Author: Joel Selzer

New ArcheMedX Report “COVID-19’s Impact on Virtual Tech in Clinical Trials” Reveals Changing Priorities for Sponsors, CROs in a Remote World

Today, ArcheMedX, a leader in behavior-based learning and operational insights for life sciences and healthcare organizations, announced the results of its new survey, “COVID-19’s Impact on Virtual Tech in Clinical Trials.” The findings reveal brand-new insights into how clinical trial leaders in pharmaceuticals, biotech, and clinical research organizations are accelerating the use of virtual solutions to advance clinical research in the current and post-pandemic environment.

The report found that 89% of trial leaders are rapidly adopting remote and virtual technologies, particularly across study start-up, and cutting through the inertia that often hinders such changes. These insights are especially relevant, as clinical operations teams increase the pace of resuming studies in an effort to pursue clinical research despite the continued impact of the pandemic. 

89% of trial leaders are rapidly adopting remote and virtual technologies, particularly across study start-up.

More specifically, sponsors and CROs showed that clinical trial start-up activities were the most “digitally immature” and thus most ripe for virtualization. Across site selection, investigator meetings, and site initiation, respondents overwhelmingly agreed that they will be increasing the use of virtual methods, or replacing face-to-face interactions altogether. 

The ArcheMedX report revealed that sponsors and CROs are also more concerned about how they select and prepare study sites to conduct their trials. Despite a majority of sponsors and CROs believing their approach to preparing sites was effective pre-COVID, 80% now believe they need to improve which sites fully understand inclusion/exclusion criteria for a trial and 73% report they need to improve their ability to identify which sites understand IP and sample management. Overall, 78% of respondents now say they have major improvements to make in identifying trial-ready sites. 

Overall, 78% of respondents now say they have major improvements to make in identifying trial-ready sites. 

“The results of the survey confirmed what we’ve heard anecdotally for years: that clinical operations leaders — both sponsors and CROs — recognize that they’re losing valuable time to preventable errors and delays due to ineffective study startup processes,” said Joel Selzer, CEO of ArcheMedX. “COVID-19 has forced sponsors and CROs to embrace a new, virtualized approach to selecting, preparing, and initiating teams and sites which can dramatically improve overall study performance.”

Both sponsors and CROs — recognize that they’re losing valuable time to preventable errors and delays due to ineffective study startup processes.

For example, COVID-19’s restrictions have catalyzed the industry into a major change in perception around the utility of virtual meetings. 61% of sponsors said they are converting all clinical operations meetings to virtual ones, including Principal Investigator (PI) meetings and site initiation visits. 

Most striking, 74% of respondents now believe that virtual PI meetings can be just as or more effective than those conducted in person vs. the 68% who had said PI meetings should only be held in person before the pandemic. The report also found site initiation visits ripe for virtual disruption – with 74% of sponsors committing to increased virtual delivery during site initiation and 90% of CROs seeking to fully virtualize site personnel training.

74% of respondents now believe that virtual PI meetings can be just as or more effective than those conducted in person.

“COVID-19 has forced us to see the benefit of having virtual/electronic systems in place to mitigate unforeseen occurrences along the lifespan of a clinical study. Electronic tools are obviously not new, but embracing the tools is uncomfortable,” said Kevin Crawford, Director of Clinical Operations at Tenax Therapeutics, Inc. “I find it interesting, but not surprising, that the ArcheMedX report shows CROs to be more bullish on the technology, especially around investigator meetings and training. Without having a modality to distribute their knowledge to a CRO in a systematic, verified, trusted way, there is a reasonable concern that the study is “being thrown over the fence.” It may be unnecessary angst, but based on ArcheMedX data, it certainly exists.”

I find it interesting, but not surprising, that the ArcheMedX report shows CROs to be more bullish on the technology, especially around investigator meetings and training.

ArcheMedX provides a software platform, Ready, that enables CROs and Sponsors to predict and improve clinical trial site and team performance. The findings in the report mirror the increased adoption Ready has experienced across the industry as the platform reveals precisely which sites, teams, and individuals are likely to be high performers and enables CROs and Sponsors to remediate potential risk areas — earlier than ever before. 

According to Kelly Ritch, EVP of Clinical Research Solutions at ArcheMedX. “Sponsors have made it clear that they’re expecting to adopt virtual technology throughout the study start-up – which has been primarily conducted in-person until now. This also aligns perfectly with their increased need to better measure trial site readiness, as the wider adoption of virtual technology makes more accurate site and team assessment a reality.”

Get the full report

Virtual Tech Use in Clinical Operations

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Turning Conversations Into Positive Change

Recent events have struck at the very soul of our nation. They demand nothing less than our immediate attention and swift action. 

We must recognize that our Black friends, colleagues, family members, and neighbors carry an undue burden. We, society at large and each of us individually, have failed them. We may recognize and condemn the systemic hate, racism, and inequality the Black community continues to endure, but we have not done enough. We must do more than issue statements and encourage conversations. 

We will only see true change in our world if these difficult conversations turn to positive actions.

At ArcheMedX, we believe in taking action and will always stand in solidarity against racism, inequality, and discrimination. There is no place in our hearts, in our company, and in our country for hate and divisiveness. We commit ourselves to taking corrective actions that will help in healing these deep seeded wounds and will work collaboratively with any and all partners to end discrimination and suffering in our community and our world. Though we can not change the past, we can learn from it and change the future.

As a company, we are committed to taking these initial actions:

  • We will work diligently in our company, our communities, and our own homes to improve understanding and drive the narrative that racism is intolerable and that it’s up to each individual, institution, and community to ensure equity, inclusion, and a true sense of belonging.
  • We will work with our healthcare and life science partners to develop new education and training programs that promote equality and an end to systemic racism. To accelerate these efforts, we will provide our services free of charge and make use of the ArcheMedX platform available at no cost to deliver more effective online learning experiences in these critical areas.
  • We will increase the diversity of our own team and ensure that we invest in recruiting and developing talent programs that increase awareness and opportunities among Black candidates and all communities of color.

There is no excuse for discrimination and mistreatment of anyone, especially because of their race, gender, sexual orientation, disability or any other characteristic.  We must ALL commit to taking action and that begins in our own small corner of the world. 

The ArcheMedX team will do more than elevate the conversation, we will become an active part of the change we so desperately need.

Joel Selzer

CEO, ArcheMedX

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Turning Conversation into Positive Change

Recent events have struck at the very soul of our nation. They demand nothing less than our immediate attention and swift action. 

We must recognize that our Black friends, colleagues, family members, and neighbors carry an undue burden. We, society at large and each of us individually, have failed them. We may recognize and condemn the systemic hate, racism, and inequality the Black community continues to endure, but we have not done enough. We must do more than issue statements and encourage conversations. 

We will only see true change in our world if these difficult conversations turn to positive actions.

At ArcheMedX, we believe in taking action and will always stand in solidarity against racism, inequality, and discrimination. There is no place in our hearts, in our company, and in our country for hate and divisiveness. We commit ourselves to taking corrective actions that will help in healing these deep seeded wounds and will work collaboratively with any and all partners to end discrimination and suffering in our community and our world. Though we can not change the past, we can learn from it and change the future.

As a company, we are committed to taking these initial actions:

  • We will work diligently in our company, our communities, and our own homes to improve understanding and drive the narrative that racism is intolerable and that it’s up to each individual, institution, and community to ensure equity, inclusion, and a true sense of belonging.
  • We will work with our healthcare and life science partners to develop new education and training programs that promote equality and an end to systemic racism. To accelerate these efforts, we will provide our services free of charge and make use of the ArcheMedX platform available at no cost to deliver more effective online learning experiences in these critical areas.
  • We will increase the diversity of our own team and ensure that we invest in recruiting and developing talent programs that increase awareness and opportunities among Black candidates and all communities of color.

There is no excuse for discrimination and mistreatment of anyone, especially because of their race, gender, sexual orientation, disability or any other characteristic.  We must ALL commit to taking action and that begins in our own small corner of the world. 

The ArcheMedX team will do more than elevate the conversation, we will become an active part of the change we so desperately need.

Joel Selzer

CEO, ArcheMedX

Contact Tracing: The Vital Importance of a Nationwide Commitment

For months, public health experts have shared a constant refrain, stating that widespread testing and comprehensive contact tracing are essential to stopping the spread of COVID-19. In policy papers, Congressional briefings, and media interviews, they have carefully explained why contact tracing systems should be in place before cases become more widespread. This would allow for every new infection to be tracked and the affected individual’s contacts identified, tested, and isolated from the rest of the community.

In the absence of a national effort, many states — both red and blue — have heeded the expert advice. California, Massachusetts, Michigan, New York, North Carolina, South Dakota, North Dakota, and Utah moved quickly to launch statewide contact tracing initiatives and mobile applications. Additional states have started their own tracing efforts, but with all 50 states now reopening, we must recognize the magnitude of the challenge and act accordingly.

Lest we forget, we are one United States and the coronavirus doesn’t stop at one state’s borders or respect its local policies.

 

A Big Solution for a Big Problem

While training individuals to do contact tracing is not a formidable task, the numbers involved are huge and it requires scale. Our public health workforce must be vastly increased:

The national, comprehensive plan that the Johns Hopkins Center for Health Security released last month explains why the U.S. requires at least 100,000 new public health workers to conduct contact tracing. More recently, Andy Slavitt, former director of Medicare and Medicaid, and Scott Gottlieb, former Food and Drug Administration chief, urged Congress to appropriate funds to employ 180,000 contact tracers until there is a vaccine. Tom Frieden, a former director of the Centers for Disease Control and Prevention, suggested the U.S. may require as many as 300,000 contact tracers nationwide.

Despite the clarion call from so many well-respected institutions and public leaders, most states still lack the workforce and tools to effectively implement contact tracing at the scale experts are calling for, especially as a potential resurgence of COVID-19 looms in the fall.

Most agree the country cannot stay locked down until a vaccine is made widely available (best case in 12-18 months) and contact tracing and isolation is a proven method used to help contain past epidemics in the U.S. ( i.e. Tuberculosis). During coronavirus outbreaks, notably SARs, MERS, and now with COVID-19, many other nations have also relied on robust tracing and isolation efforts to slow the spread and contain their outbreaks.

Technology can help to streamline and accelerate the tracing process. While other nations have successfully deployed digital tools and contact tracing apps, the U.S. lacks a national approach. Apple and Google’s collaborative solution to enable tracing at the operating system level in smartphones was widely applauded early on. But now, many states fear that Apple and Google’s effort to protect individual privacy will result in a contact tracing effort that is inadequate. As a result, more states are pursuing development of their own contact tracing apps instead of working toward or implementing a standardized approach.

Thankfully, MIT and other groups have also been working on ways to securely employ Bluetooth enabled applications across Android and Apple devices to privately and securely track and share contact information.  They may yet arrive at the right solution.

 

The Johns Hopkins Plan as a Foundation

The Johns Hopkins plan includes a clear explanation as to why contact tracing is critical to safely reopening the country and walks through the evidence and data drawn from the experiences of other nations. If you haven’t read it, please see it here. We’ve created a learning activity around the plan, making it easy to delve into the subject in a deeper, richer, more engaging way. The activity is available to anyone, free of charge.

Learn More About the National Plan for Comprehensive Contact Tracing

We think it’s only fitting that a company built to transform learning and improve healthcare would lend a hand in elevating and expanding the debate around contact tracing. Note that since our platform makes it simple to update learning activities quickly, we are adding and editing multi-media references and tools to improve understanding of the plan as the conversation evolves.

 

Meeting the Challenge Together

This pandemic has forced a seismic shift in the healthcare/life sciences industry, if not in our society as a whole. Now we must decide whether we will let the virus beat us or employ proven methods, particularly contact tracing, to contain it and safely re-open the country as we begin a new way of life.

This nation can rise up and meet the challenges of this pandemic, just as our forefathers have done in other challenging times. We have the experience, talent, ingenuity, and technology to ensure the public’s health. Let’s embrace it.

Learn more about the issues surrounding contact tracing. Find our activity here.

Making a Positive Impact During COVID-19

We have all witnessed the remarkable dedication of our first responders and healthcare workers as they fight each and every day to save the old and young battling COVID-19. There are many more heroes working in meat processing plants, food stores, delivery services, and pharmacies (to name just a few), who place the needs of our community above their own health and safety in many cases. Those of us not on these front lines, but with the will and the means to make a positive impact, are all trying to contribute both personally and professionally.

In the weeks since I outlined the steps we took as a company in response to COVID-19, I have never been prouder of our team at ArcheMedX. Like many of our colleagues across the industry, we have been working overtime to support our healthcare and life science partners AND to develop new solutions in the fight against COVID-19.  Given our collective experience and resources, we have focussed our efforts at improving the knowledge and preparedness of frontline healthcare workers, clinical research teams, and public health professionals.

To that end, we accelerated development of a new PDF centric learning and insights solution and rapidly produced two additional COVID-19 related learning Activities to assist the clinical research and public health communities during this difficult period. Both Activities are offered free of charge and layer expert advice and multi-media resources around essential documents in this fight.

Ensuring Clinical Trials Continue During the Pandemic

There are now more 650 clinical trials racing to deliver a medication or vaccine for COVID-19 and every clinical operations team is adapting to changing conditions on the fly.

This pandemic represents a seismic shift in how clinical research is conducted and our FDA Guidance Activity was developed to assist these clinical operations teams in understanding how to interpret and apply the “FDA’s Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic“.  This activity layers expert advice and practical resources in and around the latest FDA guidance that was issued on April 2nd and is intended to help clinical operations better prepare for today’s trials and tomorrow’s emerging challenges.

Click here to access the FDA Activity.

Investing in Public Health Infrastructure to Contain COVID-19

Whether or not you agree with the push to relax social distancing and re-open the country, public health experts agree we need far more extensive testing and the ability to contact trace and isolate cases to prevent future spread of #COVID19.

ArcheMedX Activity - Johns Hopkins National Plan for Contact TracingTo help achieve this goal, the Center for Health Security at Johns Hopkins University authored a national plan to implement a comprehensive contact tracing program that calls for at least 100,000 new public health workers. Our Contact Tracing Activity was rapidly developed to increase awareness and understanding of the, “National Plan to Enable Comprehensive COVID-19 Case Finding and Contact Tracing in the US.  This Activity layers expert advice and multi-media resources from the CDC, WHO, Johns Hopkins, MIT and other global institutions around the national plan to explain why the need for widespread testing and contact tracing is so critical.

Click here to access the Contact Tracing Activity.

Please explore the Activities and share them with your clinical research and public health colleagues. Let’s work together to increase awareness of how we can contain the spread of #COVID19.

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.

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