to retrain and redeploy critical resources in a challenging time. (Remember: Data can transcend a pandemic. Data doesn’t need a plane, train, automobile or entry visa.)

3. Empower patients. Employ hybrid virtual trials

Most of all, a trial cannot run without patients.  If travel is restricted, or schools are closed and parents must stay home, or study sites are forced to cancel visits, then we must be prepared to deliver investigational product, collect data, and successfully conduct the study wherever the patient resides. 

Over the past few years, we have heard the increasing call to embrace patient centricity echo across the industry, but now is the time to work through the logistical challenges and actually empower patients. To do so, clinical operations must adapt and ensure that our teams and patients are prepared to participate whether it is a siteless, virtual, hybrid or decentralized trial.

4. Work smarter whenever and wherever possible.

Let’s reward innovators. If they work themselves out of positions, let’s assign them to new challenges and reduce the fear that technology, process improvement, and efficiency mean smaller budgets and fewer people. Let’s focus on the fact that technology can deliver more available bandwidth and the opportunity to take on new work and expand. It can mean new skills and differentiated offerings, all leading to better opportunities for both patients and professionals.

Let’s Demand More from Ourselves.

We have a great history of rising to challenges. We have facilitated breakthroughs that have saved millions of lives and alleviated boundless suffering. We provide hope in situations where there has never been any. We do important work every day.

Let’s work smarter. Let’s be braver. Let’s not drag our heels, now or ever.

Recapping the Conversations at SCOPE 2020

After record attendance and a high energy atmosphere at SCOPE 2020 in Orlando last week, the ArcheMedX team wanted to share our key takeaways:
 
  • With an entire track dedicated to Quality & Monitoring it is clear that whether you are focused on your broader risk-based quality management strategy or still zoomed in on risk based monitoring, data visualization is key to identifying the insights that support decisions to mitigate risk. It was also evident that we are still chasing lagging indicators of risk and our models will benefit from identifying earlier leading indicators of potential issues.

 

  • Jennifer Ross solidly guided us through a discussion of basket, umbrella, and platform protocol designs and the necessary randomization methodologies. These different designs and their growing utilization continues to increase the complexity of the clinical trial landscape and reminds us of the essential nature of preparing project teams and site staff to execute on these designs.

 

  • Easing the burdens of participation for sites and patients was a theme that crossed multiple tracks. Whether it was partnering with advocacy groups, exploring the benefits of active listening, developing novel ways to collect protocol design feedback from sites and direct from patients, or demonstrating the continued technological improvements across our industry, removing obstacles and minimizing the burden for patients and sites to participate garnered much warranted attention.

 

  • It was refreshing to hear multiple speakers debunk the hype around the potential for AI and ML to transform clinical research and instead focused on more practical use cases. These presentations and the hallway conversations that ensued explored how sponsors and CROs are currently applying data analytics (and some meaty algorithms) to inform research teams today on how they can optimize study design, protocol feasibility, site selection, and risk based monitoring.

 

 
Learn how ArcheMedX helps to better prepare sites and inform clinical operations with a unique learning and analytics platform that improves clinical trial readiness.
 
 

Join the Conversation at SCOPE with ArcheMedX

SCOPE 2020 is almost upon us! 

This year, ArcheMedX is helping to shape the conversation on how we, as clinical operations leaders, can improve clinical trial readiness. It is our hope to connect with you and your colleagues in Orlando to spark a conversation that explores operational challenges  further and helps to identify practical solutions to increase trial preparedness.

We often ask industry leaders, “Given the months (or years) that you invest in planning a trial, are you confident that your sites and staff are ready to conduct the study? You may be surprised by how your team and fellow clinical operations leaders respond when answering this question.

In our conversations across the industry, most leaders recognize that their confidence is often based on wishful thinking (i.e., relying on past performance and completion of standard initiation steps) vs. hard data because they lack the ability to effectively evaluate how ready their sites and staff truly are. These challenges can be overcome by more experienced leaders who can quickly spot critical warning signs and navigate around painful challenges or even outright failure in their studies. 

To that end, we launched a new interview series “Conversations in Clinical Trial Readiness” with clinical research leaders to share the insights, lessons learned, and strategies to avoid the operational pitfalls that too often derail promising studies.

Please join our team at SCOPE for your own conversation:

  • Meet us for coffee and add your voice to our new interview series alongside leaders from Merck, ARG, Aperio and more!
  • Schedule a deep dive with our leadership team to discuss your readiness goals and learn more about ArcheMedX
  • Get live demonstrations of Ready, our clinical trials platform that improves project team and site readiness by analyzing behavioral data to inform clinical operations
  • Check our Clinical Research Blog during SCOPE for insights into the conversations taking place at the Summit

Click here to contact our team to arrange a conversation.

See you in Orlando!

Meet ArcheMedX During the 38th Annual JP Morgan Healthcare Conference

ArcheMedX is heading west January 12th-15th for the 38th Annual JP Morgan Healthcare Conference. Let’s connect in San Francisco to explore how behavioral science and actionable insights can improve clinical trial readiness and commercial success. 

Please contact our team to coordinate a specific time to meet during the conference and / or at the Virginia Reception on January 12th.


Join ArcheMedX, CvilleBioHub, and Virginia Bio to foster connections at the Virginia Reception during JP Morgan Week

Virginia-based companies are invited to a private Virginia Reception hosted by VirginiaBio and CvilleBioHub on January 12, 2020, the eve of JP Morgan Healthcare week, at the elegant Velvet Room in the Clift Hotel, just off Union Square. 

Sunday, January 12th 5-7pm at The Clift Royal Sonesta Hotel

Register to Attend

 

ArcheMedX Bolsters Team, Appoints Kelly Ritch as Vice President Clinical Research Solutions

Kelly Ritch’s addition better equips ArcheMedX to scale the capabilities it provides to transform clinical operations.

Charlottesville, VA (PRWEB) November 14, 2019

 ArcheMedX, the company improving clinical trial readiness, today announced the expansion of its senior leadership team. To support increasing demand for Ready, the company’s clinical trials platform, with sponsors and CROs, ArcheMedX has appointed Kelly Ritch as Vice President of Clinical Research Solutions. Kelly will apply her 20 years of clinical operations experience to accelerate growth of the company’s clinical research business.

“As the complexity and cost of clinical research increases, a key to reducing the risk of under-performing trials is ensuring the preparedness of staff and sites” said Ms. Ritch. She added, “I’m excited to join the ArcheMedX team and help clinical operations leaders make faster, more informed decisions that improve trial efficiency and outcomes.”

Kelly is a dynamic and innovative executive adept at driving high-performance and long-term value through the applied use of software, data, and technology driven solutions for clinical research. Her operational expertise and strategic mindset will enable ArcheMedX to scale the capabilities it provides to a growing customer base.

Nearly every clinical trial encounters operational challenges and according to industry reports 86% of trials experience a study startup delay and 72% of studies run more than one month behind schedule. These delays can have significant financial costs for each day that a trial impedes a product’s development and launch.

At ArcheMedX, we arm trial stakeholders with more than an advanced training solution —  we provide the early warning detection they need to mitigate operational risk and reduce costly delays,” said ArcheMedX CEO and co-founder Joel Selzer. “This is a pivotal time for the clinical research sector, and we are thrilled to have an industry leader with Kelly’s breadth of experience join the team. With Kelly’s appointment we are better equipped to expand the product and commercial strategies at ArcheMedX that will transform clinical operations.”

Kelly has previously led clinical data management, sales and marketing, clinical trial operations, and strategic partnerships with both sponsors and CROs.  While creating and leading high-performance teams across clinical research functions, Kelly has had the opportunity to evaluate, implement, and develop a number of key software platforms used to support and improve clinical trial performance. Kelly has earned degrees from University of Virginia, University of North Carolina Chapel Hill, and University of Virginia Darden School of Business.

About ArcheMedX

ArcheMedX applies behavioral science to transform learning and generate actionable insights across the life sciences and healthcare industries. Ready, the company’s clinical trial readiness platform, enables clinical research leaders to evaluate and improve the preparedness of project teams and site personnel and serves as an early warning detection system to reduce the risks and costs associated with under-performing clinical trials. To learn more about our operational intelligence and workforce readiness solutions visit www.archemedx.com or follow ArcheMedX on LinkedIn.