Hero Banner of GCP, December 2-4, 2024


Logo of DArcy Compliance Consulting, We Build Compliance Cultures
DArcy Compliance Consulting is a is a Life Sciences Consulting Boutique that works exclusively with Life Science Start Ups and Small Companies helping them to establish and manage their quality management processes and systems.
Logo of Halloran

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.

Logo of InSeption Group

inSeption Group is a full-service global outsourcing organization built upon a foundational culture of exceptional service and quality.

This culture allows us to attract a subset of experienced quality assurance professional’s expert at establishing quality systems and streamlined approaches while reinforcing operational innovation in the changing landscape of clinical trials.

Taking personal responsibility, inSeption delivers as promised on the following activities:

  • Gap analysis investigation for companies or internal departments
  • Inspection Readiness and Mock Inspections
  • Developmental oversight of Quality Management Systems (QMS)
  • Internal and external auditing and compliance strategy planning and guidance
  • Vendor and site auditing on behalf of sponsors (and internally as part of our own QMS)
  • Development of required policies / SOP preparation /review / approval
  • Development and implementation of change and/or training programs of all quality-related aspects and metrics
  • Clinical quality oversight on behalf of a comp
Logo of Just in Time GCP

Just in Time GCP provides Consulting and Services support in areas of GCP Compliance, TMF Management, Clinical Technology, and Inspection Readiness. As an organization of 85+ employees, we bring a balance of technology, clinical operations, GCP, & records management experience to your organization. This expertise, combined with our core values of Quality, Collaboration, Accountability & Balance, makes us the ideal partner for optimizing your organizational commitment to compliance, process excellence, and inspection readiness.

Just in Time GCP has a long history of partnering with small, medium, and large pharma and biotech organizations. Our Services Group will support your organization with a diversity of projects including day to day TMF management, remediation, and inspection readiness reviews. Our Business & Technology consulting practice is your partner for clinical compliance, business process optimization and eClinical technology implementation, optimization, and support. We have an approach to inspection readiness that combines technology assessment and workshops helping you understand the story of your study and a TMF review that focus on both completeness and identification of GCP issues. If you are looking to implement or strengthen your Quality Management System, day to day management of TMF, clinical technology or GCP inspection readiness, we are your solution. Our consultants will partner with you to optimize your clinical processes to align with your business and growth strategy.

Logo of WCG Avoca

WCG Avoca is dedicated to improving quality and compliance in the clinical trial execution process. Integrating deep subject matter expertise with industry-leading approaches and technology, we tailor solutions that help companies build quality management, inspection readiness, and effective oversight systems into new or existing processes.

Visit: www.theavocagroup.com

Logo of WCG Avoca Quality Consortium

Gain an unbiased perspective, and have access to tools, templates, and leading practices needed to conduct clinical trials, while ensuring proactive quality management and inspection readiness.

Through participation in the WCG Avoca Quality Consortium (AQC), 200+ Member pharma, biotech, site, niche clinical service providers, and CRO organizations collaborate in a progressive, pre-competitive environment with the shared objective of elevating quality and bringing key stakeholders in the clinical trials process into greater alignment.

Members stay current on the latest challenges in the industry and have access to over 700 leading practices, tools, templates, dashboards, and process documents to assist with quality, risk management, and inspection readiness in clinical trial execution.

Visit: www.theavocagroup.com/quality-consortium/