AHM Blog

Featured Post May 8, 2018

Technology That Will Get Your Participants Talking — To Each Other

Facilitating audience engagement is a top priority at educational meetings, allowing them to network between themselves as well as with your speakers and educators....

October 17, 2017

Life sciences innovators need to approach effective data management not just as a matter of regulatory compliance, but as an opportunity to enhance their return on investment. The dynamic diversity of this industry is...

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Life sciences innovators need to approach effective data management not just as a matter of regulatory compliance, but as an opportunity to enhance their return on investment.
The dynamic diversity of this industry is what makes it such an exciting field, and the key to harnessing that productivity is connecting innovators and thought leaders with HCPs via in-person and digital meeting programs. As this process is spread out across corporations and continents, the organizers tasked with facilitating this transfer of knowledge have an enormous responsibility to capture vast amounts of data and ensure its integrity.
With responsibility for solutions at AHM, I see every day how important it is for corporations to implement a centralized and standardized process for managing this engagement data.
It is no small feat, but it is a critical one. Like the fable of the five blind men and the elephant, companies risk missing the bigger picture if they can’t see a cohesive whole, and leave themselves vulnerable to competitive as well as regulatory challenges. Without a centralized repository for collecting and curating these metrics, life sciences industry participants may be left with a fragmented picture of their initiatives and expenditures.
A primary driver is compliance — different countries have different reporting requirements around interactions in which a transfer of value takes place (and different parameters for defining those values!), and companies have their own internal protocols, which may differ by regions, by divisions, and even by the departments that participate in procurement, facilitation, logistics, and other steps along the way.
Efficient and accurate data management isn’t just important for reducing compliance risk, it is also critical in assuring effective marketing activities. Without these data insights providing information on current activity results, the life sciences industry has no way to develop and improve on best practices. The sum is greater than the whole of its parts, if you will.
Thanks to its robust data and tools — including CentrisDirect™, AHM’s global solution to manage compliance — AHM has a uniquely data-driven view into the trends surrounding HCP engagement and program management. Look for near term announcements as AHM continues to help our customers with solutions to make business processes more effective.


Contributed by:


Susan Hill, SVP, Global Products & Solutions, AHM

Susan joined AHM in June of 2013 and is responsible for the oversight and management of AHM’s Global Business Development and Solutions and Marketing team. With over nineteen years of experience in the Life Science industry, Susan brings experience in business development, product marketing, and new technology investment and optimization.

September 28, 2017

Millennials, a.k.a. Generation Y, are moving into a position of prominence in the workforce: According to the Pew Research Center, they became the largest share of the American workforce in 2015 — and the...

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Millennials, a.k.a. Generation Y, are moving into a position of prominence in the workforce: According to the Pew Research Center, they became the largest share of the American workforce in 2015 — and the fields of healthcare and life sciences are no exception to this trend.
If this challenging and dynamic population isn’t already on your radar, it should be. Millennials, which are roughly defined as people born between the late 1970s and around the turn of the century, have some key hallmarks that shape how they acquire and absorb educational content and other information.
For one thing, they’re the first generation of digital natives. As such, millennials have notoriously short attention spans — they’re primed to absorb bombardment from snippets of information coming at them from every direction, but they can “check out” easily if a topic doesn’t hold their interest.
Growing up with Google at their fingertips, millennials have a looser view of authority and hierarchy than previous generations. They are knowledge-hungry and crave resources to acquire knowledge on their own, but they also value the advice of experts — provided that these authority figures first earn their trust.
A study on millennials in the workforce found that credibility and authenticity are incredibly important factors for engaging this generation. These are qualities that Key Opinion Leaders (KOLs) need to emphasize if they want millennials to be receptive to their message.
More so than the Baby Boomers who preceded them, millennials want the companies they interact with to have a mission and purpose. They need a narrative that articulates not only the company’s value proposition, but their own unique role to play.
All of these quirks have profound implications for meeting and event organizers.
Despite the fact that AHM data finds virtual and tele-meetings combined made up just 15% of promotional speaker programs targeting healthcare professionals (HCPs) last year, this generation’s propensity for technology — not as a substitute, but a supplement — to in-person learning means organizers should think twice before abandoning the format. Millennials love having options, so the more touch points you can provide them with, the better; this is the generation, after all, that grew up with hundreds of options just for ordering a morning coffee.
The rise of venue-based meetings — up nearly 20 percentage points between 2014 and last year, AHM found — dovetails with another preference near and dear to millennial hearts: Collaboration. This is a population that loves to work in groups and pool knowledge. Surveys of millennial doctors found that these HCPs believe their peers to be a valuable educational resource — something to keep in mind when designing program content and even when targeting KOLs to reach a millennial audience.
The path to engagement with millennial HCPs may not be as straightforward as it was with their parents, but this generation’s eagerness to learn, willingness to embrace new technologies and openness to collaborative knowledge-seeking gives the industry the chance to build a deeper, more direct bond with this rising population of HCPs.
Source:
http://www.pewresearch.org/fact-tank/2015/05/11/millennials-surpass-gen-xers-as-the-largest-generation-in-u-s-labor-force/
AHM Research


Contributed by:


Susan Hill, SVP, Global Products & Solutions, AHM

Susan joined AHM in June of 2013 and is responsible for the oversight and management of AHM’s Global Business Development and Solutions and Marketing team. With over nineteen years of experience in the Life Science industry, Susan brings experience in business development, product marketing, and new technology investment and optimization.

July 12, 2017

Technology Is Essential Compliance officers indicate that technology and analytics are the elements to successful healthcare professional (HCP) transfer of value interactions, spend compliance processes, and overall HCP engagement management. Modern automation allows for...

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Technology Is Essential
Compliance officers indicate that technology and analytics are the elements to successful healthcare professional (HCP) transfer of value interactions, spend compliance processes, and overall HCP engagement management. Modern automation allows for both consistency and compliance with HCP interactions; however, technology alone does not solve every single challenge that arises with policies and procedures. It’s best practice to consider technology throughout the project-process life cycle with the understanding that technology will be the main enabler.
Partnership Paves the Way
How can Life Sciences organizations acquire and maximize technology to efficiently and accurately collect data, ensure compliance, reduce risk, and consolidate redundant systems? Well, they can start by searching for and partnering with a trusted technology advisor and ensuring that this partner is seated at the table for these important decisions. This advisor may be an internal employee, a trusted consultant, or vendor partner. Second, the organization should recognize that this is a long-term relationship—from ramp up, to implementation, to steady-state—there should be ongoing support, collaboration, and communication throughout the lifecycle and/or program. Third, the organization needs to understand the vendor’s approach to the product and/or platform.
Capabilities Are Key
Shopping for any technology, be it smart phone, laptop, or robust platform suite, entails a comparison of capabilities, features, customization, pros and cons, trial runs, and users’ experiences/reviews, among other aspects. When evaluating vendors’ technologic capabilities as it relates to capturing HCP engagements, consider the following:

  • If this is a baseline technologic product, understand its current capabilities and the vendor’s future roadmap
  • If straying from the baseline technologic product, ensure the vendor is willing to configure to the organization’s needs and what related costs and/or impact might be
  • Develop the requirements and map to baseline; identify gaps and assess costs and/or ability to customize
    • Know there may be features available that are not part of current requirements; keep an open mind as these features may enhance the organization’s business processes
    • Request a detailed walk-through and product demonstration to identify these opportunities
  • Consider vendors’ capabilities for post-implementation ongoing support and enhancements
  • Gather inputs from past experiences and industry colleagues

Taking the necessary time to explore technologic platform offerings, features, and capabilities can help Life Sciences organizations remain compliant, organized, and well equipped for the path ahead, and also realize a return on their technologic investment.
AHM is a leading global provider of software and service solutions designed to manage compliant interactions with HCPs for the Life Sciences industry. For more information about AHM’s full suite of support services, please visit: http://www.ahmdirect.com or email info@ahmdirect.com.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

June 29, 2017

Once upon a not too distant time, a well-known UK-based Life Sciences manufacturer was looking to engage a different vendor partner—one that had the technologic offerings and know-how to assist with collection of healthcare...

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Once upon a not too distant time, a well-known UK-based Life Sciences manufacturer was looking to engage a different vendor partner—one that had the technologic offerings and know-how to assist with collection of healthcare professional (HCP) transfer of value interactions, spend compliance processes, and overall HCP engagement management. After meeting various candidate companies, the manufacturer ultimately selected AHM as the preferred vendor partner. What were the key differentiators that solidified this partnership? Technology, for starters. The manufacturer was intrigued by CentrisDirect, which is a state-of-the-art compliance platform suite to collect and consolidate all HCP transfer of value interactions across the enterprise. The other key differentiators included HCP management expertise, dedicated customer service, and proclivity toward ongoing collaboration.
What’s the vitality of this partnership today? According to the Life Sciences manufacturer, field sales representatives “love the vendor’s app” and the technology allows for consolidation of redundant systems and vendors. In addition, the collaboration is highly valued because of the consultation services offered by the vendor. Among the implementation highlights are process-driven and solution-oriented teamwork. The vendor partner is “quick to add planners, when necessary, and provide a flexible solution that allows for configuration of new program types” and “is huge in generating an employee training package.”
Notably, as a result of this partnership, the Vice President of Sales no longer receives escalations for non-compliance issues. So, what are the ingredients to a successful union? Akin to any partnership, expertise, proactivity, trust, organization, collaboration, communication, and education figure prominently. According to the manufacturer, successes were realized, in part, because of the following:

  • Central Operations requested that key stakeholders step back from solution-seeking and rely on the vendor partner to bring its technology and process expertise to develop solutions for them
  • Compliance was integral in the implementation of the core team, and therefore, trusting of decisions made and the end results from the vendor partner
  • A core team was established that represented all key stakeholders and accountability for each discipline, that is, Central Operations, Information Technology, and Compliance
  • Ongoing communication plans with the field force were established and maintained
    • Publish overarching plan and timelines with checkpoint communications along the way
    • Involve the field force in User Acceptance Testing to ensure technology accounts for both sophisticated and less savvy users
    • Establish champion districts or leaders to check in with on a routine basis and establish district rounds for feedback from others
    • Expedite contracting by convening all parties to the table at once; in this case the process was extended until this was completed
  • Provide a comprehensive training package
    • Training Managers are key to further support/assist the field
    • Establish a follow-up training plan to check back in with the field several weeks after launch for feedback and to make refinements
    • Reiterate/highlight key compliance points or changes
    • Provide best practices to guide implementation and best use of the Business Rules compliance engine, CentrisDirect

AHM is a leading global provider of software and service solutions designed to manage compliant interactions with HCPs for the Life Sciences industry. For more information about AHM’s Solution Portfolio, please visit: http://www.ahmdirect.com or email info@ahmdirect.com.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

April 13, 2017

Do you know that a day in the life of a meeting professional has a lot to do with alphabet soup? Those that work in and service the life sciences industry are very used...

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Do you know that a day in the life of a meeting professional has a lot to do with alphabet soup?
Those that work in and service the life sciences industry are very used to working with and speaking in acronyms; a kind of endless alphabet soup. Some acronyms are our very own, others are critical to the Life Sciences industry and corporate language more generally. Sometimes acronyms can be annoying but most of the time they save us a mouth full of words and a lot of time. A case in point is new acronym which doesn’t exactly roll off the tongue: IPERP.
What’s that you say? Well, IPERP is shorthand for a very handy mantra that describes what Life Sciences meeting professionals need to manage, constantly: Initiate, Plan, Execute, Report (and Pay!). In action, this is what IPERP looks like…
Initiate — Most meetings have budget constraints, regardless of size, and attendee or meeting type. It is important to define a business purpose or goal prior to commencing the planning. This Initiate phase is critically important when hosting or sponsoring a meeting with one or more Healthcare Professionals (HCPs) in attendance. The rationale for engaging an HCP for any activity is highly scrutinized and must meet the necessary criteria in accordance with local and/or federal government regulations in addition to one’s own organizational guidelines and policies.
Life Sciences companies incorporate an internal approval process as a first step when looking to hold a meeting or event to ensure these interactions or series of engagements comply with all of these policies and guidelines as well as to meet the goals and budget of the program itself.
Companies use off the shelf products or technology to begin this process or may even use a paper form that gets routed for signatures according to signing authority. Having a system or compliance platform to capture the business rationale, list of HCPs, and the budget and goals of the meeting will certainly expedite the approval process. This is also a necessary part of documenting and archiving everything that was done to ensure proper steps were followed. And this must be accomplished and approved prior to the HCP being invited or even contracted.
These paper forms or Meeting Request Forms (MRF), yet another acronym, can take some time to get approved as it makes its way to the proper stakeholders and approvers. Some organizations require multiple approvals and the extra time this requires can leave planner with a very short time to actually accomplish the needed tasks. If something is out of line or out of policy, the request should not be approved until the proper review is conducted or until changes are made to support the relevant policy. While a meeting professional is waiting for the green light to move forward, a proactive approach can be taken by putting a detailed timeline together to ensure the planning team is ready to go once the meeting has been approved.
Plan — Establishing the right foundation with your client during this time is vital to success. Ask key questions of your client or sponsor and review details and expectations with their compliance representative. Determining needs prior to the planning phase will assist in ensuring a successful event and will guarantee that the specific data they need is captured, tracked, and reported on. Once initiation is approved, you are able to plan the event or program, registration can go live and travel can be issued for all meeting attendees, where applicable. Further details in the planning process are now being managed such as the main components of F & B (Food & beverage) AV (Audio-Visual) meeting APP set up, meeting rooms set… and the rest of the familiar “laundry list” that planners know well.
F&B planning sounds easy and fun, but only if you have a calculator handy. Meal caps need to be carefully considered when a HCP is in attendance. Costs per meal cannot exceed the cap per person an organization has agreed to and if/when an attendee is from another country, that country’s meal caps must also be adhered to. Working closely with your hotel partner to come up with a menu that is robust, with plenty of items that fit the needs of all attendees, including special dietary restrictions (kosher, vegetarian, halal, gluten free & food allergies.) is in itself a major task. But it must also fit within the constraints of governing law. It is helpful to start the conversation with your hotel partners early as well as building this into your meeting contract & addendum with the hotel to ensure they can accommodate the caps as well as other needs.
Execute — It ain’t over til it is over….Once on site at the meeting making sure that what you have planned for is actually happening is of critical importance. Deviations from the contracts, meal caps or other activities outlined and approved in your Initiation and planning phase can result in compliance violations and subsequent penalties. While on site, among managing your multiple tasks, various changes and still delivering service with a smile, it’s essential to meet with the hotel and other vendors to review costs daily to make certain the data is correct . This is not only good management but it is vital to the transfer of value (ToV) reporting requirements.
Report & Pay — Once you execute the meeting successfully it’s time to wrap it all up. We all know that many clients want to receive the ToV reporting in different ways. It is best to continuously have a conversation with your client to ensure that you’re using the most up to date method of data capture and the preferred reporting format. Reviewing and submitting all meeting related invoices as well as attendee honorarium and expenses in a timely matter for payment will help expedite the reporting and close out process. It also helps to catch any discrepancies in costs or associated expenditure.
That’s IPERP! Add this acronym to your list and introduce it and include the categories in your team training. This can help create efficiencies, ease and overall best practices! Of course, an additional acronym comes to mind in closing this blog and one that is a favorite — KISS. Keep It Simple Silly!

Contributed by:


Matthew Derner, Director, Strategic Meetings Management, AHM

Matthew joined AHM in 2016 and has 18 years of Life Sciences experience. He leads AHM’s Stragetic Meetings Management (SMM) Department and is responsible for engaging current and prospective clients about our SMM compliant meeting solutions across their organizations. Matthew also leads a team of Event Managers & Coordinators that are responsible for the planning and execution of any meeting type outside of Speaker Bureau. Prior to joining AHM, Matthew has worked for Pharmaceutical Companies as well meeting planning agencies in various roles.

March 22, 2017

Neither snow nor rain nor heat nor gloom of night stays these couriers from the swift completion of their appointed rounds” — This slogan came to mind during the 13th Annual Pharmaceutical Forum co-hosted...

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Neither snow nor rain nor heat nor gloom of night stays these couriers from the swift completion of their appointed rounds” —
This slogan came to mind during the 13th Annual Pharmaceutical Forum co-hosted by Meetingsnet (@meetingsnet) and CBI, Center for Business Intelligence (@CBI_Conferences) held in Baltimore, Maryland. As winter storm Stella was moving into the area and threatening attendance, I sat wide-eyed in anticipation of the Opening Session where I witnessed the arrival of over 800 attendees, a 27% increase in corporate planners and 20% increase in international attendance from 2016.
Sitting tall and attentive with super-cool meeting analytics devices in hand provided by Educational Measures (@EdMeasures); junior and senior meeting professionals, hoteliers and 3rd party vendors embraced the theme of the conference:

[one_third last=”no” class=”” id=”]Educate[/one_third][one_third last=”no” class=”” id=””]Engage[/one_third][one_third last=”yes” class=”” id=””]Empower[/one_third]

Over three days of general sessions, educational breakouts, and networking events, attendance stayed strong. Committed to completing their appointed rounds…stakeholders in attendance continued to coach one another on best practices, engage in problem solving and empower one another to convey success stories that can assist each organization with addressing the challenges of managing HCP interactions. Based on what I saw and experienced I have chosen to add what I believe was a fourth theme at the conference; and that is Enlighten. For example, one of the opening sessions titled Navigate Meeting Management in a World Full of Risk poignantly illustrated the current world in which we now live and work. The slides referenced the fact that Risk Management is the fastest growing career today and that 48% of meeting professionals surveyed reported an increase in their meeting costs because of the need for increased security — up from 17 % in 2015.
In addition to compliantly managing HCP engagements and managing overall risk, globalization is on everyone’s mind, regardless of which side of the desk you are on. Life Sciences organizations strive to align their processes and centralize data across their organizations through global Strategic Meeting Management Programs (SMMP). During the keynote address, Shaping Our Future — Execute Successful Global Programs and Expand Business Interests Based on 2017 Industry Trends — we were reminded of the critical success factors that must be in place when creating and launching an SMMP. These success factors include strategy governance and policy, change management strategy, the RIGHT resources and near and dear AHM, of course, a global technology platform. Vendors and third parties are aligning globally to provide trusted advice and solutions that drive efficiencies and cost savings while easing the adherence to compliance requirements. Best practices and the pitfalls of designing an SMMP will be further identified in AHM’s soon to be released whitepaper on SMMP.
In reflecting on the overall conference and experiences shared this year, the true value of face-to-face meetings comes to mind. Another statistic highlighted by Meetings Mean Business (@MeetingsMeanBiz) is the fact that 1 hour of face-to-face contact equals to 5 video conferences, 10 phone calls, or 20 emails! Although virtual meetings or a component within your live meetings adds value, nothing can replace the human face-to-face element. It remains the key to building important and lasting relationships.
I attend this conference every year and look forward to doing so in the future. Peers, competitors, colleagues are there and yes — friends are there! Thank you to contributors, and all of the attendees @pharmaforum_cbi. See you next year!

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

March 1, 2017

Healthcare Professional (HCP) Perspectives As noted in Part 1 and Part 2 blogs in this series, successful compliance ultimately involves everyone in the organization and also includes engaging HCPs in the process. Everyone has...

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Healthcare Professional (HCP) Perspectives
As noted in Part 1 and Part 2 blogs in this series, successful compliance ultimately involves everyone in the organization and also includes engaging HCPs in the process. Everyone has the responsibility for doing the right thing, and organizational culture must support and strengthen this process. Operational checklists and audit practices are all important, along with a universal understanding of what is meant by compliance. Everyone that compliance touches should be ready to step up and do their part to ensure success.
Consider that the average length of time it takes to develop a new medicine or product ranges from 10 to 15 years. During this time, Life Sciences employees in many areas interact with HCPs. Throughout this interval, each organization needs to ensure that every action and interaction is compliant across state, federal, and even international regulations, as well as internal corporate guidelines and SOPs. The expectation that everyone is responsible for ethical practices and standards begs the question: How can HCPs contribute to increased success with compliance for an organization while simultaneously focusing on patient needs? At AHM’s Annual Industry Conference, our HCP panelists commented on this very question. Some of their suggestions included:

  • “Just make complying easier!”
  • “We need time with our patients, we need time in the office, we need time to keep abreast of cutting edge therapies—you need to make dealing with industry less cumbersome.”

We recommend that Life Science organizations start by communicating the compliance process to HCP in a clear, concise, and continuous manner. This should include providing any rules or policies around reporting or exceptions to the process. The feedback that AHM received implies that this is still not adequately addressed. When all parties are engaged and informed, a solid relationship is built between the parties, and the credibility of the organization is increased. HCPs long to be communicated to correctly and clearly. To make their experience less confusing and burdensome, they would like to have the same experiences regardless of what activity or who in the organization they are working with. Since the Open Payments Act was established, HCPs and their relationships with industry are reportable, thereby providing greater transparency into financial transfers of value in categories of honoraria, and travel and meal costs associated with speaking or consulting. HCPs contribute to compliance by understanding the policies of the organizations they interact with. Moreover, HCPs have welcomed the communication necessary to inform the public on their role in the drug/device development process and how it impacts patients and their care.
HCPs partner with industry to achieve their primary goal, patient care; however, the process can be further improved so that compliance obstacles do not stand in the way.
AHM has a suite of end-to-end single-platform solutions to meet the compliance needs of Life Sciences organizations and HCPs. These capabilities can smooth compliance for HCPs and help them become a valuable partner in the process. For more information, please visit: http://www.ahmdirect.com/.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

February 15, 2017

Introduction In the Life Sciences industry, many organizations utilize third parties and multiple vendors to assist with compliance. Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* revealed...

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Introduction
In the Life Sciences industry, many organizations utilize third parties and multiple vendors to assist with compliance. Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* revealed that 56% of the respondent organizations use a hybrid model of some internal departments and some outsourced to other third party vendors.
The third party or vendor is a critical component in the success of the compliance process. This blog aims to help the Life Sciences industry not only understand the role of the third party but also to provide recommendations on ways to best work with third parties and vendors in assisting organizations with their compliance processes.
*The full study is available here.
What Unique Perspective Can the Third Party or Vendor Provide?
A third party or vendor brings a unique perspective regarding compliance to their clients due to the very nature of working with multiple clients, each with a different process, policy, and interpretation of various state, federal, and international guidelines. This unique perspective can provide valuable guidance, benchmarking, and business intelligence, which often increases trust and credibility in the third party. It allows the third party to position themselves as a trusted advisor and leader in the Life Sciences industry. Third parties and vendors can lead the discussion on compliance at industry educational events and serve as thought leaders and subject matter experts in compliance.
What Are the Challenges to the Third Party or Vendor?
There are challenges that the third party or vendor confronts as organizations outsource the various components of the compliance process. In Part 1 of this blog series we highlighted that:

  • 72% of respondents indicated multiple, disparate systems for the capture and reporting of data was their biggest problem. This, too, is a challenge for the third-party or vendor. Often they must navigate multiple systems for the approval process, including collection of healthcare professional (HCP) spending and for reporting purposes.
  • 48% of respondents indicated multiple vendors handling their tracking and reporting of HCP data was a challenge. Third parties are also challenged in working with different vendors in which the processes and knowledge of policy and client interpretation may be different.

Additional challenges may include:

  • An increase in the number of clients asking third parties or vendors to have a financial stake in the accuracy and timeliness of data being entered and reported. This may cause friction in the relationship if the expectation was not set initially or may add additional risk to the third party.
  • Condensed timeframes required to collect and report accurate data, which causes undue stress and pressure and can lead to errors and unforeseen budget increases.
  • Data provided by the various vendors may not be consistent in format or organized in a manner that is easily transcribed or uploaded into multiple systems. This may result in additional fees or increased staff hours that were not anticipated or allocated in the approved budget.
  • HCP dissatisfaction towards the third party or vendor due to lack in communication or clear process/policy from the client.

Mitigating the Risk to Their Client—How Can They Help?
As an organization is selecting a third party or vendor to assist with compliance, keep in mind that third parties and vendors often need to adjust quickly to meet or exceed client expectations. A successful working relationship between client and vendor includes honest, open feedback as well as expectation and goal setting at the beginning of a project. Success in assisting the client with compliance begins with identifying and understanding the key stakeholders and parties. As mentioned in Part 1 of this blog series, different organizations place the responsibility of compliance in various business units and parts of the organization. Each organization needs to determine what is best for it. The third party or vendor will have the most success when they have a firm grasp on the organization’s process, policy, and key players. Following are a few recommendations and qualities to look for when selecting the right third party or vendor for compliance needs.
The third part or vendor:

  • Keeps abreast on all industry regulations, including local and global compliance regulations, and cultivates on-staff subject matter experts in compliance process and policy.
  • Attends industry education, speaking engagements, business intelligence reporting, and benchmarking to continually provide innovative solutions and proactive ideas for Life Sciences organizations’ compliance reporting and analysis needs.
  • Participates in regular meetings with key stakeholders regarding compliance, and serves as a resource to internal staff and key stakeholders.
  • Provides multiple technology and service solutions to meet the organization’s end-to-end compliance needs including approvals, transfer of value data, and reporting capabilities.
  • Aligns their goals and objectives regarding compliance with the organization, understands the corporate culture, and customizes solutions to meet the organization’s needs.

AHM has a suite of end-to-end single-platform solutions to help ensure organizations are compliant in all HCP interactions. For more information, please visit: http://www.ahmdirect.com/.
Next Steps
Check back in at AHM Voice to read Part 3 in this series, which will look at the perspectives on compliance from the HCP (physician), and how HCPs can contribute to successful compliance for an organization while simultaneously focusing on patient needs.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

February 2, 2017

Introduction There are multiple departments, business units, vendors, and stakeholders involved in Life Sciences compliance and the Open Payments process. With the multitude of moving parts, it is common to experience challenges in reporting,...

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Introduction
There are multiple departments, business units, vendors, and stakeholders involved in Life Sciences compliance and the Open Payments process. With the multitude of moving parts, it is common to experience challenges in reporting, timeliness, and accuracy of these data. Moreover, there are challenges with communication to healthcare professionals (HCPs) and the various players involved in this process. This blog series is intended to identify the various perspectives involved in defining challenges and issues and to provide potential discussion points and solutions for the reader.
What Are the Challenges to a Life Sciences Organization?
Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* illuminated the following:

  • More than 40% of respondents said compliance was the greatest challenge at their organization; and
  • 82% of respondents said increasing compliance was the most important HCP engagement initiative.

Several key challenges to more successful compliance management surfaced, including:

  • 72% noted multiple, disparate systems for the capture and reporting of data was their biggest problem;
  • 48% indicated multiple vendors handling their tracking and reporting of HCP data was a challenge;
  • 43% of respondents reported HCP data accuracy was a challenge; and
  • 42% of respondents cited lack of internal and external resources to handle data tracking and reporting as a challenge.

*The full study is available here.
Compliance Within the Life Sciences Organization
Across the Life Sciences industry, the primary purpose of any organization is to deliver quality patient care and/or healthcare solutions for patients. Clinicians, scientists, and other employees strive to bring innovative products to market that will benefit patients across the age spectrum. Compliance drives many of the decisions in developing new products. There are a host of laws, best practices, and guidelines associated with drug/device development and commercialization, such as clinical regulatory compliance, legal compliance associated with anti-bribery, anti-kickback laws, and ethical accounting practice statutes, among many others. Employees across the Life Sciences organization may find themselves saying, “I am not a compliance officer; my job is ‘X’ or my responsibility is ‘Y’ and has nothing to do with a regulations or a compliance program.”
Yet the expectation is or should be that everyone has the responsibility for doing the right thing. Organizations must create a culture whereby each employee upholds the highest ethical and professional standard as general practice. Several industry leaders’ mantra is to have a thorough and robust compliance program addressing the myriad of risks associated with bringing new products to market. Yet it must also be one that promotes ease of adherence. Processes, operational checklists, and audit practices are all necessary but there needs to be a universal definition of compliance instead of a fragmented description. Leaders driving compliance are really seeking employees to create and embrace an ethical barometer. They must ask themselves not only, “Can I do it?” but “Should I do it?” Once that is answered, the how needs to be easy, trackable, and monitored.
What Can a Life Sciences Organization Do to Improve Compliance?
Any good compliance program at a Life Science organization starts with key stakeholder identification. Different organizations place the responsibility of compliance in various business units and parts of the organization. Each organization needs to determine what is best for it. Some organizations handle this internally whereas others outsource this task to a third party. It doesn’t matter who handles it as long as they have a firm understanding of the organization’s needs and a process for the accurate and timely capture and reporting of the data. Based on AHM’s experience, we recommend the following:

  1. As your organization begins to analyze its compliance process to ensure accurate and timely reporting, it is crucial to identify all the parties involved and their level of commitment and expectations. Various departments may include: legal, compliance, medical affairs, meeting management services, accounting, the compliance officer, and administration.
  2. Schedule regular meetings with all parties involved to discuss the objectives, process and timeline for adhering to SOPs and reporting requirements to ensure understanding and expectations.
  3. Ensure that each vendor understands your internal compliance, data collection, and reporting requirements so they adhere to processes and provide the data in a format you can understand and use.
  4. Continually communicate the process to the HCP in a clear and concise manner, including any rules or policies on interactions with your organization and reporting or exceptions to the data collection process. When all parties are engaged and informed, a better relationship is built between the parties and the credibility of the organization is increased.

Once the organization has identified the key players and compliance goals and objectives, the right vendors and external resources can be instituted to ensure data on compliant HCP interactions are collected and reported in an accurate and timely manner.
Next Steps
Check back in at AHM Voice to read Part 2 in this series, which will look at the perspective of the third party or vendor to identify challenges and recommend solutions for improving the compliance process.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

January 18, 2017

Global Dilemma: Determining Healthcare Professional (HCP) Eligibility For Life Sciences manufacturers, HCP interactions are a BIG DEAL. It takes many months of researching, planning, scheduling, recruiting, tracking, and corresponding with a variety of stakeholders...

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Disclaimer


Global Dilemma: Determining Healthcare Professional (HCP) Eligibility
For Life Sciences manufacturers, HCP interactions are a BIG DEAL. It takes many months of researching, planning, scheduling, recruiting, tracking, and corresponding with a variety of stakeholders to engage the right speakers and participants. HCP interactions are critical to healthcare organizations (HCOs) because of the exchange of scientific and medical information, and candid feedback that is integrated into research and key opinion leader input. One compliance dilemma AHM has assisted their clients with over the past few years centers on participant eligibility. This dilemma is not limited to the United States—increased programming in global markets, such as those in European and Asian-Pacific regions, entails participant recruitment from other countries around the world, different sets of rules on how HCP interactions can occur, country- and/or institution-specific regulations, and variances in transfer-of-value reporting requirements, among other challenges. Coinciding with global HCP interactions are the complexities of complying with global regulations when managing HCP interactions.
Compliance violations due to participant ineligibility trigger retrospective inquiries: Were the right HCPs invited to attend the promotional or nonpromotional event? Were the right speakers invited and qualified to present at the meeting? What are the rules that govern how interactions can occur with each and every HCP? According to Frank Castora, Director, Global Solutions Management at AHM, planning future HCP interactions prompts several questions such as: Is there a way prevent the “accidental attendee” and consequent compliance violations? What can Life Sciences manufacturers do to be proactive and prevent this increasingly prevalent global dilemma?
Global Solutions: CentrisDirect Release 2 and Strategic Alliance
Global dilemmas require global solutions. AHM is a leading global provider of software and service solutions designed to manage compliant interactions with HCPs and Life Sciences industry. To address the pressing compliance requirements and dilemmas when managing global HCP interactions, AHM upgraded CentrisDirect, which is the company’s single end-to-end cloud-based platform suite designed to collect and consolidate all HCP transfer of value interactions across the enterprise. Enhancements to the platform, called “Release 2,” are available now and have generated significant market interest both domestically and internationally. The platform enhancements were specifically designed to prevent and address complex global compliance dilemmas. Some of the enhanced features include:
Product Localization

  • Platform translated into simplified Chinese and Portuguese

Enhanced Compliance Controls

  • Identify participant eligibility issues during closeout
  • Identify and track compliance violations for interactions
  • Exclude ineligible HCPs from participating in an interaction
  • Leverage Compliance Violation Tracking if a violation transpires

Speaker Utilization Caps

  • Select speakers aligned to their territory per specific number of times during a specified interval

Interaction Compliance Audits

  • Flag an interaction for Compliance review

Marketing Initiatives

  • Configure a set of interactions with a common set of parameters and/or business rules (eg, program type, budget, speaker count, and topics)

Interaction Change Requests

  • Modify an approved HCP interaction or cancel an approved interaction

HCO Interactions/Contracting

  • Support institution-based workflow in a mobile platform
  • Contract with an HCO

To complement their global support and solutions, AHM has partnered with Veeva Systems, Inc., for integrated events management and compliance solutions for events management. This strategic alliance provides additional opportunities for customers by integrating CentrisDirect with Veeva CRM Events Management into a single platform to manage HCP/HCO interactions and to ensure global compliance requirements are met.
AHM to Present Global Compliance Solutions at the Speaker Programs 2017 Conference in Philadelphia, PA
Hear AHM’s Frank Castora discuss Strategies/Technologies for Managing Compliant Promotional Programs Globally at the Speaker Programs 2017 — Evolving Considerations for Innovative Promotional Programs, February 8-9, 2017, at the Wyndham Philadelphia Historic District hotel. Mr. Castora’s presentation, which is scheduled for Wednesday, February 8th at 3:45 PM, will focus on:

  • Solutions for managing organizations’ marketing initiatives and tracking to ensure compliance with international regulations and organizational SOPs;
  • Key process areas to ensure cap utilization and HCP participant eligibility; and
  • How the configuration of compliance rules and systematic prevention can detect, capture, and manage participant compliance violations.

While you’re at Speaker Programs 2017, don’t forget to check out AHM’s booth, which will feature live product demos. Conference registration and additional information are available here. For more information about CentrisDirect Release 2, email info@ahmdirection.com.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.