The ICH E6(R3) draft guideline for Good Clinical Practice (GCP) is expected to be finalized this fall, and it's crucial to prepare now. Join our upcoming webinar, "Preparing for GCP E6(R3) Impacts on Regulatory, Clinical, and Quality," where our experts will cover key changes, considerations, and how to ensure compliance. Don’t miss out—register today to secure your spot! https://hubs.la/Q02NHPWt0 #clinicaltrials #GCP #webinar #regulatoryaffairs #qualityassurance #clinicalresearch
Halloran Consulting Group, Inc.
Business Consulting and Services
Boston, Massachusetts 7,650 followers
Halloran is a life science consulting firm providing strategic regulatory, quality, and clinical insights.
About us
Halloran Consulting Group is a life science consulting firm that provides strategic regulatory, quality, clinical, and organizational support to industry leaders and startup visionaries in the pharmaceutical, biotechnology, and medical device sectors. Our consultants are subject matter experts who deliver a tailored approach to each engagement, successfully propelling our clients to their next inflection point. We connect clients with our trusted industry partners to drive operational excellence and innovation throughout their organizations. Our aim is to support our clients, and the patients they serve.
- Website
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http://www.hallorancg.com
External link for Halloran Consulting Group, Inc.
- Industry
- Business Consulting and Services
- Company size
- 51-200 employees
- Headquarters
- Boston, Massachusetts
- Type
- Privately Held
- Founded
- 1998
- Specialties
- Regulatory Strategy/Submissions, Quality Systems, Clinical Development, Due Diligence, TMF, Organizational Development, Program Management, Gap Analysis, Clinical Finance, Change Management, Vendor Management, Inspection Readiness, Training, Technology Adoption, Clinical Trials, Clinical Research, Virtual Clinical Trials, Decentralized Clinical Trials, Organizational Solutions, Data Management, Technology Implementation, Strategy Management, and Program Leadership
Locations
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Primary
22 Thomson Pl
Boston, Massachusetts 02210, US
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3040 Science Park Rd
San Diego, California 92121, US
Employees at Halloran Consulting Group, Inc.
Updates
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In the evolving landscape of clinical trials, staying ahead of compliance and data integrity is paramount. Our latest blog explores how leveraging Artificial Intelligence (AI) and Central Monitoring (CM) can revolutionize audit preparation and execution. Discover how AI can automate repetitive tasks, enhance data accuracy, and identify outliers missed by human review. Learn how CM data outputs can streamline the selection of investigator sites for audits, focusing on key risk areas efficiently. Read more here: https://hubs.la/Q02Nw1Sw0 #ClinicalTrials #AI #Audit #CentralMonitoring #Pharma #Biotech #Compliance #DataIntegrity
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Are we all thinking the same thing? How is it already Labor Day Weekend? The clock is ticking and year-end is approaching. Get in touch with our team now to help accomplish your team's goals for 2024! Let's get to work: https://hubs.la/Q02N53Yz0
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At Halloran, we provide a strategic roadmap for bringing innovative healthcare solutions to market. Our regulatory team expertly guides your programs through marketing applications (NDAs, BLAs, PMAs, 510(k)s), ensuring success with late-stage development. From advising to authoring and everything in between, we're committed to facilitating your journey to market authorization. Let's get to work! Learn more about our marketing applications services here: https://hubs.la/Q02MYsg50 #LifeSciences #HealthcareInnovation #RegulatoryAffairs #ClinicalDevelopment #MarketingApplications
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Successfully submitting a New Drug Application (NDA) or Biologics License Application (BLA) is a key milestone in the clinical development phase. Discover the pivotal regulatory procedures imperative for biotech and pharmaceutical companies seeking approval for novel drugs and biologics. Watch our recent webinar here: https://hubs.la/Q02Mmp4j0 #NDA #BLA #FDASubmissions #Regulatory #ClinicalDevelopment #Biotech #Pharma #Webinar
Successful Planning for an Original NDA / BLA Submission Webinar
hallorancg.com
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Trends in FDA Form 483s are often related to failure in three key areas. At first glance, these observations may be attributed to sites, however, they illuminate how well the sponsor and/or other vendors performed their oversight responsibilities. Lyn Agostinelli reviews Form 483 common findings, providing insights into the essential role of vendor oversight on the path to inspection readiness. https://hubs.la/Q02M5z220 Preparing for an inspection? Start the conversation today. #InspectionReadiness #VendorOversight #ClinicalTrials #FDAInspection
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Building a collaborative relationship with the #FDA is an essential component of a robust #ProductDevelopment strategy for sponsors intending to bring #NovelDrugs, #Biologics, and/or devices to market. Fortunately, the FDA offers various opportunities for interaction and guidance throughout the development lifecycle. As you begin your FDA interaction journey, consider our key interaction and preparation recommendations: https://hubs.la/Q02LLMVQ0
Conducting an FDA Meeting: A Playbook
hallorancg.com
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Boston Sales Professionals! We're still searching for our next Associate Director of Outside Sales! Join our growing team. Learn more here: https://hubs.la/Q02LzY1T0 #SalesJobs #LifeScienceJobs #BostonJobs #ConsultingJobs #Hiring
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#QualityGovernance structures and processes provide insight to an organization’s leadership on how well their #QualityManagementSystem is functioning. Through the evolution of their Quality Management Review, organizations can ensure continuing suitability and effectiveness by assessing their performance quality. Discover the key steps in establishing effective quality governance: https://hubs.la/Q02Lvnwn0
Quality Governance and Evolution of Quality Management Review
hallorancg.com
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Embarking on the establishment of a culture of #quality requires a collective vision established by executives, alignment on organizational goals across the organization, and continual focus on collective responsibility for continuous improvement and innovation that sustains the culture. How do you build it and why does it matter? Read our point of view: https://hubs.la/Q02LlSGR0
Establishing a Culture of Quality: What Every CMO Should Know | Halloran Consulting Group
hallorancg.com