# PAASPort: A web-based tool for nonclinical research quality assessment and risk of bias management to advance development of innovative medications

> **NIH NIH R44** · PAASP US, LLC · 2020 · $223,300

## Abstract

PROJECT SUMMARY / ABSTRACT
 Robust nonclinical data is an absolute requirement for building an effective translational strategy and
developing clinically safe and effective medications. Most current efforts to facilitate generation of robust
nonclinical research data focus on producing guidelines and checklists pertaining to study design and
data analysis, but: a) do so only from a reporting perspective; b) do not consider processes other than
study design and data analysis, such as compliance of data records with FAIR principles; and c) are at
risk of triggering normative responses, whereby scientists simply satisfy the guidelines at a time when it
is too late to take corrective actions. In this regard, and in line with RFA-DA-19-031, the current
application proposes to develop, validate and introduce into common practice a novel web-based tool
called PAASPort for early identification of potential risks of bias and support of decision making related to
nonclinical research practice. PAASPort consists of a web application with proprietary analytics
supporting project-specific and research unit-specific certification.
 In Phase 1, we will (Aim 1) convert the existing PAASPort prototype, which is currently a questionnaire in
Microsoft Word format where data are manually organized and analyzed by a PAASP employee, into a web-
based, interactive digital tool that can be accessed online at the research unit’s convenience and data will be
automatically processed and prepared to provide feedback to the PAASPort customer (e.g., foundations,
private investors, VCs, pharma); (Aim 2) enhance the commercial value of PAASPort by asking different
groups of private investors how they value the different aspects of bias in research practice related to 1) study
design and conduct, 2) data integrity, 3) quality culture, and 4) organizational and individual factors. In Phase
2, we will: (Aim 1) implement analytical mechanisms to support semi-automated processing of information
collected from the online assessment; (Aim 2) minimize normative responses to the online assessment by
introducing onsite audit-based feedback control, and (Aim 3) demonstrate economic benefits of improved
nonclinical research practice quality assessments for private investors. The tool will be developed and
validated with neuroscience and, more specifically, substance use disorder drug discovery in focus, but it can
be extrapolated to other disease indications and therapeutic areas. The most immediate impact of the
proposed tool is to avoid normative responses to emerging standards in research quality. However, given that
PAASPort-supported data are expected to be more robust, the ultimate goal is to facilitate decision making,
industry-academia partnerships, and the advancement of fundamental discoveries into commercial
development.

## Key facts

- **NIH application ID:** 9886100
- **Project number:** 1R44DA050162-01
- **Recipient organization:** PAASP US, LLC
- **Principal Investigator:** ANDRE DER-AVAKIAN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $223,300
- **Award type:** 1
- **Project period:** 2020-02-01 → 2020-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9886100

## Citation

> US National Institutes of Health, RePORTER application 9886100, PAASPort: A web-based tool for nonclinical research quality assessment and risk of bias management to advance development of innovative medications (1R44DA050162-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9886100. Licensed CC0.

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