top of page
Bar Chart

TRUSTED PARTNERS

Proven reliable methods to optimize clientele cost and increase regulatory engagement in:

  • Perception and behavior research

  • Product development

  • Application success

About ARAC

U.S. based behavioral science research firm

ARAC is a leading U.S. based behavioral science research firm that designs, executes, and presents scientifically-sound, yet customizable studies to support manufacturers, regulatory agencies, and industry consultants. Their expertise includes consumer-focused research services in product development and innovation and regulatory science supporting marketing authorization applications, with SUCCESS in U.S. product authorizations and applications.

 

ARAC specializes in MODULE 5 & 6 studies including: label/claim development and comprehension, human factors/usability testing, and clinical/behavioral studies, such as randomized experimental longitudinal, actual use, TPPI, and post-market surveillance systems.

 

“Most Outstanding Service to Industry” 2024 Golden Leaf award-winning fully staffed IN-HOUSE psychologists, behavioral scientists, statisticians, survey methodologist, and medical monitoring offering tailored research solutions with unparalleled integrity and an exceptional client experience.

Neurotechnology

Innovation &

Product Development

​Development Stages:

• Ideation & Concept Testing

• Validation

• Prototyping

• Marketing

​

Core Methods:

• Feasibility Study

• Concept Testing

• Sensory Product Research

• Pilot Testing

Qualitative

Research

• FOCUS GROUPS

​

• MODERATOR SKILLS

​

• ETHNOGRAPHY

​

• DIARY STUDIES

​

​

​

​​​​​​​​​​

Quantitative

Research

• CORRELATIONAL RESEARCH

​​

• EXPERIMENTAL RESEARCH

​

• INFERENTIAL STATISTICS

​

• SURVEY DEVELOPMENT

​​​​​​​​​​

​​​

​

FDA CTP

Applications

• ITP​

​

• PMTA

​

• MRTPA

​

• SE

​​​​​​​​​​

​

​

​

CORE COMPETENCIES

Global network partnerships offer cross-cultural expertise to fulfill consumer cultural competency.

Meeting Room

Pre-Market Tobacco Application (PMTA)

MODULE SIX STUDIES

Module 6 addresses the clinical particulars and risks associated with the use of the proposed tobacco product at a population level. Clinical population health assessments should be formed based on whether human behavior, perceptions, and intentions related to a candidate product are Appropriate for the Protection of Public Health (APPH), with consideration of population modeling.

The thoroughness and scientific rigor of the information provided in this module significantly influence the FDA’s decision on whether to authorize the product for marketing authorization.

To demonstrate that a new candidate product is APPH, the FDA recommends applicants submit reliable and robust data showing the benefit of product authorization onto the market.

Module 6 of a Premarket Tobacco Product Application (PMTA) focuses on considerations in addressing the human health impact of a new tobacco product including:

  • Consumer perceptions & intentions (TPPI)

  • Labeling comprehension and likelihood of misuse (Label Comprehension & Human Factors)

  • Likelihood of initiation and cessation by both users and nonusers of tobacco products (Actual Use & Switching)

    • Longitudinal Cohort Studies (LCS)

    • Longitudinal Randomized Experimental Switching Study (LRESS)

    • Randomized Control Trials (RCT)

  • Product use patterns (Actual Use & Topography, may or may not include BOE)

  • Abuse liability (PK & Subjective Effects)

CONTRACT TIMELINE

1

Sign ARAC’s Non-Disclosure Agreement (NDA)

2

Consultation + review & sign PROPOSAL

3

Sign ARAC’s Statement of Work (SOW) + PROJECT EXECUTION

4

PRE-SUBMISSION MEETING | Consulting, Legal, & FDA

5

Project Completion

Strongly recommended to conduct a PRE-SUBMISSION MEETING, often in partnership with consulting and legal firms + FDA, to help ensure that your regulatory product application strategy and science are well-aligned with FDA expectations, thus increasing the chances of a

successful submission.

SUCCESS STORIES

PMTA AUTHORIZATION

PMTA SWITCHING STUDY - COMPLETE & SUBMITTED TO FDA: E-Liquid Manufacturer

  • Conducted RCT on flavored vs. tobacco-tasting e-liquids

  • Presented findings to FDLI, demonstrating significant reduction in Cigarettes per Day with flavors compared to tobacco-tasting

PMTA SWITCHING STUDY - IN PROGRESS: Disposable Product

  • Switching Study submitted to FDA and IRB in July 2024

  • Fielding in August 2024

MRTPA AUTHORIZATION

PMTA STUDY - COMPLETED:
Disposable & E-Liquid Manufacturer

  • ITP submitted with leading regulatory consulting firm

  • Worked with multiple government agencies to ensure product entrance and compliance.

  • Results to be presented at FDLI & TSRC

PMTA SWITCHING STUDY - COMPLETED: Oral Nicotine Pouch, Lozenge, & Gum

  • Designed & served as client consultant on 6-month actual use study

  • Uniquely designed product distribution process

  • Presented findings at TSRC 2023, with two publications under review in leading scientific publications

PMTA STUDY - COMPLETE & SUBMITTED TO FDA:

  • AGE-GATED ENDs Human Factors & Label Comprehension Study

  • Conducted US-based, in-person mixed-methods HF and LC Study

  • Focused on consumer perceptions, intentions to use, likelihood of misuse, acceptability, and labeling changes.

  • Tested on age-gated vs. non-age-gated device applications

PMTA SWITCHING STUDY - IN PROGRESS: E-Liquid Manufacturer

  • Four-condition Switching Study to assess impact of flavored e-liquids on cessation

  • Submitted to FDA CTP

  • RCT in-field

PMTA TPPI STUDY - COMPLETED: Oral Nicotine Pouch

  • Assessed intentions and perceptions of U.S. users and nonusers

  • Presented findings to PMI, and to be presented at CORESTA

  • Scientific publication to be submitted to peer-reviewed journal August 2024

bottom of page