Panorama: Customized Thought Leader Data and Insights for Life Sciences Companies

One of the key factors in the success of a new medical product is how well-accepted it is among healthcare practitioners (HCPs) and patients, both during development and upon commercialization. Life sciences companies often rely on thought leaders—sometimes also called opinion leaders—to help both spread information about a new product and to better target development and marketing efforts for new drugs or medical devices. And to use these individuals to their best potential, companies need to be able to quickly and easily identify which thought leaders are most important for their particular products.

Healthcare thought leaders or opinion leaders can be a factor in both recruiting patients to participate in clinical trials and maximizing acceptance of new products after commercialization. Thought leaders are looked to for insight on new products or treatments by both HCPs and patient communities. They can play a key role in increasing awareness of new commercial and investigational products, educating their peers about when and how new products may best be used and providing a sense of credibility among both HCPs and patients.

Thought leaders generally are trusted and well-respected individuals with proven expertise in a particular field. They can include prominent physicians, hospital executives, health system directors and researchers. They also may include less well-known professionals that have close ties to a particular patient or disease community.

Digital thought leaders—who make broad use of social media platforms like LinkedIn, Twitter and others to engage with and educate HCPs and patients—are also growing in importance. These thought leaders can be particularly effective in helping to drive information to the most relevant audiences by making use of social media algorithms to reach both the broadest and most-well-targeted audiences.

Finding key thought leaders


Many developers, manufacturers and contract research organizations (CROs) have their own internal processes for maintaining information about opinion leaders that they either have tapped for expertise in the past or have been following in anticipation of seeking their help with future products. But these—typically gleaned from a variety of sources, like applications, websites or internal tracking documentation, among others—are likely to have gaps in actionable information on their thought leaders.

For companies that have not developed such an internal resource, database service providers do exist. But use of generic, one-size-fits-all database providers will likely lack the specificity needed to meet each company’s or product’s individual needs. A generic database may, for instance, fail to take into consideration the needs and nuances of a specific company’s or team’s organization, objectives and strategies. A company’s insight-gathering needs may also be dependent on a particular patient population, disease state or other factors that cannot be fully captured with a generic database service.

A customized approach is more suitable to life sciences companies that are developing a wide array or product types for a range of disease states. For instance, Panorama, a thought leader management application acquired by Pro-ficiency earlier this year as part of Compass Group Partners, includes a database that can be configured specifically for an individual company’s specific needs and organizational structure. It can be geared specifically to target and manage information on thought leaders most important a specific disease state or therapeutic area, as well as include all the elements involved in strategic thought leader engagement planning.  This negates the need for companies/team members to go to multiple data sources, as well as work in multiple documents where collaboration and version management are challenges. 

Key factors to customization


This customization is borne out of a deep dive to understand not only each organization’s information needs, but also how teams are structured and how they work together and communicate. The customized database is then structured so that the information most important to the organization is quickly and easily accessible via an intuitive, customized dashboard.

The easy-to-use dashboard allows users to easily find information based on a variety of filters, from therapeutic expertise to affiliation to geographic location. The goal is to ensure that the application is configured to make the information most important to the company readily available. This includes the ability to easily generate needed reports and any other functionality that each individual company needs.

Information on thought leaders needs to be extensive, including their specific areas of expertise, affiliations, publications and clinical trials they have conducted, if applicable.

Panorama provides customization based on a deep understanding of the company, the teams that will be using the database, what their objectives are and how progress toward those objectives is measured. Key factors in providing customization include understanding:

  • Brand or franchise objectives;
  • How the company or team is organized; and
  • The objectives and priorities for various levels of the team, which could include everything from providing updates on insights or engagement to senior management, to helping develop engagement plans with thought leaders.

And that level of customization doesn’t end with delivery of the product and training in its use. It’s equally important for sponsors to be able to modify the database over time according to business needs. Panorama is an adaptive platform, allowing end-users to add or subtract filters—such as disease state or geographical region—easily.

Panorama offers a true strategic partnership that includes ongoing support to ensure the tool can be used to its maximum capacity. This can include continual refinement of insight gathering and engagement plans and the ability to shift easily to capture evolving objectives with thought leaders, including advocacy development for commercial users.

Differing division demands


For clients that develop and/or manufacture therapies, the ability to differentiate between the needs and regulatory constraints of medical affairs and marketing teams is an important factor. Regulations for each of those efforts can be diametrically opposed. For instance, while marketing teams often develop advocates from thought leaders, medical affairs professionals are often prohibited from doing so.

Conversely, marketing is usually only allowed to talk about the approved labeling information for each individual product. Medical affairs staff, however, can be more speculative, while CROs, by their very nature, must discuss off-label exploratory uses of therapies.

This disparity means that most companies often end up using different platforms for clinical development, medical affairs and commercial marketing. But that means comprehensive information needed by each division may not be readily available.

Being able to rely on a single system or platform to access appropriate information for each of those divisions could streamline both development and marketing efforts.

Potential clinical applications


Although much work with opinion leaders is focused on commercial or near-commercial products, they can also play a role at the R&D and clinical development stages. 

Here, access to opinion leaders can boost a sponsor’s ability to accurately identify potential investigators. Some may themselves be sought-after investigators for clinical trials in their areas of expertise. Others may be experts in evaluating protocols.

Sponsors may also use thought leaders and their networks to help identify research sites with expertise in particular disease states and capacity to deliver sufficient patients from the target populations. Enrollment is always a top concern for new drug and device sponsors when developing a clinical trial protocol; being able to quickly identify sites and investigators with access to specific patient populations can avoid problems related to selecting a “wrong” site for a particular study.

For such purposes, understanding opinion leaders’ networks is especially important. Key information to be tracked can include who an expert has published papers with, where they have made presentations, where they earned their medical degree or gained a fellowship and what hospitals or universities they are affiliated with, which can highlight the degree to which they may interact with practicing physicians.

Bottom line: Access to the right thought leaders is crucial to the success of medical products. Sponsors need to not only identify opinion leaders, but also to understand what they do, where they do it and who they are connected to through their networks. Having a comprehensive, easy-to-navigate, adaptable database, like Panorama, at their fingertips will make that job much easier for them.

Visit https://www.pro-ficiency.com/panorama/ to discover how Panorama’s KOL management capabilities can help your team.

Creating Quality by Committing to Compliance in Clinical Research

In the highly regulated world of clinical research, compliance is an ongoing concern, but can be viewed as an annoying and costly item to check off a regulatory to-do list. And it can cost a great deal of money, not to mention valuable staff time, to be compliant, especially at the front end of a study.

But establishing systems to ensure compliance up front can pay off in spades, primarily by removing most of the “noise”—glitches in operational systems that can make it difficult to quickly and easily determine whether there is a problem with an investigational product or if the problem stems from a systemic issue.

At its most basic, compliance is adherence to a set of standards or regulations. In the clinical research arena, compliance involves, broadly, performance standards and safety standards, for instance. Compliance with applicable standards and regulations is necessary to create a minimally viable product.

Clinical research involves multiple parties, each with their own particular compliance responsibilities. For instance, drug and device sponsors must make investigational products in accordance with GMPs/QSR requirements, respectively, as well as meet regulatory requirements for submitting information generated during a study.

At the research site level, IRBs lay out guidelines and standards within their own communities of research sites. Sites also must adhere to strict ethical standards, requirements for specific grant-funded efforts and internal policies.

By complying with all such requirements, clinical trials are better able to ensure that they perform optimally, meet defined endpoints and deliver the investigative treatment in a safe manner, while ensuring patient safety.

Compliance vs quality


It’s impossible to discuss compliance without also considering quality; regulations and performance standards are intended, after all, to ensure a good quality product. But while the two concepts are linked, they are not the same.

Quality involves factors such as useability, durability, utility, affordability, accessibility and other things that influence how a product is experienced by the users. It’s possible to build a compliant product that is not of good quality. But without compliance. When it comes to clinical research, the notion of quality revolves around the patient experience. 

Compliance focuses on adherence to regulations and standards. Because those regulations and standards generally are written with the goal of product quality in mind, it’s harder to achieve important quality-related factors like reproducibility and consistency, without compliance.


It is, however, possible for a product or clinical trial to be compliant and still yield a poor-quality product or inadequate research in terms of those factors. This is usually due to a checklist approach to compliance.

Many in the industry tend to view compliance activities in that way, as an onerous task involving a lot of fussy checklists, paper work and documentation. In reality, compliance needs to focus on high-reliability systems that can meet all safety and other basic requirements, including patient needs. 

Without systems in place to ensure compliance with all pertinent regulations and standards, problems can occur during the trial that ultimately are more costly. These systems can include SOPs, templates, work aids and other tools that help researchers perform consistently both throughout an individual study and across multiple studies.

Noncompliance comes with costs


Noncompliance during a clinical trial can cause regulatory problems that up the cost of a clinical trial, as well as pose risks to patients and affect data quality. The time required to complete a clinical trial can be extended significantly in the face of noncompliance, whether that is regulatory, protocol deviations or amendments or other problems.

Failure to meet all regulatory requirements can delay time to new product approval. This applies to IRB requirements and other standards, as well. Addressing such problems—including finding the root cause—can add time and expense to a study. 

More than that, not all costs can be measured only in dollars and cents. Noncompliance can damage a company’s or research site’s reputation. And the ultimate cost of not following the rules in the medical field is risk to patient health and safety.

The cost of redoing something is always higher. This refers not only to money, but also to patient outcomes, regulatory or legal sanctions and corporate reputation. One of the goals of compliance should be to establish systems that allow early, accurate detection of problems, before harm comes to patients or data integrity cannot be assured.

Cutting through systemic ‘noise’


But a clinical trial built on a foundation of scrupulous compliance with all applicable regulations, policies and standards will fare much better when unexpected problems arise. Compliant systems will have redundancies and failsafes built in to help weather any disasters that may befall a study. 

One of the most important things good compliance systems provide is the ability to see when something isn’t right. If aberrant data is quickly visible, it can be addressed before serious risks to patient safety and data integrity develop.

For example, a device manufacturer that produces a stent on a limited, one-by-one basis will find it extraordinarily difficult to conduct that manufacturing within a quality system. In this sort of a system, QSR compliance and consistent manufacturing quality would be challenging. Such a company wouldn’t have anything to look back on within its compliance system to understand where the point of failure was when the inevitable problems cropped up; it would be difficult to determine if a device failure was due to an issue with the product itself or to problems in the manufacturing system.

A more systematic method of production, in compliance with the QSR, on the other hand, adds traceability into the design. And this helps clear out the extraneous noise so that any problems that occur are more likely to be completely separate from the systems.


And the ability to handle problems can be crucial during a clinical trial. For instance, many medical devices perform essential functions that affect a patient’s immediate health. If an investigational device fails, things can go south quickly and dramatically for patients. Even in areas like medical scanning or imaging, failures can mean inaccurate diagnoses and treatment paths for patients.

Under compliance systems like this, if something comes up that is wrong, it is very apparent. Without clear systems, it’s harder to see when something has gone wrong.

For example, systematic collection of data on the front end helps researchers to see aberrant or outlying data points quickly. When a problem originates in the investigational product itself, systematic deviations will appear within the compliant systems. In other words, any deviations in data can be assumed to be because of an issue with the product.

In this way, a focus on compliance can eliminate extraneous “noise” within the clinical trial system. When all the compliance underpinnings are in place, systems within the trial will work in a consistent, reliable manner. With these basics handled up-front, researchers and sponsors are then free to be more creative and more agile in responding to new challenges or needs.

Research staff must be trained to work within the established compliance systems, as well as to perform the study protocol correctly. Since different people learn in different ways, it’s important that training incorporate different senses. Simulation-based approaches, like that offered by Pro-ficiency, often do the best job of incorporating multiple learning styles while also allowing the opportunity to practice in a consequence-free environment. 

Pro-ficiency’s protocol analysis and training approaches, for instance, help take the noise out of the system by helping research staff understand clearly what has to happen and how it has to happen. 

In short, a focus on compliance from a systems approach means that researchers don’t have to think about every tiny step that is taken for every procedure or task required in a given protocol. They can, instead, focus on the central focus of the study, which must always be patient care and data quality and integrity.

Brad Stefanovic, Clinical Operations and Innovation Leader, Joins Pro-ficiency

DURHAM, N.C., October 19, 2023 – Pro-ficiency, a leading provider of simulation-based training solutions in life sciences, has appointed Brad Stefanovic to lead the organization’s clinical trial innovation efforts. As a former Clinical Operations leader, Stefanovic brings a unique perspective on challenges facing clinical study operations, including how Pro-ficiency can address those issues. In addition, as a former advocate of Pro-ficiency solutions, he can convey the power of simulation-based training solutions from his real-world experience.

“It’s unique to find a team member that has not only talked about the need for change in our profession, but has been active in driving change for years,” said Jenna Rouse, Chief Clinical Markets Officer. “His deep understanding of the challenges facing clinical study operations, combined with his passion for innovation, make him the ideal person to lead our efforts in helping clients to proactively manage risk and improve the efficiency and effectiveness of their clinical trials.”

Brad Stefanovic brings over 17 years of experience in the clinical research industry to Pro-ficiency. He has held senior leadership positions at several leading pharmaceutical companies and contract research organizations (CROs), where he has overseen all aspects of clinical trial design, execution, and management. Stefanovic is also a recognized expert in the use of simulation and modeling to improve the efficiency and effectiveness of clinical trials.

“We are delighted to welcome Brad to the Pro-ficiency team,” said Michael Raymer, CEO of Pro-ficiency. “Brad’s deep expertise spanning from clinical research through commercialization make him the ideal person to lead our efforts in bringing simulation-based training solutions to clients. We are confident that Brad will play a key role in driving client quality through his ability to bridge the gap between theory and practice.”

Stefanovic holds a PhD in Physiology from the University of the Sunshine Coast in Australia and was Alumni of the year in 2022.

About Pro-ficiency

Pro-ficiency is a leading provider of simulation-based training and compliance solutions for clinical trials. The company provides a comprehensive suite of services, anchored by their innovation in customized, virtual training simulations, training and compliance monitoring tools, and real-time data & predictive analytics. Combined with protocol optimization, process visualization tools and professional production video capabilities, Pro-ficiency achieves improved intelligence for learners and critical risk intelligence for leaders. Learn more at pro-ficiency.com.

Contact:

Collin Brooks, Marketing Manager

collin.brooks@pro-ficiency.com, +1 919.909.0420