Month: September 2024

Thank You!

The GTNF, scheduled Sept. 24–26 in Athens, is made possible by the generous support of these sponsors.
TR Staff Report
Accorto Regulatory Solutions is a boutique regulatory firm committed to providing unparalleled regulatory and compliance solutions for its global clientele across a range of U.S. Food and Drug Administration-regulated sectors. It specializes in helping small-sized to mid-sized domestic and international companies navigate the regulatory landscape to bring their regulated product concepts to market and ensure ongoing compliance following market authorization.
Its team has extensive experience in the tobacco harm reduction industry, with a proven track record of delivering high-quality, data-driven FDA regulatory submissions for its clients’ nicotine-containing products. Its bespoke multi-phase submission approach reduces overall project time and cost while ensuring compliance with the FDA’s most current thinking. It strives to be a trusted partner in navigating and overcoming regulatory challenges, driving success for its clients in a complex market.
Alliance One International (AOI) is a leading independent leaf tobacco supplier. Working with tobacco farmers in 20 countries, AOI is recognized for producing sustainable and traceable leaf tobacco. The company purchases tobacco on five continents and ships to customers in 90-plus countries.
Through direct contracts, AOI is able to provide agronomic expertise and technical guidance to help growers improve the quality and yield of their crops. The company is dedicated to supporting efforts to address human rights concerns in the tobacco supply chain by using on-farm good agricultural practices assessments to evaluate contracted farmers’ compliance with labor practices. Additionally, the company establishes contract terms and conditions with tobacco farmers related to issues such as forced and child labor, and it conducts social compliance due diligence throughout its tobacco-growing regions.
AOI’s Sentri track-and-trace platform provides transparency into the life cycle of agricultural products by monitoring information and obtaining data related to the growth, cultivation, harvest, processing, formulation, testing and release of individual batches of products. By obtaining data on products at each stage of the supply chain, Sentri permits proactive decision-making for both the company and its customers.
AOI believes that everything it does is to transform people’s lives in order to grow a better world. The company’s global ESG strategy was built off its strong sustainability legacy and achievements over the years. Given its diverse global footprint, AOI is well positioned to have a wide-reaching impact on systemic issues. AOI’s sustainability strategy aligns with the United Nations Sustainable Development Goals, and the company is committed to doing its part to help make those goals a reality.
AlphaScale Technologies develops industrial-grade and high-reliability analog/mixed-signal integrated circuits (ICs) and systems for industrial and consumer markets. The company’s product portfolio includes battery and power management ICs, sensors, LED display drivers, analog-to-digital converters, microprocessors and micro-controller ICs. The company’s solutions focus on addressing the performance, reliability, power and cost challenges. The company’s mission is to be an indispensable provider of highly scalable and highly reliable building blocks for the world’s most demanding electronic manufacturers.
AlphaScale was founded by a team of seasoned IC designers from Silicon Valley with a proven track record of developing leading-edge analog and mixed-signal ICs and systems. The company has R&D and operation facilities in the San Francisco Bay Area and China.
Applied Research and Analysis Co. (ARAC) is a social and behavioral sciences research firm that designs, executes and leads scientifically rigorous, customizable Module 6 studies to support manufacturers, regulatory agencies and industry consulting firms.
ARAC is a fully staffed contract research organization with in-house psychologists, behavioral scientists, statisticians and survey methodologists offering tailored research solutions with unparalleled integrity and an exceptional client experience. In-depth knowledge of U.S. consumer behavior, leveraging in-house internal expertise to deliver quicker, streamlined results to client partners.
Based in the U.S., ARAC focuses on achieving global market success by combining regulatory expertise, consumer understanding and cultural competency expertise applied to international markets. Its triangular approach focuses on government regulations, the consumer and its clients’ business objectives. This approach has proven successful across a variety of studies, including label development and comprehension, human factors/usability, clinical behavioral studies, specifically randomized experimental trials, TPPI and postmarket surveillance systems.
The BAT Group is a leading multi-category consumer goods business that provides tobacco and nicotine products to millions of consumers around the world.
BAT’s purpose is to create “A Better Tomorrow” by building a smokeless world. A smokeless world built on smokeless products, where, ultimately, cigarettes have become a thing of the past.
In order to deliver this, BAT is transforming into a smokeless business, with a target for 50 percent of its revenue to come from smokeless products by 2035.
BAT’s portfolio of smokeless tobacco and nicotine products includes vapor products, heated products and modern oral products, which are collectively termed the “new categories,” as well as traditional oral products.
The business continues to be clear that combustible cigarettes pose serious health risks, and the only way to avoid these risks is not to start or to quit. To help build a smokeless world, BAT encourages those who would otherwise continue to smoke to switch completely to scientifically substantiated smokeless alternatives.
BMJ is the world’s No. 1 partner in specialty paper and packaging by responsibly providing high-value products to its customers. With sustainability goals in mind, the company exceeds the industry’s standard through intimate knowledge of customers’ articulated expectations, service excellence, high productivity, high quality and rapid innovation. It is the partner of choice of many leading players in the industry.
Boegli-Gravures designs, develops and manufactures state-of-the-art embossing tools and solutions for an exacting worldwide clientele. The company’s combination of artistic vision and engineering excellence has brought it recognition as a world leader in high-precision embossing and as an original equipment manufacturer supplier. The secret of Boegli-Gravures’ success lies in the company’s vision and passion for innovation.
FEELM, an atomization technology brand affiliated to Smoore, is a high-quality closed system and disposable solution provider that leverages the world’s leading ceramic coil heating technology, faithful flavor reproduction technology and innovative electronic technology. With the vision of “Atomization makes life better,” FEELM continues to extend the boundaries of atomization technology with
FEELM has won numerous prestigious industry awards, including a Golden Leaf Award and Vapouround’s Award for innovation, and global design awards, such as the IF Design Award, the Red Dot Award and the German National Design Award. Products equipped with FEELM’s ceramic coil, with a total production volume of 3.5 billion, have been sold in more than 50 countries and are widely praised.
Greentank is a business-to-business technology company that specializes in the design, development and manufacturing of precision-made inhalation devices and atomization technology. Greentank’s latest innovation in atomization is called Quantum Vape, which replaces cotton wick and ceramic heating elements with a state-of-the-art patented Heating Chip (see “Heated Breakthrough,” Tobacco Reporter, June 2024).
Greentank believes the Heating Chip outperforms all other leading atomization products. For example, it performs better on key safety metrics, such as harmful and potentially harmful constituents and heavy metal testing, than other leading technologies in the market. It also produces superior flavor and a consistent consumer experience.
The company has won multiple industry accolades and honors, including a Red Dot Design Award and Independent’s Vape Tank and Single-Use Vaporizer of the Year distinctions.
Founded in 2009, Hangsen International Group is a world-leading supplier of e-liquid solutions integrating R&D, manufacturing, sales and services. Since its establishment, Hangsen has been committed to producing safe and reliable e-liquid products and solutions for the global e-cigarette industry.
Headquartered in Shenzhen, China, Hangsen has offices and R&D centers in many places around the world. Its business covers more than 80 countries and regions, and it has established a complete global supply chain system. Hangsen also has a production base in Poland.
The domestic manufacturing center has 6,000 square meters of 100,000-class dust-free workshops, covering a total area of more than 30,000 square meters. It has passed ISO9001, GMP, HACCP, CNAS and other international authoritative certifications. Hangsen can provide a complete supply chain solution for the e-cigarette industry, and the service scope includes design, research and development, production, compliance testing, after-sales and other links.
As the pioneer of e-cigarette technology, Hangsen has obtained more than 300 industrial technology patents and intellectual property rights.
The Haypp Group is focused on the global transition from smoking to reduced-risk nicotine product alternatives, especially nicotine pouches. Originating in Scandinavia, the group has extensive experience in the pioneering smoke-free markets of Sweden and Norway and is a leader in the e-commerce sector. The Haypp Group is present in seven countries, where it served more than 1 million active consumers with eleven e-commerce brands in the 12 months to June 2024.
Imperial Brands is a global consumer organization operating in more than 100 markets and the world’s fourth-largest international tobacco and nicotine company. Its brands include JPS, Gauloises and Davidoff cigarettes, Blu vapes, the Pulze and iD heated-tobacco systems, and Zone oral nicotine pouches. In the U.S., the company’s ITG Brands subsidiary offers a broad portfolio of cigarette and mass-market cigar brands, including Winston and Backwoods.
Driven by insights and data, Imperial Brands seeks to meet the expectations of adult smokers by putting the consumer at the center of everything it does. The business is also refining its ways of working and its culture to foster a strong challenger mindset among its 25,000 employees worldwide.
Japan Tobacco International (JTI) was formed in 1999 when its parent company, JT Group, acquired the non-U.S. operations of RJR Nabisco. Since then, the company has achieved over two decades of growth. As a leading international tobacco company, it sells its products in more than 130 markets and is the global owner of both Winston and Camel, the second-largest and third-largest cigarette brands in the world, respectively. JTI’s other global brands include Mevius and LD. JTI is also a major player in the reduced-risk products category with its heated-tobacco brand Ploom, its e-cigarette brand Logic and its Nordic Spirit nicotine pouches.
Creating fulfilling moments. Creating a better future. This is JTI’s purpose; what inspires every single one of its employees. JTI is committed to serving the needs and demands of its adult consumers, supporting the communities it operates in and making its business not only the fastest growing of its kind but also the most innovative and sustainably run.
Today, JTI has more than 46,000 employees driving its success all over the world. Headquartered in Geneva, Switzerland, it was awarded Global Top Employer for the 10th consecutive year in 2024.
Juul Labs is on a mission to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use and combat underage usage of its products. The company believes that vapor products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco.
Körber is an international technology group with more than 12,000 employees at over 100 locations worldwide. In its Digital, Pharma, Supply Chain and Technologies business areas, the Körber Group offers products, solutions and services that inspire. The Körber business area Technologies develops customized solutions in the areas of machinery, equipment, software, measuring instruments, flavors and services with a focus on the tobacco, food and beverage industries. Beyond this, its range of offerings includes innovative concepts for battery cell production. With its 25 global production, sales and service locations, the company sees itself as a strategic partner to its customers. Always keeping their goals in mind, the company delivers and integrates outperforming technologies with passion, precision and performance to help them reach their full potential.
As part of Certified Group, Labstat is committed to delivering high-quality technical solutions that its customers can feel confident in—on time, every time—“so the world can trust in what it consumes.” As one of the world’s largest independent testing laboratories, Labstat specializes in analytical chemistry, in vitro toxicology, microbiology, method development and customized technical services for global clients in the tobacco, nicotine, cannabis, hemp and natural health product categories.
Reynolds American Inc. (RAI) is a wholly owned subsidiary of the BAT Group and the U.S. parent company of R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co., American Snuff Co., R.J. Reynolds Vapor Co., and Modoral Brands. RAI’s vision is to build “A Better Tomorrow” by reducing the health impact of its business through offering a greater choice of innovative products for adult tobacco consumers.
Founded in 2009, Smoore is a global leader in atomization technology solutions, covering reduced-risk products, medicinal, special-purpose vaping devices and beauty atomization technologies.
Continually investing in R&D and leading in manufacturing capacity, Smoore has nine technology research centers worldwide, and its products are available in more than 100 countries and regions.
With a focus on interdisciplinary atomization research and a diverse product portfolio, Smoore is committed to becoming an advanced platform with the aspiration to make life better.
SWM International is a leading global provider of highly engineered fine papers, with a deep expertise in natural fiber-based solutions. The company has historically provided solutions for conventional cigarettes, rolling papers, tubes, machine-made cigars and cigarillos as a partner of the tobacco industry.
Recently, significant investments have been made in next-generation product categories, such as heated-tobacco products, modern oral and recreational cannabis applications. SWM’s unmatched product and capability portfolio and expert service offerings cater to both the combustible and the smokeless markets.
Driven by innovation, SWM focuses on accelerating the transition toward safer and more sustainable solutions across the industry.
Global brands across industries rely on Systech to help them achieve compliance, combat counterfeiting and detect diversion. Systech partners with electronic nicotine-delivery system companies to prevent youth usage with age-gating and root out illicit products.
Systech provides digital traceability and authentication solutions that deliver essential product data, ensure digital connectivity and enable real-time insights across supply chains. With decades of experience in highly regulated industries such as pharmaceuticals and medical devices, Systech delivers solutions that customers trust to bring billions of critical products to the market safely.
Tamarind Intelligence provides essential guidance and data-based strategic insights to professionals in fast-moving sectors focusing on consumer-facing products. The areas its selects to cover are in opaque regulatory environments and difficult policy areas where businesses need to be on top of industry developments to make informed decisions and optimize their strategy.
Operating since 2014, the company provides the most accurate information available through consolidated, consistent methodology and research. Its team of lawyers, economists and journalists has long-term expertise in these markets, enabling the company to provide relevant and actionable guidance to its clients. Since the company is independent from the sectors it covers, it gives its clients access to objective analysis often not available to other industry participants.
Founded in 1975 in Maryland, Tobacco Technology Inc. (TTI) develops customized flavors and casings for smoking products, including cigarettes, water pipe, snuff, snus, chew, kretek, RYO, pipe tobaccos, e-liquids and white nicotine pouches. TTI also offers consulting services to facilitate flavor, process and product development.
E-LiquiTech (ELT), a TTI subsidiary established in 2016, is dedicated to the development and manufacturing of the highest quality e-liquids in addition to offering both bottle and cartomizer filling services. ELT is also the exclusive global distributor to the tobacco industry for Zanoprima, a research-driven, innovation-led life sciences company, offering SyNic high-purity synthetic (S)-nicotine in pure, bitartrate and polacrilex resin form.
TTI Flavors is its manufacturing facility in Assisi, Italy, making TTI products for the EU and Middle Eastern markets.
In 2022, TTI established Emerald Green Technology (EGT). With the rise of the emergent cannabinoid marketplace, EGT was born as a natural extension of TTI’s family of flavor companies. It offers a vast array of cannabinoid flavor profiles for CBD and hemp products. Infinite cannabinoid possibilities—if you can imagine it, EGT can create it!
Universal Corp. is a global agricultural company with over 100 years of experience supplying premium ingredients and innovative solutions to meet its customers’ evolving needs and precise specifications. Through its diverse network of farmers and partners across 30 countries on five continents and its commitment to sustainability, the company is a trusted provider of high-quality, traceable products. It leverages its extensive supply chain expertise and state-of-the-art agri-product capabilities to provide a range of products and services designed to drive efficiency and deliver value to its customers.
Founded in 2016 and headquartered in Shenzhen, China, Zinwi Biotech Co. is a high-tech company that specializes in providing integrated solutions, including research, production, sales and services, to global e-cigarette manufacturers and brands. Today, Zinwi Biotech is one of the world’s leading e-liquid companies owing to its strong research and development, strict quality control procedures, stable product quality and large client network.
With innovation at its core, Zinwi Biotech focuses heavily on product research and development. In addition, it focuses on reduced harm technology innovation and application. In 2020, Zinwi Biotech established its Atomization Technology Research Center focused on breaking technological barriers and obtaining patents.
In terms of production and quality control, Zinwi Biotech has gained a number of certificates, including the National CNAS Laboratory Certification, ISO9001, ISO14001 and ISO45001, along with the American GMP Certification. Its products are sold through the network of clients to many countries and regions in Europe, America and the Middle East and have been unanimously recognized by more than 300 brands.

September 1, 2024
Global Ambitions

Photo: Taco Tuinstra

Having firmly established itself as a regional player, Tabaterra of Azerbaijan is preparing to take its operations to the next level.

By Taco Tuinstra

Azerbaijan has been on a tear recently. Whereas in the past, the country was known primarily for fossil fuels, its economy is rapidly diversifying, with investors taking advantage of Azerbaijan’s strategic location along the ancient Silk Road and at the intersection of modern commerce between Europe and Asia. In addition to hosting major international events, including the Formula One Grand Prix this month and the Conference of the Parties to the United Nations Framework Convention on Climate Change in November, Azerbaijan has also been enjoying a boom in manufacturing and services, with companies investing in areas as varied as information technology, logistics and agriculture.
Among the new factories that have sprung up in recent years is also a cigarette-making facility. Eager to localize imports and create the conditions for exports, Tabaterra in 2018 built a factory in Sumgayit, just north of Azerbaijan’s capital, Baku, with eight production lines and an annual capacity of 18 billion cigarettes.
Confident in their partner’s abilities, BAT and Japan Tobacco International immediately assigned their entire Azerbaijani portfolios to Tabaterra. In the fourth year of contract manufacturing, BAT and JTI also awarded Tabaterra their volumes for neighboring Georgia. The multinationals have not regretted their decisions judging by the number of customer accolades displayed at the Sumgayit facility. When JTI evaluated its worldwide contract manufacturers in 2023, for example, Tabaterra finished first.

Tabaterra aims to achieve unprecendented levels of efficiency in its operations.

Building Brands

Buoyed by the success of its contract manufacturing operations, Tabaterra started developing its own brands. The first private label cigarettes, including Argo, Kingston and Senate, rolled off the Sumgayit production lines in 2019. More recently, Tabaterra debuted the Lincoln and X7 brands for export. Additional launches were scheduled for this fall.
Of course, introducing new brands is notoriously challenging in the cigarette business. Not only must newcomers compete against long-established international trademarks, but they must also do so in increasingly “dark” markets. Like many other countries, Azerbaijan restricts tobacco promotions to the point of sale, severely limiting opportunities for developing brand awareness.
“Brand building is not easy,” acknowledges Tabaterra Director Elman Javanshir. “It takes time and money.” In addition to competing with the name recognition of foreign cigarettes, he explains, local brands must overcome the prejudices of consumers, who in Azerbaijan and other markets tend to perceive global brands as “better,” even if the quality is comparable to that of their locally produced counterparts. “So you have to make sure that your brand is much better than its international equivalent,” says Javanshir. “That also means you must spend more than your competitors—even though you are smaller than them.”
One way to compensate for limited resources is by being creative. For example, Tabaterra developed a smart phone app for its retail partners with information about the company’s portfolio. In addition to detailing product features such as low-odor technology, sweetened filters or cherry flavors, the app allows sellers to earn points that can be exchanged for products, mobile phone credits or cash. The goal, according to Business Development Manager Elchin Murtuzov, is to spread awareness of Tabaterra’s products among vendors. “So when the buyers come, retailers will know these brands and can educate the customers about Tabaterra’s value proposition,” he says.

Following the success of its contract manufacturing business, Tabaterra started producing its own brands.

Relocation

While Tabaterra’s Sumgayit factory is barely six years old, the company has already outgrown the facility. To accommodate its growing volumes and elevate production quality and efficiency to the next level, the company has built a new plant in Aghdam, nearly 400 km west of Sumgayit. The relocation process will start in October, and the company plans to move two production lines every month. In addition, it will install two new lines at the Aghdam factory, bringing the total to 10. The process is scheduled to be completed by the end of February.
According to Javanshir, Tabaterra is going out of its way to make the relocation attractive for its workforce. In addition to increasing salaries by between 30 percent and 50 percent, the company has purchased six buildings with 210 apartments in Aghdam. The residences will be fully furnished and offered free of charge, including utilities and residential fees. “All inventories are supplied by the company,” he says. “Employees just need to bring their clothes and personal possessions.” In addition, Tabaterra will change the work schedule from three eight-hour shifts to two 12-hour shifts, and provide regular transportation to Baku. This means that staff will be off one week every three weeks—time that they can spend in Aghdam, Baku or elsewhere. “The choice is to the employee,” says Javanshir.
Many employees have already indicated their interest in relocating, and Javanshir is confident that a significant share of the workforce will follow their employer to Aghdam. Recently, Best Places to Work, an international ranking organization, recognized Tabaterra as one of the top employers in Azerbaijan for 2024–2025, with 90 percent of employees indicating they were happy with their working conditions.

When you have efficiency, you make the machine work; when you do not have efficiency, the machine makes you work.

Elman Javanshir, director, Tabaterra

Working Smarter

Of course, building a factory from scratch presents not only challenges but also opportunities. Starting from a blank slate permitted Tabeterra to design the factory exactly as it wanted without the constraints of its existing facility. According to Javanshir, the new factory will not only be 30 percent bigger than its Sumgayit plant but also significantly “smarter,” with state-of-the art technology and a high degree of digitalization. “We will have a visual representation of the plant at our Baku head office,” he says. “Management will be able to see in real time which line is working, what brand is being produced and what are the efficiency and waste rates.” In addition, the smart factory will enable Tabaterra to keep track of individual employees’ performances, enabling it to improve both its employee recognition system and efficiency.
Down the road, Tabaterra also wants to integrate artificial intelligence into its operations, allowing it to further boost efficiency and carry out preventative maintenance, for example. Such applications already exist at some multinationals, but Javanshir insists Tabaterra, as a regional player, must create a good basis first. “We will build everything in a rational way,” he says. “The first task is to get all the data visualized and online.”
If done correctly, this should allow Tabaterra to achieve unprecedented levels of efficiency in its operations, which in today’s competitive environment is essential, according to Javanshir. “When you have efficiency, you make the machine work; when you do not have efficiency, the machine makes you work,” he observes.

A growing share of Tabaterra’s output is exported.

Tabaterra’s commitment to quality and efficiency have served it well. Not only has it won the trust of leading cigarette manufacturers, but it also has managed to establish a respectable private-label business in a relatively short time. The company’s brands currently account for 11 percent of Azerbaijan’s 14.5 billion-stick market, and they are making inroads in Georgia and Iraq.
But Tabaterra is not content to rest on its laurels. “Eleven percent is not our target,” says Javanshir. “Our aim is to get 20 percent of the market in Azerbaijan.” Meanwhile, the company is already looking further afield, analyzing opportunities in additional overseas markets. To further raise awareness internationally, the company regularly participates in international tobacco expositions. This month, for example, it is scheduled to exhibit at Intertabac in Dortmund, and in November, it will participate in the Word Tobacco Middle East show in Dubai. The company has also been investing in leaf production.
Asked to explain the company’s success, Javanshir cites good relationships with industry leaders and an eagerness to learn. For example, in preparation for its Sumgayit factory, Tabaterra sent many of its staff members to its partner companies’ facilities. In return, experts from the multinationals came to Azerbaijan to provide hands-on training. The company has also benefited from the recent trend toward localization, with businesses rediscovering the value of physical proximity to end markets.
A healthy combination of ambition and realism has helped as well. Even though cigarette volumes in Azerbaijan have been stable, Tabaterra is well aware of the dimming outlook for traditional tobacco products worldwide. That’s why the company has also started exploring new platforms, such as heat-not-burn devices. “If you want to be sustainable, you must keep up with technology,” says Javanshir, noting that many companies who failed to do so don’t exist anymore. “We will not have the same fate,” he says.

Taco Tuinstra is Tobacco Reporter’s editorial director. Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors. On his watch, Tobacco Reporter has won several awards for editorial excellence. Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.

September 1, 2024
Ensuring Excellence
The critical role of site visits and quality controls in behavioral science research

By Elizabeth DeMartini

In the ever-evolving field of behavioral science research, ensuring the integrity and reliability of data is a critical aspect of quality research. This article details the importance of study site visits and quality controls in maintaining high research standards and ethical conduct for direct interactions between study site staff and participants when conducting behavioral studies, such as in-person consumer perception and intentions, label comprehension and human factors, actual use and switching, product use patterns, and abuse liability.
Study site staff are directly engaging with participants during recruitment and screening for eligibility, explaining and gathering signatures for the informed consent forms, study product administration, data collection and general communication with participants. There are times prior to or during study conduct where important study execution information, which may seem clear to researchers intimate to a project, may be missed or unclear to study site staff. This could lead to issues with data quality and compliance.
This potential knowledge gap can be alleviated by having a regular on-site and virtual presence and directly collaborating with the study site staff throughout the study with increased oversight during key study milestones. With this, stakeholders can ensure successful project implementation while maintaining the integrity of each individual research project.

The Role of Site Visits in Research Integrity

Study site visits are a fundamental aspect of research oversight, serving multiple functions that collectively uphold the integrity of research studies. These visits facilitate direct interaction and collaboration between the research team and study site staff, allowing for real-time monitoring and support. Here are key reasons why site visits are indispensable:
Training and Support—Study site staff play a vital role in the successful execution of studies. The study site’s proper understanding of the study outcomes and methods enhances the quality of the data collection processes, communication between all parties, compliance requirements and overall health of the study. The study site staff will be intimately involved in the project from start to finish, and it is of utmost importance that they are well versed in study protocol, data collection methods and ethical considerations. Being on-site allows researchers to educate the study site staff through each step of the study. Many projects involve study products that participants are trained to use. For study site leaders to train these participants, researchers must feel confident that they have trained each research site well. Being on-site at these trainings allows for a hands-on approach, enhancing the competency of the study site staff and fostering a collaborative environment where questions and concerns can be addressed promptly.
Ensuring Protocol Compliance—Adherence to institutional review board-approved study protocols is crucial for the validity and reliability of research findings. Site visits oversee and verify that study procedures are being followed as outlined. This helps identify deviations or noncompliance issues early, allowing for timely corrective actions. Researchers’ presence on-site throughout project milestones ensures that the study site staff feels confident in implementing these critical study procedures. Remote monitoring of adverse events and clinical assessments of side effect severity related to research study product use is a critical responsibility. It is good practice to have a medical monitoring team on call for this service. Consistent with the informed consent form, participants should be educated on what adverse events may be and when to call, and encouraged to always err on the side of caution. By providing this surveillance, researchers can detect any potential safety concerns and address the next steps promptly.
Building Relationships—Face-to-face interactions during site visits strengthen the relationship between the central research team and site personnel. This is essential for effective communication and coordination throughout the study. A strong relationship facilitates smoother operations and encourages site staff to proactively report issues and seek guidance when needed.
Many contract research organizations view study sites mainly as a transactional engagement, often with limited oversight. However, this approach is fundamentally short-sighted. The strength and integrity of a study’s data hinge on the meticulous execution of the research protocol, which can only be achieved through genuine, trusted partnerships with study sites. By fostering collaborative relationships and investing in mutual trust, organizations should ensure that the research is conducted with the highest level of precision and dedication. This partnership-based approach not only enhances the quality of data but also drives successful outcomes that meet both regulatory standards and the nuanced needs of clients.
Assessing Facility Capabilities—Evaluating the layout of the research sites infrastructure and assessing their capabilities is a necessary component of site visits. Research protocols include standards for product storage, document storage, product disposal, and in some cases survey administration. By being on-site, research organizations can assess the facility’s capabilities and preparedness to ensure they are complying with all regulations. Site visits can also help the research team work with the study site staff to create a comfortable flow and environment for participants engaging in the research. A proper study environment is necessary to produce high-quality data.
Quality Controls in Research: A Multidimensional Approach

Quality controls are the backbone of any research endeavor, ensuring that the data collection is accurate, reliable, robust and valid. In the case of social and behavioral science research, quality controls encompass a range of activities designed to maintain high standards and ethical conduct. Key aspects of quality control include:
Data Integrity—Maintaining the integrity of data collected during a research study is essential for producing credible results. Professional research organizations employ an in-house survey methodologist who is responsible for a multitude of quality control measures surrounding data integrity, including validation checks built into the survey and real-time data audits with daily reports on any data that would reflect any discrepancies. The survey methodologist works closely with the team and sites throughout each step of the entirety of the research process and especially during the first days of study implementation, confirming correct participant eligibility, assignment and data quality.
Ethical Conduct—Upholding ethical standards in research is a fundamental principle. Quality assurance processes are designed to ensure that all study activities are conducted with a focus on human subject protections. This includes obtaining informed consent, ensuring confidentiality and conducting research in a way that respects participants’ rights and dignity, which the study site staff are trained prior to and on the same day as first-participant-in.
Challenges and Solutions in Implementing Site Visits and Quality Controls

Despite the clear benefits, implementing site visits and quality controls can present challenges. Addressing these challenges requires a proactive and adaptive approach.
Resource Constraints—Conducting site visits and maintaining rigorous quality controls are essential components of any successful study, but they can be resource-intensive endeavors. Adequate funding, staffing and logistical support are crucial to carrying out these activities effectively. Medical monitoring teams play a pivotal role in this process, ensuring that every site adheres to the highest standards of patient care and protocol compliance.
To address these challenges, research organizations should focus on optimizing resource allocation, ensuring that their teams are well supported and strategically deployed geographically. Leveraging technology for remote monitoring allows organizations to maintain oversight without the need for constant physical presence, which not only conserves resources but also increases agility in responding to emerging issues.
Geographical Barriers—Research studies often involve multiple sites across diverse geographic regions, making the logistics of conducting frequent site visits a significant challenge. To address this, it is advisable to employ a risk-based approach to site selection, prioritizing visits based on project timeline milestones and the specific needs of each study. This strategic approach ensures that resources are directed toward the most critical sites where oversight can have the greatest impact.
Professional contract research organizations place a strong emphasis on rigorous project management across multiple geographic regions. This involves close collaboration with the institutional review board, whose oversight and guidance should be integral to the organization’s approach. Oversight plans should involve initial site evaluations, frequent and transparent communication between sites and the research team, and ongoing supervision to uphold protocol integrity and data quality. By integrating these elements into the project management plan, organizations can maintain consistency, compliance and excellence across all study sites, no matter where they are located.
Standardization Across Sites—Ensuring consistency in study conduct across multiple sites is crucial for data comparability. Developing comprehensive procedures and conducting training sessions can help standardize procedures. Regular communication and site support also play a vital role in maintaining consistency. For example, with the research team’s presence on-site during first-participant-in, the research team can provide oversight and intervene to correct any errors in study administration, and the study site staff are able to discuss any questions they may have in real time. This allows for high-quality compliance to be achieved. It also allows the research team to address reoccurring issues and modify their site training materials to be more comprehensive for all study sites.
Evolving Regulatory Requirements—Regulatory landscapes are dynamic, with frequent updates and changes. Staying abreast of regulatory requirements and ensuring compliance can be challenging. Engaging with regulatory bodies, participating in industry forums, and continuous education for study site staff are effective strategies to navigate regulatory complexities.
Conclusion

The importance of site visits and quality controls in behavioral research cannot be overstated. These practices are essential for ensuring the integrity, reliability and ethical conduct of research studies. By fostering close collaboration between the central research team and study sites, providing thorough training, support, availability, strong relationships, as well as implementing robust monitoring and quality assurance processes, contract research organizations can ensure that their research endeavors produce credible, high-quality data that advance innovation and regulatory compliance in the nicotine industry. Ultimately, these efforts contribute to the overarching goal of protecting human subjects, quality data collection and enhancing public health outcomes.

Elizabeth DeMartini is a medical monitor and researcher at Applied Research and Analysis Co. (ARAC). She brings a wealth of experience from diverse roles in the healthcare and wellness sectors spanning the last two decades.

An alumna of James Madison University, DeMartini holds a Bachelor of Science degree in nursing. Demartini is a licensed registered nurse through the Virginia Board of Nursing and is authorized to practice in 38 additional U.S. states. Together with Brianne Becht, DeMartini initiated ARAC’s medical monitoring team, enhancing standardization with on-site facility trainings, clinical assessments and compliance oversight.

ARAC is a social and behavioral sciences research firm known for designing, executing and presenting creative, customizable Module 5 and 6 studies to support manufacturers, regulatory agencies and industry consultants. The fully staffed contract research organization employs in-house psychologists, behavioral scientists, statisticians and survey methodologists.

ARAC’s data-driven approach ensures rigorous, evidence-based insights to support innovation and regulatory compliance in the nicotine industry.

The ARAC team services clients worldwide in product development and consumer research supporting innovation and “next-generation” products, with focused expertise on the regulatory sciences for U.S. applications, including ITPs, premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence applications.
September 1, 2024