---
title: Insights (21)
description: News & Updates from Halloran Consulting Group (21)
---

![hcg-service-hero-1](https://hallorancg.com/hs-fs/hubfs/2024%20Halloran%20Site/Global/hcg-service-hero-1.webp?width=300&name=hcg-service-hero-1.webp)

# Insights From Halloran

Show allAIAll PhasesArticlesAudits & OversightCase StudiesClinical & GxP Technology EnablementClinical DevelopmentClinical Development & OperationsClinical Development PlanningClinical Role-Based EngagementsClinical Trial Leadership & OperationsClinical Vendor Management & OversightCommercializationCRO Selection & QualificationData & TechnologyData QualityData ValidationFDA GuidancesGxP Data IntegrityGxP Quality Assessment & RemediationGxP Quality Management System Developmenthealth authorityHealth Authority Meeting SupportIndication Assessment & PrioritizationIndustry Insights & TrendsInspection ReadinessIntegrated Development PlansInvestigational New Drug ApplicationLeadership & Professional DevelopmentLife Sciences Landscape AnalysisMarketing ApplicationsMedical DevicesMedical WritingOrganizational Design & TransformationOrganizational SolutionsPolicyPreclinicalPress ReleasesProcess Assessment & Operational ExcellenceProgram Leadership & ManagementQuality and ComplianceQuality Management SystemRegulatory Affairs and OperationsRegulatory CMC SupportRegulatory IND ReadinessRegulatory Operationsregulatory strategySpecial Designation Assessment & SupportStrategic AdvisingStrategic Program Leadership & ManagementWebinarsWhite Papers

[

Halloran Consulting GroupDec 2, 2021 2:07:00 PM8 min read

## ICH E6(R3) and Retrospective Analysis: Taking RBQM Back to the Future

The team at Cyntegrity, a leading risk-based quality management (RBQM) innovator, engaged ...

Start Reading 

](https://hallorancg.com/insights/2021/12/02/ich-e6r3-and-retrospective-analysis-are-taking-rbqm-back-to-the-future)[

Tiffany LeemkuilNov 16, 2021 3:38:00 PM5 min read

## COVID-19 Vaccinations: The Next Roll Out and What We May Expect

In March of 2020, ‘pandemic’ – defined by Merriam Webster as – an outbreak of a disease ...

Start Reading 

](https://hallorancg.com/insights/2021/11/16/covid-19-vaccinations-the-next-roll-out-and-what-we-may-expect)[

Halloran Consulting GroupNov 9, 2021 2:21:00 PM4 min read

## Taking Clinical Research & Development Into the 21st Century

Clinical research is evolving in a new direction – a belief echoed by Saama Technologies, ...

Start Reading 

](https://hallorancg.com/insights/2021/11/09/leveraging-ai-how-saama-is-taking-clinical-research-development-into-the-21st-century)[

Halloran Consulting GroupNov 3, 2021 4:03:00 PM6 min read

## Are Placebo-Controlled Studies Still Ethical

The COVID-19 pandemic has been a moving target over the last two years. Changes in the ...

Start Reading 

](https://hallorancg.com/insights/2021/11/03/are-placebo-controlled-studies-still-ethical-for-the-development-of-covid-19-therapeutics)[

Nicole GalloNov 1, 2021 11:46:00 AM1 min read

## The Launch of Bespoke Gene Therapy Consortium (BGTC)

On Wednesday, October 27, 2021, the NIH announced that they will be partnering with the ...

Start Reading 

](https://hallorancg.com/insights/2021/11/01/the-launch-of-the-bespoke-gene-therapy-consortium)[

Emily MoyersOct 14, 2021 3:58:00 PM7 min read

## Essential Elements to Project Management During Operational Disruption

Effective project management can be difficult for any organization, especially for life ...

Start Reading 

](https://hallorancg.com/insights/2021/10/14/essentials-elements-to-project-management-during-operational-disruption-in-life-science)[

Halloran Consulting GroupSep 24, 2021 1:55:00 PM12 min read

## Safety, Efficacy, Politics: FDA and a New Presidential Administration

From the onset of the COVID-19 pandemic, the world has witnessed a dramatic competition ...

Start Reading 

](https://hallorancg.com/insights/2021/09/24/safety-efficacy-and-politics-fda-and-a-new-presidential-administration)[

Halloran Consulting GroupSep 7, 2021 4:11:00 PM5 min read

## Operational Disruption: Assuring Clinical Data Integrity

During a Halloran-hosted Speaker Series on “Operational Disruption: Assuring Clinical ...

Start Reading 

](https://hallorancg.com/insights/2021/09/07/operational-disruption-assuring-clinical-data-integrity)[

Halloran Consulting GroupAug 13, 2021 4:01:00 PM4 min read

## Is the Accelerated Approval Pathway at Risk?

The health care industry is still reeling from the aftershocks of the accelerated ...

Start Reading 

](https://hallorancg.com/insights/2021/08/13/is-the-accelerated-approval-pathway-at-risk)[

Halloran Consulting GroupJul 30, 2021 4:21:00 PM4 min read

## Boeing 737 and Lessons Learned for Medical Device Industry

Recent tragic crashes of two Boeing 737 Max airplanes have sparked ongoing investigations ...

Start Reading 

](https://hallorancg.com/insights/2019/07/30/boeing-737-and-lessons-learned-for-medical-device-industry)

[Load more posts](https://hallorancg.com/insights/page/22)

<https://hallorancg.com/insights/page/21#>

```json
{
  "@context" : "https://schema.org",
  "@type" : "Organization",
  "address" : {
    "@type" : "PostalAddress",
    "addressCountry" : "",
    "addressLocality" : "Cambridge",
    "addressRegion" : "MA",
    "postalCode" : "02142",
    "streetAddress" : "245 Main Street"
  },
  "knowsLanguage" : "en",
  "logo" : {
    "@type" : "ImageObject",
    "url" : "https://9483922.fs1.hubspotusercontent-na1.net/hubfs/9483922/Orange%20Tree%20Blue%20Text.png"
  },
  "name" : "Halloran Consulting Group, a PLG Company",
  "url" : "https://hallorancg.com/insights/page/21"
}
```