Author: Molly Bryant

Marketing to Healthcare Providers? Create Content Truly for Them

Relationships are built over time. However, with the inability to meet face-to-face, many life sciences commercial teams are left wondering how they should be marketing to healthcare providers in this new world.

Unfortunately, we have been truly disrupted – not only in our work environment, but in what healthcare providers (HCPs) want. A recent research report by Accenture revealed that 65% of HCP meetings with sales reps are now virtual and 43% of HCPs said that they are currently restricting who can enter the office for professional reasons. More importantly, many HCPs expect it to stay this way for the foreseeable future.

This is good news for commercial teams that are able to adapt. Virtual tools mean that marketing to healthcare providers can be automated more than ever before. Commercial sales teams can instantly connect with prospects (and do so more frequently). This means that relationships can continue to form – and even accelerate. However, it is going to take work to make this transition in your team.

Training and equipping your commercial team to be successful is one of the keys to success. 

However, there is more work to be done. If we want to be successful selling and marketing to healthcare providers, we must meet HCPs where they are. Then we must deliver what they need to succeed in their own roles in order to smooth the path for our sales teams to engage more effectively. 

It’s going to be difficult to stand out amid the constant onslaught of email marketing, webinars, and online sales demos. Therefore, innovators will take a different approach and go directly to the source, the HCPs, to discover how best to support and reach them.

To do so, there are a few steps you must take.

  • Understand What Healthcare Providers Want
  • Develop a Fully Virtual Content Toolkit for Selling and Marketing to Healthcare Providers
  • Launch Your Content Toolkit and Reveal Healthcare Provider Insights to Your Team

Understand What Healthcare Providers Want from You

With this shift in the way HCPs want to communicate with life science companies, you must spend the time to uncover not only how HCPs want to communicate, but what messages will stand out amid the digital noise.

The same Accenture report referenced above revealed overwhelmingly that HCPs want pharmaceutical and biotech companies to go beyond product knowledge. They need help, and they need trusted advisors.

One finding that the Accenture report revealed was that HCPs greatly value additional education and training that go beyond product knowledge, like best practices for treating patients remotely. Developing content and training that demonstrates clear value will ensure your messages stand out. To discover what that looks like, you should:

Research

Meet with a few HCPs individually to discuss and identify what they really need to learn about, besides your products. 

Ask: 

  • How can we help make this time easier for you?
  • What topics do you need more information about – besides products?
  • What best practices do you need help discovering?
  • How can we best deliver content to you?

Validate

Survey a larger group of HCPs to confirm what you’ve learned through interviews. 

Ask: 

  • Are these topics indeed valuable to you? 
  • Which are the most important to affect your ability to perform?
  • What are the best methods for delivery?

Refine

You may already have access to this type of research, otherwise this research and validation can be done within a couple of months. The data will be incredibly valuable to help you develop a plan for a virtual content toolkit. This will be the new foundation on which you will equip your sales team to become trusted advisors to their HCP customers.

Develop a Fully Virtual Messaging Toolkit for Marketing to Healthcare Providers

Like all of us, HCPs are facing difficult challenges and transition – but with the added complexity of caring for some of the most vulnerable members of our community. Their work is – quite literally – life-or-death. 

This stress point is a major opportunity for commercial teams to develop resources and support content to enhance their ability to perform at their optimum levels. And it all starts with the findings you uncovered from the interviews and surveys. 

Planning the Healthcare Provider Marketing Toolkit

Based on the information you’ve gleaned from the market, you now have enough information about what HCPs want – and how they want to receive it. 

There are many ways to develop a content toolkit, but there are a few things you must include:

  • Topic pillars. The topics you’ve identified from your research that HCPs want and need from you. 
  • Messaging Arcs. At the highest, and most succinct, level – what is the primary message you want to convey through each topic area?
  • Assets. The content, like videos, presentations, or slides that you will produce for HCP consumption in each topic area.
  • Distribution & Insight. How you will distribute the content to HCPs in a simple experience that allows you insight into their engagement.

It is this last item – Distribution & Insight – that provides the greatest opportunity for your sales team. That’s because if you choose a distribution method that not only delivers content, but tracks HCP consumption and behavior, your team will be able to clearly prioritize outreach. Plus, they will be equipped to lead with a targeted message for every interaction.

Enabling a Content Toolkit

So what does it take to build out this toolkit, and to distribute it?

For clients using Ready by ArcheMedX, most of the work has already been done by your team in developing the messaging arcs and assets themselves, based on the topic pillars. 

Distribution and behavioral analysis is handled by the Ready platform, but there are other tools that you can use to create a more basic content portal for your HCPs and more limited options to assess their engagement. 

The critical requirements that you must have in any tool are:

  • Ability to quickly deliver multiple types of content on-demand. Expecting HCPs to adhere to a scheduled webinar or to consume one form of content will reduce engagement.
  • Ability to not only track, but analyze, HCP interaction and engagement with the content. Human behavior is revealing and the behavior HCPs show around your content can be illuminating.  
  • Consumable insights that show which HCPs are ready for interaction with the sales rep, and more specifically how reps should prepare for and focus the interaction.

Building these assets and developing the toolkit will take some time, but once planned, it is an ideal opportunity to begin transitioning your sales team into their new approach to virtual selling. 

Give Your Sales Team a Deep Understanding of the Toolkit

To truly transform your sales team into a group of trusted advisors, you will need to equip them with knowledge and confidence across your content toolkit, using your chosen technology and tools, and how to sell consultatively. 

But on your team are a lot of different personalities, who are located in diverse locations, who all learn at different paces, have various learning styles, and are interested in different aspects of the content.

For these reasons, it’s ideal to deliver transformational sales content to these reps virtually, and on-demand. For more information on how to do this, we’ve prepared a new whitepaper to guide you through this process.

Launch Your Content Toolkit and Reveal Healthcare Provider Insights to Your Team

You already have a good idea of what HCPs want and need to be successful, based on the early research. And you’ve worked hard to do a great job of meeting their needs with your content toolkit. 

The final step is to roll it out to your HCP territories as a new set of content that will support them as they move forward with the changes they must make.

But though releasing the content toolkit may be complete, the benefits are only just beginning. That’s because the digital marketing to healthcare providers with such content opens up unlimited capability for you to glean insights on each contact’s behavior.

Upon launching your content toolkit you can utilize a variety of data products to identify general engagement trends. If you’re using a more advanced analysis tool like Ready by ArcheMedX, the platform’s predictive insights will enable you to discern individual HCP preferences and behavior based on how each HCP engages with specific topics and resources. With these insights, your sales team can strategically approach how they interact with each HCP using a targeted message or resource. 

Perhaps an HCP hasn’t been a high prescriber previously? Content toolkit insights will reveal if that’s because they lack understanding and need help. 

Perhaps an HCP has recently dropped their level of prescribing? Insights could show that they may have understanding, but lack confidence in when your treatment is best prescribed.

Perhaps an HCP has been a high prescriber and engages with everything you provide in your toolkit. This could be an ideal HCP to highlight for new content as a testimonial or health influencer.

These are just a few examples of the new types of insights the trusted advisor rep can use. And armed with this information, they’ll be able to better understand their HCP territory, prepare for every call with specific information that will add value to the HCP’s practice, and fully transform into a virtual selling powerhouse.

Continue Reading

Clinical Innovations Summit has gone virtual in 2020 – join us there!

Most, if not all, industry events have gone virtual in 2020. Clinical Innovations Summit is the most recent one to convert to an online setting, and it’s now combined with SCOPE Europe, usually held in beautiful Barcelona, Spain.

The ArcheMedX team is excited to be a cornerstone of this year’s Clinical Innovations Summit content – as we shine a spotlight on the innovation that must take place in our industry to move us past COVID.

On Wednesday, 11 November, our own EVP of Product and Clinical Solutions Kelly Ritch will team up with PRA Health Sciences on a session titled:  How PRA Health Sciences Virtualized Clinical Operations Performance Management.

This session will cover the reality that for many clinical operations teams, the amount of time spent on evaluating, discussing, and remediating team performance is overwhelming. However, PRA Health Sciences sought to virtualize performance management in order to: 

  • Better understand team members’ actual performance and ability to grow in their role
  • Help managers to prioritize team members’ remediation more accurately
  • Reduce workload by identifying unnecessary review activities
  • Streamline and automate individual remediation and upskilling

Join this session to learn how PRA built the business case for this undertaking, the process they used, and the outcomes they’ve realized from success.

Also on Wednesday, our CEO and Co-Founder Joel Selzer will join other industry experts on a break out panel titled: New Approaches to Improving Site Selection.

In this live breakout, the panel will discuss topics across three main areas:

  • Data: Novel data types and overcoming challenges to maximally leverage them
  • Relationships: Collaborations with internal and external groups, success stories, new opportunities to build valuable relationships
  • Wisdom: Challenges with bringing prior learnings to bear on future site selection planning and success stories in overcoming them

The Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) and Clinical Trial Innovation Summit have become a combined two-day event serving clinical innovation leaders, clin ops execs, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World.

The event features 8 keynote presentation and panel sessions, five conference tracks, interactive breakout discussion groups, and networking.

We’ll also be available within the conference site throughout the event for discussion.

See you online!

Women of Color in Pharma Launches “Ally is a Verb” Learning Activity with ArcheMedX

Women of Color in Pharma (WOCIP) has emerged as a leading organization teaching our industry how to empower women of color through bold action.

Their value to all of us is best explained in their “Our Why” statement, where they commit to “Creating a nurturing and safe environment for self-reflection and discovery amongst Black and Latina women to foster personal and professional growth that will address a critical gap required to promote innovation and leadership.”

Through many initiatives, not least of which is their annual conference, WOCIP has been a leading voice to promote the professional growth and development of female leaders of color in the pharmaceutical industry.

And now, ArcheMedX is honored to announce our partnership with WOCIP. We commit to amplifying their voice and their mission, through both support as a member, and as an active ally.

And as an ally, we want to highlight WOCIP’s first learning activity powered by ArcheMedX on the Ready platform, “Ally is a Verb.”

This learning activity, anchored by WOCIP’s recent panel discussion, is infused with valuable resources and tools and serves to illuminate the experiences and perspectives of Black and Latina professionals. This learning experience also exposes the responsibilities and opportunities that white and male allies have to elevate and support women of color in their professional journeys.

When ArcheMedX committed to take action to uplift and amplify Black and POC voices in recent weeks, we sought out new partners and specific opportunities. This partnership is just one way that we seek to take positive action where we have influence.

“WOCIP has been instrumental in the growth of so many admirable leaders in the pharma industry, and we are committed to amplifying their voice and the need for allyship. The time for dramatic societal change is long overdue, and the entire ArcheMedX team is aligned in this mission and honored to play a more active role. ”

We will continue to seek additional ways to support the Black community, and we urge others to do the same.

As we stated before, 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.

Choosing a Solution to Train Clinical Trial Site Staff Virtually? Start With this Checklist.

Choosing the right way to train clinical trial staff is complex and exhausting under normal circumstances. Today’s immense pressure to accommodate new virtual working styles across investigator meetings, site selection, and site initiation visits magnifies those challenges. As we revealed in our recent report, clinical operations leaders are adopting virtual tools everywhere they can so they can more quickly restart clinical studies. And in our recent report, COVID-19’s Impact on Clinical Operations, we discovered that the industry has a few major focus points for study start-up:
  • To virtualize everything possible
  • To better understand clinical trial site readiness
  • To specifically transition site selection, investigator meetings, and site initiation visits to virtual models
With those changes in mind, you need to be thinking about how you will transition all the training initiatives that are part of study start-up from on-site to remote. You’ll likely need to invest in technology to do this, but any software project can be confusing and difficult.  To make it easier for you, we’ve put together a comprehensive checklist so you can choose the right platform for your studies. Download it here.
Want the checklist in printable form? Download it here.

Choosing a solution to equip and train clinical trial site staff? Here’s what you’ll find on this checklist.

But now you need the technology to do just that – so check out this detailed checklist to help ease your load in the selection process. What you’ll find in this article:

Why choosing the right solution matters for your clinical trials

Outlining the outcomes your clinical trial solution must deliver

Defining the learning objectives for your trial sites

Factors You Need to Consider in Choosing a Platform

Must Have Features for Clinical Trials

Understanding Pricing

Why choosing the right solution matters for your clinical trials

We know that the majority of the industry is planning to virtualize the clinical trial start-up stage. The reality is that trial start-up activities are primed for virtual delivery. Most of them will scale better, perform better, and deliver better actionable data for decision makers in a virtual model.  And if you virtualize these activities successfully, then you will be able to gain efficiencies, ensure continuity of messaging, and greatly reduce many of the start-up delays you commonly encounter. But when it comes to selecting a learning platform, you have to remember that it will impact these three things:
  • How quickly you can select the right trial sites.
  • How quickly you can verify they’re prepared to enroll subjects.
  • How quickly you can actually start enrolling patients.
Many eLearning solutions exist today, and most of them focus on just the surface-level actions that you need to perform, like uploading content and delivering it to viewers. But there’s much more at stake with your clinical trial.

1. Outline the Outcomes Your Clinical Trial Training Solution Must Deliver

The best solution for equipping your trial sites is the one that successfully delivers the outcomes and objectives that you need to make better decisions about site start-up. These outcomes must go far beyond being able to upload a protocol, add additional resources or files, and distribute the content quickly on-demand.  More importantly, think about the real business objectives you have for your trial staff and focus on the outcomes required to more effectively conduct the study. Some examples include:
  • Move beyond simply identifying who has completed your site training, and who has not. Insead, measure how well individuals and site teams demonstrated comprehension of the protocol and processes.
  • Evaluate individual confidence in making the right decisions.
  • Reveal the sites and teams that are best-equipped for starting your trial now.
  • Uncover sites and teams that may not be prepared – but could quickly become ready with additional support and remediation.
You can see that these objectives are much deeper than just training – they’re focused on achieving successful study start-up. Thinking about your needs in this way means you’re more likely to choose a training platform that will provide you with measurable results.

2. Define the Learning Objectives for Your Trial Sites

In addition to your desired outcomes, you need a clear list of which procedures your team and site staff should be capable of performing at the end of your training curriculum.  Your objective for your team may be to identify which sites are best prepared. Meanwhile, your objective for sites could be that they are prepared to succeed with the trial protocol. Some ideas on what to include in your learning objectives:
  • Site staff must demonstrate they fully understand the protocol and enrollment criteria.
  • Site staff need to demonstrate confidence in making decisions about patient eligibility.
  • Site staff need to prove that they can make the right decisions after the training.
Certainly you can add more, or be more specific. But make sure you establish these objectives because they will influence your feature needs. Need more information on planning the right objectives and content before you train your clinical trial site staff? Check out our blog 7 Tips to Transform Training Content for Use in Clinical Trials.

3. Factors You Need to Consider in Choosing a Platform to Train Clinical Trial Site Staff

Now that you’ve established your objectives, there are other factors that you need to consider — before you get to features and functionality.

Industry focus

Despite the fact that there are many tools available that can deliver content, they’re not all up for the challenge of serving a clinical trial team. There are many nuances that you need a partner to understand, including the global nature of sites, the complex nature of the content itself, and your specific business needs. Ideally, choose a tool from a company with deep experience in clinical operations that can provide use cases and references in your industry.

Delivery

Is the training platform an on-premise solution that you have to host somewhere, or a fully SaaS enabled model? Is it available on-demand for site staff at any time, or is it a live-only solution? Does it offer automated engagement tools to re-engage site staff over time?  Be sure you understand how both the learning platform and content are delivered to your learners so you don’t select a “live only” meeting tool when what you really needed was something that offered “on-demand” training for a global trial.

Support

When things go wrong, and something always does, be sure you understand the vendor’s support model. Be sure you know who to contact for what – and pay attention to how forthcoming the vendor is during the early stages of your relationship. Also, will you be responsible for updates and patches, or is the tool a true SaaS product that includes all technical support? Be sure you know what is your – vs. the vendor’s – responsibility.

Scalability

Many tools can provide training for a few hundred users in a single location, but you may need something more scalable. Make sure that you understand the ability for any training tool to cross borders, and support a global trial — if only for the future.

4. Must Have Features for Anything You Use to Train Clinical Trial Site Staff

Every learning platform has their own set of unique features and functions. But in order to successfully prepare your clinical trial site staff, you need to make sure the platform you select has these following features.

Flexible content support

Content is the foundation of your clinical trial team’s success, and thus of your training. Any other feature succeeds only if your content is consumed.  You need to be sure you understand that the platform will support everything that you need to guarantee a fully comprehensive site training! Make sure you ask these questions:
  • Can I upload my protocol directly, or do all trainings have to be delivered as video?
  • What content types are supported (like PDF, image files, audio files, etc.)?
  • Am I limited in the content size or number of files?
  • How easily can we add new content?
  • How easily can we update existing content?
  • Can I reuse content across trainings?
These are all important use cases for clinical trial site trainings – and you likely have others you’ll add for your specific trials.

Annotated learning

Besides the base content itself, you need to understand how you can enhance the site staff’s learning experience to point them to specific key objectives in the protocol. This ensures that new or unique requirements of the protocol or processes aren’t missed and that site staff focus on your key study objectives. Annotated learning is a critical part of training your sites well, so make sure you require this on your checklist, along with some clarifying questions like:
  • How easy is it to annotate a piece of content?
  • Can I link my annotations to specific study objectives? 
  • What types of annotations can I use (like including an additional resource, a quiz, or an immersive multimedia file)?
  • Can I control how the annotation is presented based on its relevance?
  • How do I measure and evaluate how a staff member interacts with the annotations?

User behavior tracking

When we start to consider the types of reporting you need for your objectives, it’s wise to start with the basics. User tracking data is great for monitoring as a clinical operations leader.  It lets you gauge the learning tendency of the site staff. It also helps you check the amount of time they spend on a particular lesson or the number of attempts made for passing any assessments.

Assessment 

You absolutely must ensure you will receive the right insights on the performance of the site staff from your tool. Many training platforms are designed for very general use – where completion is straightforward. Often, in these tools assessments are limited to multiple choice. But for the demands of a clinical operations team, you need more. Remember that your main objective is to train the site staff so you can select and initiate the most ready sites. So ensure that your training platform offers more than just a “quiz” to validate their readiness. Add these questions to your checklist:
  • What types of assessments can we use in gauging trial site staff knowledge?
  • Do you offer confidence based assessment as a standard feature?
  • How can we design and adapt assessments to meet different training objectives?
  • Can we allow team members to “test out” if they’ve previously proven their knowledge? 
  • If test out is allowed, how much control do you have in setting the right thresholds?
  • What metrics do you incorporate in assessing site staff, and can we configure some of them?
The assessment functionality is critical to you achieving the objectives that you set out at the beginning of the checklist. Make sure you get the full story.  Want some additional ideas on assessment and metrics for clinical site teams? Check out our recent blog on 3 Metrics You Need to Add to Your Clinical Trial Site Selection Checklist.

Readiness scoring

The training platform’s approach to enabling clinical trial site readiness comes last, but it’s the most important for your purposes.  Ensuring that individuals and sites are sufficiently prepared (i.e., ready) to conduct your clinical studies is an essential part of keeping the many people who participate in clinical trials safe while ensuring the trial runs smoothly, remains in compliance, and stays within budget. The key to improving trial outcomes is having training strategies in place to improve trial readiness by effectively assessing and rapidly identifying those individuals and sites that will be high performers and those that may require additional training and support. So, make sure that your training solution is equipped to help you employ this critical part of assessing trial sites and team members. Ask your vendors how you can uncover these details about sites:
  • Which sites are demonstrating readiness and likely to succeed
  • Which sites are most likely to struggle and why
  • Which individuals do not fully understand the study’s key objectives
  • Which study objectives and key subject areas are misunderstood
  • Which personnel are likely to perform well and against which objectives. Can these people be strategically placed to mitigate a point of risk, or to tend to a high-value item?

5. Understanding Pricing

Your budget is always a major consideration, and every software product out there seems to have a different pricing model. The pricing model for a training solution may vary from vendor to vendor. Make sure you understand the entire cost of the project, as well as when fees might come into play.   Because there are so many pricing models, it’s very difficult to compare vendors on price alone. So instead, make sure you ask these budget questions to get the full pricing picture:
  • How is the product licensed? Per user, per site, per learning activity, one-time cost?
  • Are there hosting/support costs in addition to the license?
  • Are there additional annual costs associated with the software?
  • Are there implementation costs, like installation or setup fees?
  • Are there additional costs to activate new sites or add new staff?
  • Is there a threshold on content or on the number of trainings?
  • Will we need to purchase additional hardware or software to make the training platform work?

Remember that the right clinical trials solution for you is the one that meets your objectives

The great thing about having a checklist is that you control what items must be checked off, and what items are simply window dressing. When you need to train clinical trial site staff, though, you have to remember your primary objective is getting the trial started with the best equipped group of sites. Not every learning tool is up for the challenge, or specialized enough to give you the right insight you need. Want to download a copy of this checklist for your own use in choosing a solution for training clinical trial site staff? Get the PDF copy here.

The Virtual Clinical Trial Start-Up: How to Make It Work

Making it through the clinical trial start-up process is critical for any study – and takes a lot of effort under normal circumstances. But today, with the need to conduct more and more clinical operations remotely – it’s even more challenging. 

The good news is that there is a way forward, because as our recent survey and report revealed, study start-up is a priority for virtualization.

Since we can’t rely on the procedures we’ve used for years, how do we resume or start-up a trial in this new virtual world with new untested processes? How do we do it right? Let’s take a look at some actionable steps.

Deliver the Investigator Meeting with Virtual Meeting Technology

Our recent report revealed the PI meeting is a major target for a digital enablement. Prior to COVID-19, only 33% of the respondents to the survey felt PI meetings could be conducted virtually. But now – 65% of Sponsors believe that a virtual meeting can be just as — or even more — effective as a face-to-face one.

If you’re preparing to make this a capability in your organization, don’t make the mistake of thinking you can just repurpose your standard PI meeting content and deliver it via a web meeting tool. To really succeed with a virtual meeting, you will need to transform the agenda and design a different overall experience.

65% of Sponsors believe that a virtual meeting can be just as — or even more — effective as a face-to-face one.

If you’re preparing to make this a capability in your organization, don’t make the mistake of thinking you can just repurpose your standard PI meeting content and deliver it via a web meeting tool. To really succeed with a virtual meeting, you will need to transform the agenda and design a different overall experience. 

There are four key steps you should take to effectively virtualize the investigator meeting, all of which we describe fully in our recent blog “Running a Virtual Investigator Meeting in 4 Steps.”

To summarize, those four steps are:

  • Get your technology right. There are numerous technologies you can use to deliver a virtual meeting – from those that are specialized for clinical trials to those that just host a video. Make sure you choose the right one for your purposes. 
  • Plan and deliver a virtual-first agenda. Moving to a virtual meeting does raise the risk of losing your audience faster. Make sure you rework your content in a way that will improve attendee engagement and the outcome of your meeting.
  • Evaluate learning with analytics. A key benefit of digitizing content delivery and training is the rich data! Be sure to take advantage of the insights you can glean. For example, these data can inform site selection, site initiation, and monitoring decisions.
  • Demonstrate the effectiveness of your virtual meeting. If you’re putting in the work, take advantage of the outcomes downstream – for example, in proving you were more effective in site selection.

Inform Final Site Selection with Data from the Virtual PI Meeting

Our COVID-19 report showed half of respondents sought to use virtual methods exclusively for site selection, In fact, 70% of Pharmaceuticals respondents said they plan to replace in-person activities with virtual delivery for this important clinical trial start-up activity

This could mean great things for clinical trial start-up timelines. The average time to form a site list is around 2-3 months. The biggest benefit of virtualizing how you assess and select investigators and sites is speed. You can deliver it faster when you eliminate travel and dramatically improve decision making by gathering intelligence about the attendees and their readiness earlier. 

So how do we do this? Normal procedures involve the PI meeting as well as an on-site evaluation of the facility and staff. We can virtualize so much of that process using a virtual training platform like Ready, which offers assessment capabilities that greatly increase your likelihood of selecting the most capable sites.

Using a tool like this allows you to answer the critical questions for selecting the right sites to start-up, like:

How prepared is the site to recruit the right study patients? 

This is a critical priority in site selection, and the easiest to validate with a virtual process. For example, our clients use Ready to deliver content virtually to not only train – but also assess investigators and sites on their understanding of the protocol, eligibility criteria, familiarity with the patient population, and other indicators. This paints a truly accurate picture of whether a site can enroll. 

Does the site have qualified and sufficient personnel to conduct the study? 

Again, with a virtual model, you can more easily engage and evaluate additional site personnel beyond the PI to better assess (at scale) the capabilities of a site’s study team. Delivering training and assessment via a virtual, on-demand model allows you to be more inclusive and provides site personnel more flexibility to participate at a time and place that fits their already busy schedules.

Can the site use the electronic equipment and systems required? 

In a virtual model, you can deliver targeted training and evaluation around the use of critical electronic systems and other equipment more effectively to the right site personnel, increasing the chances for better start-up execution.

Utilize the blend of a virtual assessment with the delivery of study content to create a more informed site selection process. In the past, many trial teams had to rely on too little data or subjective information in choosing sites for a trial. 

Today, with virtual site selection methods – you don’t have to be limited. Let the data point you to the right sites who are ready to enroll and conduct the study.

Site Initiation Visits Can Go Virtual, too

Once you’ve selected your sites, we know there’s still a lot of work to do to activate them so they can start enrolling. Creating a virtual process to do this will help you in both the short-term and future studies. 

And it’s an area that the industry is focusing on: across our recent survey, 84% plan to increase their use of virtual delivery of training during site initiation. 50% overall plan to replace in-person meetings wherever possible for the SIV.

84% plan to increase their use of virtual delivery of training during site initiation. 50% overall plan to replace in-person meetings wherever possible for the SIV.

There are major tasks you can virtualize here: documentation, site staff training, and the site initiation visit itself. There are numerous tools to help you acquire necessary documentation and contract agreements from the sites, for example, which reduces time a great deal. 

But training the site staff and effectively virtualizing the meeting are areas of site activation that have remained manual for far too long. It’s a perfect use case for the deployment of remote and virtual technologies. And – if you’re planning to take your PI meetings virtual, you can and should use the same technology you adopt there for virtualizing the site initiation visit. By doing so, you can:

  • Create efficiency and scale (reduce travel, optimize staff assignments)
  • Reduce the work necessary to develop and deliver the training
  • Ensure consistency in what site staff are learning and evaluate their actual preparedness
  • Quickly identify risks in specific sites and staff ahead of the site initiative visit
  • Enable trial leaders to focus on the most critical study objectives for each site
  • Complete visits faster and with better outcomes – so that sites can begin enrolling patients sooner

In order to successfully virtualize your SIV, you need to consider the steps we wrote about recently in our blog on preparing your content for virtual training

Start with objectives for your site staff training. An example of an objective could be: “Site staff must be able to disqualify a subject that doesn’t meet criteria.” By starting with the objectives you wish to achieve, you can refocus every additional step you take to get there. 

Create your agenda with the objectives in mind. Create an outline – and tie each step in your outline back to your objectives. Protocols are rarely optimized for staff, doctor, or personnel consumption, but your training must be.

Use multimedia to encourage site staff engagement. Charts, graphs, and simple images are all effective to engage people visually with concepts.

Reduce your workload by reusing resources – and linking them in. You can encourage curiosity by adding additional, optional resources to your curriculum. It’s likely you’ve used some in creating your content already – so share what you already pulled! 

Use scenarios instead of multiple choice questions to assess decision making. You probably did case studies or an exercise in a large group at investigator meetings previously. Use the same activities for site staff to retain consistency. 

If you need to engage site staff over time, build in a follow up plan to encourage retention. Perhaps it’s a weekly email with a scenario, asking them to apply it. Or a short poll you send asking for responses each week to engage their memory.

Getting the Clinical Trial Technology Right

I’ve mentioned the technology you use a few times in this article. It’s critical that you select the right tool for your purposes. 

If you’re going to invest the time and resources in making the clinical trial start-up activities virtual, you want the resulting outcome to be a foundation for the future. And our recent study reveals that most of the industry is going this way:

  • 74% are adopting technology that supports virtual activities everywhere possible
  • 49% are converting all clinical operations meetings to virtual ones.

If you want to get the right clinical trial solution for the job, we’ve created a simple checklist that can help you.

Make the Clinical Trial Start-Up Your Priority

The trial study start-up is a complex set of processes, with many steps and people involved. The more complex the protocol, as well – the more risk there is to the timeline. 

And if study timelines are not met in the trial start-up, it greatly impacts the likelihood of missing other study milestones in the future. This is why it’s so important to prioritize the virtualization and efficiency of the clinical trial start-up. The ability to make many of these processes virtual will reduce preventable delays, and likely surface the risk of others so they can be avoided.

Technology has become the cornerstone for most of the workplace today, and now the clinical operations industry is moving to virtualize across the trial lifecycle. Want more information about clinical trial start-up said in the survey? The report is available now

Guessing could be adding 7 months of clinical trial delays. Here’s how to stop.

Getting new treatments approved has never been harder, but recent research reveals that the regulatory agency has also never been faster. So why is it getting more expensive and taking ever longer to bring a treatment to market? Three words: Clinical trial delays. 

It’s taking longer to bring a treatment to market, and clinical trial delays are partly to blame.

A recent study by Tufts Center for the Study of Drug Development revealed some shocking news: the clinical development of new drugs is lengthening, and not by days, but by months. This, despite regulatory approval time for new drugs in the United States shortening.

The actual numbers? 

Average clinical phase time increased by nearly seven months. Approval times dropped during the same time by nearly two months. In total, the time to conduct clinical studies and then complete the approval phase increased by 4.8 months.

This is a worrisome trend, worsened by our current environment fraught with delays due to COVID-19. So why is it happening?

Like any question in clinical research, the answer is complicated. However, we can point to a few truths:

  • Despite approval times reducing, regulatory agencies are keen for sponsors to include longer follow-up phases.
  • The treatments and associated trial designs continue to become more complex.
  • Delays continue to plague all phases of clinical trials.

Only the clinical trial delays are within your control as a sponsor or contract research organization (CRO). It’s well-documented that 85% of trials will experience a delay, so reducing delays is a worthy undertaking.

Let’s take a look at three places where you can – and should – stop guessing: investigator meetings, clinical trial site initiation, and clinical trial site problems.

1. Stop guessing about your investigator meetings.

When planning an investigator meeting agenda, many make assumptions about what the investigators know, and what they don’t know. We guess about what content they will find challenging and what they will find easy. And we guess about where they are going to need help. We guess…quite a bit.

Why? There are so many ways to surface what the attendees actually already understand today. We can use digital survey tools, through pre-assessments, or online knowledge analysis. 

There’s no reason to play this guessing game today and waste valuable time during the meeting. That wasted time could be spent emphasizing the critical topics that the investigators and study coordinators really need to know better. 

Better-prepared investigators and study coordinators will beget better-prepared clinical trial sites. Those sites will be better able to enroll and conduct your clinical trial, with fewer delays.

So how can we stop guessing? Some sponsors distribute a survey or ask for feedback after sharing a protocol synopsis. Others use a clinical trial solution like Ready to deliver a pre-meeting assessment or pre-meeting content. Doing so helps to understand attendees’ initial knowledge of and comfort with the planned study.

Investigator meeting content delivery will engage PIs and Study Coordinators around the content and critical questions ahead of time. This provides valuable insight to meeting planners and content developers. 

Want to go further? We recently covered how to deliver a fully virtual investigator meeting. A virtual investigator meeting will enable you to create a learning track that takes the same amount of time to develop, and much less cost to deliver. That’s because you can:

  • Prioritize content and topics based on pre-tests
  • Deliver the entire investigator meeting remotely and on-demand (reducing travel and meeting planning costs, and preventing delays at sites where the PI can not travel)
  • Prioritize follow-up content based on how the investigators and site staff perform in the training
  • Automatically send follow up content to re-emphasize critical points

Taking the guesswork out of creating your investigator meeting content, virtual or not, is a proactive step you can take to ensure that investigators and coordinators are prepared to operate at their highest level of performance. 

However, doing that alone is not going to eliminate clinical trial delays. Making your clinical trial site initiation process more accurate might.

2. Stop guessing in your clinical trial site initiation.

Many sponsors and CROs make decisions about which sites to initiate and when to initiate them using primary tools that are a bit outdated. Examples include: attendance records for investigators invited to the PI meeting, outdated historical site data, and site-provided data which could have dubious origins.

Sometimes, sites guess or inflate the number of patients that they believe they can enroll when completing the traditional site feasibility assessment. Sponsors and CROs anticipate this response and typically adjust the projections to fit their expectations for each site. 

So sites are guessing, and sponsors and CROs are responding to that with more guessing. And for an industry so focused on data endpoints and statistically relevant evidence, it’s shocking. This makes the frequency of delays in these clinical trials much more understandable. 

If you knew that removing the guesswork would reduce your clinical trial delays, wouldn’t you find a way to do so? 

More accuracy in clinical trial site initiation will reduce delays. And it is possible to achieve.

There is so much more accuracy available with digital clinical trial solutions today. As Kelly Ritch wrote previously: “We can leverage proven digital technologies and behavioral analysis to evaluate site feasibility in a more novel way that assesses the confidence, capability, and interest of site personnel.”

We can leverage proven digital technologies and behavioral analysis to evaluate site feasibility in a more novel way that assesses the confidence, capability, and interest of site personnel.

For example, combine your historical site data and performance with current, and specific, context to find the right-fit sites to initiate for any particular study. Measures can include the level of confidence and capability in this particular study’s area of focus for critical staff like the current study coordinator, the principal investigator and sub investigators. 

Or you could analyze these sites’ commitment to recruiting subjects for your study vs. their existing studies. 

You don’t have to restrict yourself to data that the site provides. Using a clinical trial solution like Ready, you could be delivering not only a remote investigator meeting, but a fully remote site analysis. Then you could determine which sites have both the historical performance and the current aptitude to succeed.

CROs and sponsors who do this deploy a remote interactive experience to prospective sites using the clinical trial protocol synopsis and key questions. As the site personnel engage with the content, the sponsors and CROs can measure their readiness and fit automatically. As a bonus, these sponsors and CROs are also gathering key inputs about the viability of the protocol first-hand.

The CROs and sponsors can quickly discover the site personnel strengths and weaknesses, their engagement levels, and how they rank vs. other potential sites.  This directly enables them to decide the order in which they should initiate sites to drive the best and highest quality enrollment.

Armed with this data, those trial teams know exactly which sites are most likely to succeed with the trial’s requirements. Even more exciting, they have new visibility into the risk areas for ill-prepared sites, and can stop guessing about site problems.

3. Stop guessing about the clinical trial site problems.

More than 1 in 3 clinical operations professionals struggle to know where and how best to help trial sites that aren’t ready to perform a trial. 

Most site problems fall into three categories:

  • Recruitment
  • Data and documentation
  • Protocol adherence

You probably have many SOPs and processes around addressing each of these. But why are you waiting to address them as they appear?

Some might suggest “additional clinical trial team training will reduce the downstream delays.” That may be true, but wouldn’t it be better, faster, and possibly cheaper to identify risk areas before you start with a clinical trial site? You may not have to push every site or staff member through additional training.

The best way to prevent clinical trial delays is to stop waiting, and be proactive. If you revert back to tip #2 – you reduce two different ways:

  • By starting your trial with sites that are less likely to experience problems
  • By identifying and remediating risk-prone sites before you start with them

Now, you can invest time and resources to upskill all or just some of those sites. Simultaneously, you can begin with limited delays from the best-equipped sites.

How does this work? 

As I described above, using a clinical trial solution like Ready, which is focused on not just training your clinical trial sites, but on predicting their performance, allows you to spot the high performing sites and those with gaps in knowledge or capability.

Better – you can uncover exactly what those gaps are. Then address them before a problem occurs.

Guess less, reduce clinical trial delays.

Sounds nice on paper, but shifting to a more data-centric approach to equipping your trial team requires thought and commitment.

We’ve created a thorough Definitive Guide to Clinical Trial Readiness, which can be a great next step for you as you focus on eliminating clinical trial delays.

Want more help? Take a demo of Ready, and see how you can be accelerating trial timelines with a comprehensive approach to clinical trial readiness.