Beaufort LLC

Nimble Approach to Partnerships Will Generate Value for CROs, Pharma

jpetit — Thu, 10 May 2012 20:47:58 +0000

This article in the April 26 ACRP Wire highlights a new study from ICON and Booz & Company that provides insight into how to successfully structure relationships between CROs and pharmaceutical companies. Read the study here.

High Standards

jpetit — Thu, 03 May 2012 14:15:13 +0000

In this Spring 2012 International Clinical Trials article, Beaufort’s John Wilson argues that clinical trial sponsors can reduce the total cost of quality by implementing a third-party quality oversight program. Read the entire issue here.

Quality by Design: Manufacturing Has It Right

jpetit — Tue, 01 May 2012 15:15:17 +0000

In this article from the May 2012 issue of the Journal of Clinical Research Best Practices, Beaufort’s John Wilson argues that clinical research can benefit from QBD. Pharmaceutical manufacturing established a risk-based approach to quality more than a decade ago, yet its adoption in clinical trials has been slow. As the pressure for fundamental change in clinical research quality continues to grow, we can learn much from our colleagues in pharmaceutical manufacturing.

“In the Patient’s Shoes” from Protocol to Publication

jpetit — Thu, 19 Apr 2012 18:20:18 +0000

In this April 2012 Monitor article, the authors posit that opportunities exist for sponsors and study teams to engage positively with potential and active trial participants by applying patient-centric principles to all stages of clinical trials.

Mature Approach

jpetit — Mon, 09 Apr 2012 15:13:04 +0000

In this Winter 2012 International Clinical Trials article, the authors underline the impact of risk and uncertainty in the bid process for CROs, and suggest that adopting a risk management strategy is the best way to overcome potential challenges.

Biotechnology Companies to Increase R&D Outsourcing with Overseas Shift

jpetit — Mon, 02 Apr 2012 02:32:13 +0000

An article in the March 15 ACRP Wire reports that a new survey from Booz & Company has found that more biopharmaceutical companies plan to outsource research and development and clinical trials and shift this work overseas. View the survey here.

Clinical Trial Oversight Summit

jpetit — Mon, 02 Apr 2012 02:24:36 +0000

The inaugural ClinicalTrial Oversight Summit is a four-day event featuring four co-located conferences:

June 4-5
Third Annual Mastering Clinical Trial Monitoring
Clinical Quality Risk Management Inaugural Event

June 6-7
Second Annual Clinical Auditing Forum
Vendor Management in Clinical Trials Inaugural Event

Beaufort’s John Wilson will present: “The Elements of an Effective GCP Quality System: Auditing, Monitoring, Training, Controlled Documents, Communication, and Governance”

Themes throughout the event will include risk-based approaches to clinical trial management, implementing quality systems-based approaches to GCP compliance, ensuring reliable study data, responding to the evolving regulatory landscape, and preparing sites and clinical research partners for inspection-readiness.

June 4-7, 2012
Omni Park House
Boston, MA

Drug Information Association – 48th Annual Meeting

admin — Wed, 14 Mar 2012 20:18:24 +0000

June 24 – 28, 2012
Philadelphia, PA
Website

The DIA 48th Annual Meeting is the pharmaceutical industry’s largest, longest running, best-value, global, multidisciplinary event. This year’s program offers learning opportunities for everyone and features the biggest names from industry, regulatory, and academia.

Beaufort’s John Wilson will present “Designing an Optimal Third-Party Quality Oversight Program” as part of the SIAC Showcase “Navigating the Intersection of Outsourcing and Quality Oversight.”

This showcase will explore regulatory expectations for managing service providers via well-defined project governance and oversight processes. Trends in the post-contract award process, including deliverable management and quality control where clinical trial sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors will be discussed. Explore various structures of governance and oversight and the outsourcing strategies they best support. In addition, panelists will make recommendations on ways to ensure the process is effective, efficient, and how to keep the operational teams focused on execution.

Schedule a meeting with us.

Beyond the Shadow of a Drought: The Need for a New Mindset in Pharma R&D

jpetit — Mon, 05 Mar 2012 16:56:41 +0000

This Oliver Wyman report highlights the fall in pharmaceutical R&D productivity in recent years and encourages the industry to rethink its current mindset.

MAGI’s Clinical Research Conference – 2012 East

jpetit — Thu, 23 Feb 2012 18:52:31 +0000

MAGI’s Clinical Research Conference covers sponsor operations, site operations, regulatory compliance, contracts, budgets and billing, quality and more. MAGI sessions and workshops emphasize practical tips based on real-life examples.

Beaufort’s John Wilson will present “Quality Systems for Sponsors, Sites and CROs.”

Hyatt Regency Crystal City
Arlington, VA
May 20-23, 2012