Success Story: Implementing VALTs On-Demand Training to Maximize ROI


A face-to-face investigator meeting implemented VALTs, our on-demand training option, on the spot to enhance the training experience for their current and future study sites. VALTs is our Virtual Assessment Learning and Training platform used for the purpose of deploying on-demand training at the ready when needed.

The Challenge

The sponsor company had a complicated study product processing and handling scenario. Within the first hour after the face-to-face investigator meeting (IM) had started, the sponsor decided they wanted to implement MTA’s VALTs Virtual Assessment Learning and Training Source in order to offer on-demand training to their attendees after the meeting had concluded. Offering on-demand training has many benefits, and the sponsor wanted to maximize the training capability to best serve its audience.

The Solution

MTA’s audiovisual team immediately began to audio capture the remainder of the investigator meeting to repurpose the training content. Following the conclusion of the meeting, MTA went on-site to the sponsor company’s offices and video-captured the subject matter expert’s presentation of the study product (remote-capture is also an option if needed). Once the video portion was captured, an audio presentation was completed and edited into the training video/s.


This training that was captured was used to create a catalog within our VALTs platform. The training is now used to train new sites being added to the study or as a training refresher for when new study product shipments are received. In addition, this client has a specific reference manual that is referred to in the catalog; each time the reference manual requires an update, the VALTs catalog is also updated, so that the material is always current when sites need to use it as a reference.

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Want to learn more about how VALTs can maximize your study site training? Reach out to our team to learn more!

Investigator Meetings: Compliance Q & A

Chief Compliance Officer Mary Long at Miller Tanner Associates (MTA) shares with us the challenges and best practices for addressing compliance when planning investigator meetings (IM).

Frequently Asked Questions About Compliance When Planning an Investigator Meeting

What needs to be considered to approach compliance comprehensively when it comes to investigator meetings?

When initiating plans to conduct an investigator meeting, reviewing the hospitality sections of the Manufacturers Associations’ country codes of conduct along with the sponsor’s hospitality guidelines (if provided) are essential. 

What is currently the biggest challenge for pharma companies regarding compliance and investigator meetings? 

One challenge for the pharmaceutical industry is the sites’ overall learning plans for compliance with the investigational study. One way to overcome this challenge is to approach investigator meetings with highly-focused agendas and interactive sessions that dovetail with the overall learning plan for the conduct of the study.

How does Miller Tanner assist our clients with ensuring compliance for their IM?

MTA provides our team with written communication of any specific client’s guidelines on file,  coupled with the applicable country codes related to appropriate interactions with healthcare professionals as used by the industry.  The team reviews guidelines early on in the preparations of an event and follows the guidelines to assure compliance.

Related: Meet Mary Long

What are some resources for compliance information for clients?

Helpful resources for review are the country codes of conduct, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and European Federation of Pharmaceutical Industries and Associations (EFPIA).

What are some important agenda items that must be considered for all investigator meeting planning? 

Create “focused” agendas that provide interactive sessions to enhance learning opportunities and engagement with the sponsor and sites.  Remove agenda items that are redundant or that will be gained by different avenues.

If you’d like to learn more about how MTA ensures compliance throughout your meetings, visit our blog Transparency Reporting for Hospitality Made Easy.

If you need help with planning an Investigator Meeting, contact us online or call 877.726.3129 

Investigator Meetings: Maximize Your Training Strategy

How tomaximize your investigator meeting strategy

Training, continuity in training messages, and documentation of training are all critical components of a successful clinical study.  The pharmaceutical industry invests significant spending in monies and resources to develop a molecule and to document the training of investigator site personnel regarding the clinical research study as is required by agencies such as FDA, EMA, PMDA, etc. With so much invested, Miller Tanner asks,  your training strategy ensuring success?

Is your training approach a “one-shot-and-done” or “holistic”?

Investigator meetings usually include two people from each site to attend due to the costs associated.  Those two attendees are expected to go back and train others.  Sometimes as a follow-up, each site may receive a Site Initiation Visit (SIV) which includes training on the protocol and investigational plan from a monitor/CRA before the site starts enrollment.  Often that concludes the site training.  We know that sometimes the “one-shot-and-done” approach works and other times not so much.

Investigator meetings are still a good investment.  Time and time again, follow-up surveys from the sites state that face-to-face time with the pharma company, medical scientists, and colleagues goes a long way to provide continuity in training messages, and networking to assist in best practices and to gain enthusiasm about the research. But we know change happens. How will you manage the study when change occurs? How will you handle protocol amendments?  Do you share best practices across your sites?  How will you account for attrition?

Although face-to-face investigator meetings are an integral part of the training process, in some circumstances it may not be enough. A “holistic” training plan provides many additional tools and methods that can be deployed over the course of an investigational study using virtual and hybrid options combined with our e-learning platform, VALTs.

To discuss a broader, “holistic” approach for training solutions, contact Miller Tanner Associates today. We can help you get the most out of your investigational study.

Best Practices: Inviting South Korea Healthcare Professionals to Event Training

South Korea Event Best Practices

South Korea’s Improper Solicitation and Graft Act

About a year ago, the meeting industry was made aware of South Korea’s Improper Solicitation and Graft Act (subsequently referred to as the “Act”).  “The purpose of this Act is to ensure that public officials and relevant persons fulfill their duties uprightly and to secure public confidence in public institutions by forbidding improper solicitations to public officials and relevant persons and by prohibiting them from accepting financial or other advantages.” 1

Who it Impacts

The scope (who it impacts) of the “Act” is very specific: any individual performing public duties or employed by public or governmental institutions.  It is more likely than not, investigators and their staff contracted by the pharmaceutical/biotech industry to perform investigational clinical studies are /could be considered to be civil servants or public officials if they are employed by a public or government-owned institution.

To comply with the “Act” and the Korean Government Official Travel Policy (in Korean language only), the meal restrictions of 30,000KRW (~27 USD) per meal or 90,000KRW(~80 USD) per day are clear.   The hotel accommodation cap and class of flights as it relates to the position of the healthcare professional within their institution have to be addressed thoughtfully by the pharmaceutical companies’ country-level affiliates to be applied/communicated.

Best Practices

There are several ways to involve South Korean healthcare professionals in medical events such as investigator meetings. It does require proactive planning and communications:

  • Always seek country-specific legal advice from your local pharmaceutical/CRO affiliates.
  • Complete a table of invitees as they relate to their position within an institution to obtain specific caps related to accommodations/flight class before selecting your venue.
  • Selection of a venue:
    • Outside country (South Korea) -Hotels/Conference Centers that can accommodate the restrictive caps for accommodations/food and beverage
    • In country (South Korea)- Hotels/Conference Centers that are aware of the Act and can accommodate the restrictive hospitality
  • Hybrid Events – consider hosting a face-to-face event in another country (same time zone).  The South Korean sites can be assembled in one local venue or at their institutions and participate in the event virtually.
  • Video/audio capture of the face-to-face event to be professional repurposed in English or translated to Korean via Miller Tanner’s On-Demand Trainer/Learning Management System to provide a secure online training for the healthcare professionals to watch, asks questions to the presenters via the system and even answer assessments questions to determine comprehension of the materials presented.

Sources:  The Improper Solicitation and Graft Act No. 13278, Mar. 27, 2015

How to Comply with HCP Meal Caps

Pharma Event Planners Complying with Meal Caps

How To Comply With Pharma Meal Caps

average pharma meal cap survey results

Providing food and beverage to a physician or nurse attendee during a pharmaceutical-sponsored training event is simple – no big deal, right?

Fact:  It is becoming more of a challenge for pharmaceutical companies and their event planners to provide appropriate yet nominal, healthy food and beverages to physicians and nurses attending these critical clinical research training meetings.

The Pharmaceutical Manufacturers Associations in most countries have written hospitality guidelines, along with certain country laws, in an effort to be transparent to the public to ensure their interaction (providing food and beverage) during training meetings is not considered extravagant or as a way to coerce a healthcare provider to participate in the training.  Implementing these meal cap guidelines can present a challenge regardless of the venue (city) selected by the sponsor.

Meal Cap

Event planners are one of the most creative group of people I have had the pleasure of working with over 20 years in the research industry.  They work so diligently with the hotel and chefs to help select local foods in season and to provide meals suitable for all attendees’ preferences and dietary restrictions while also trying to provide meals that energize the working minds during these intense and often extensive training sessions.

This issue facing all of us is that food costs, staff services, taxes, gratuity are not decreasing in price.  We are all hoping that meal caps established by the Manufacturers Associations and some countries’ governments can consider revisions to be more in line with current costs.

In the meantime, you can count on Miller Tanner Associates to continue working to meet those compliance guidelines!

How to Optimize Your Risk-Based Monitoring Plan

How to optimize your risk based monitoring plan

Over the past few years, the pharma and CRO industries have been focused on creating better quality monitoring, using risk-based monitoring plans, to change and improve the ways that site monitors work. Technology and a risk-based plan outline what to watch for in the data, and define when a monitor should go on site as well as what amount of source data verification is required. One of the variables that is assessed in these risk-based monitoring plans includes directives for staff turnover and staff training needs. Continue reading “How to Optimize Your Risk-Based Monitoring Plan”

Easy Transparency Reporting for Hospitality

Transparency Reporting For Hospitality Made Easy

We know how important transparency reporting is to our clients. As pharma-related companies, you want to provide meaningful training and timely product information to your health professional attendees to ensure that they understand how to best care for their patients. We also know that your priority is to conduct investigational studies in a manner as required by International Conference on Harmonisation and Good Clinical Practices guidelines. Miller Tanner can help support you with our thorough compliance and transparency reporting from beginning to end for each of your medical meetings.

How We Make Transparency Reporting Easy

As a result of the reporting requirements enacted with the “Sunshine Act” under the Affordable Care Act, Miller Tanner made significant investments by adding resources and developing processes to provide the type of transparency reporting required at the conclusion of all clients’ events.  Resources were added to both our Finance and Operations Departments to support the increasing number of reports provided, as well as, the increasing variation of the report templates and directives across different companies.

Our Miller Tanner Compliance Department provides support to both internal and external teams in regards to compliance with guidelines, procedures, and policies and how it relates to our services and the services provided by our clients and vendors. We comply with the myriad laws and codes governing the financial benefits received by physicians. We adhere to all policies and procedures that have been developed by Miller Tanner, as well as, what our clients and/ or governments’ and countries’ requirements are regarding hospitality provided to attendees.

How Miller Tanner Ensures Compliance Throughout Your Meeting

Compliance is the foundation of the work we do from start to finish.

Our process and communication begin as early as each event proposal stage. First, we work with the team to understand and document the client’s and country’s obligations for complying with the hospitality standards set forth by the majority of countries globally.  This document is our “rule book” for the event for all to follow.  Ongoing onsite management of the hospitality provided is key in order to adhere to the guidelines set out per country and per client.  At the conclusion of each event, Miller Tanner implements a collaborative effort between multiple departments to assure the final billing and transparency reporting are correct and accurate.

Face-to-Face Meetings

At every face-to-face meeting, we provide documentation in the following areas to ensure transparency and compliance standards are met:

  • Individual attendance records to sessions for your audit and inspection purposes.
  • Documentation of each attendee’s preference to partake in certain meal types to support healthcare professional spend reporting requirements.
  • Documentation and alerts for potential deviations from client’s or country’s hospitality guidelines for appropriate escalation.

On-Demand Training/Learning Management System (ODT/LMS)

We take compliance one step further. In addition to face-to-face meetings, where training is provided by our clients and their subject matter experts, we can repurpose your training and your voice to our proprietary web-based training system, On-Demand Training/Learning Management System for those companies needing to train and retrain staff outside of a face-to-face meeting. Within our system, we have implemented features to support compliance requirements:

Our ODT/LMS system is built to support 21 CFR Part 11 requirements: for security, electronic signatures, and records.

  • e-signature requirements – this includes username, the purpose of signature, date and time-stamped.
  • e-records – training certificates produced by the end-user only when the client’s training requirements are achieved. We provide the ability to create certificates which include the user’s name, aggregate reporting of the date, time, and name of presentation completed successfully.

We implement security measures within our ODT/LMS system to maintain standards including but not limited to:

  • We have the capacity to create unique end-user accounts and embed security into the system. 
  • We can track when the system was entered through login, providing the last date and time that the end-user entered the system.
  • We’ve secured the system with a password that is required to be changed every 90 days by the end users.
  • Our system provides “attention messages” for the end user to respond if they are still viewing or would like to log out.  This is a key security measure when an end user could be viewing confidential information in an open clinic or institutional settings.
  • Clients are able to measure end users’ comprehension of content through assessment questions, with scoring percentage applied by client preferences. End users can reset their assessments if they did not achieve a passing score.

Our team ensures that whether you are conducting a face-to-face, virtual or hybrid meeting, or using our On Demand Training/Learning Management System you’re in good hands. You can be confident that our team has extensive knowledge in the areas of compliance, confidentiality, and security when it comes to your medical meetings.

Test Your Compliance Knowledge with These 5 Scenarios:

Want to put your knowledge to the test? Test your compliance knowledge with these 5 scenarios.

Scenario 1. If healthcare professionals from France are invited to an event, what information do you need from your meeting planner regarding hospitality?

Answer: Event details including projected costs, agenda and a list of French attendees with contact details has to be submitted in the local language by your legal representative to CNOM, 30-45 calendars in advance of the event. The approval is tactical.

Scenario 2. If healthcare professionals from Belgium are invited to an event, event details including projected costs, agenda, and detail travel information per attendees have to be submitted how?

Answer: Event details including projected costs, agenda, and detail travel information per attendees have to be submitted online 15 business days to MDEON by the client’s legal entity for that country.  Approval in the form a VISA number is issued and is required to be provided with the attendee’s travel documentation.

Scenario 3. If physicians or nurses from Germany are invited to an event, each attendee that is employed by a government-owned institution/clinic must receive what?

Answer:  Each attendee that is employed by a government-owned institution/clinic is considered a civil servant must receive an employer consent to attend the training from their managing supervisor.

Scenario 4. If physicians or nurses from Slovakia are invited to an event, what is submitted to the government’s database post the event?

Answer: A detail list of attendees and addresses is submitted by the legal entity to the National Medical Information Centre.  This register will be consequently published on the website of the National Centre.

Scenario 5. If healthcare professionals from multiple countries are to attend an event provided by the pharmaceutical/biotech industry, which hospitality codes of conduct apply?

Answer: The most restrictive country’s code of conduct for hospitality should be applied to all.

Need help navigating the hospitality compliance regulations for your next meeting? We’re happy to help! Reach out to us here