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News & Events Category: Articles

2021 Avoca Industry Report: Diversity in Clinical Research

Each year, WCG Avoca surveys industry professionals to understand trends in clinical development, with a particular focus on outsourcing dynamics and relationships between research Sponsors and Providers.
Access The 2021 WCG Avoca State of the Industry Report: Diversity in Clinical Research Execution and Participation

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Article: Diversity In Clinical Research Execution And Participation

Life Science Leader - By Denise Calaprice, Ph. D., Senior Consultant, WCG Avoca - The events of the past two years created an urgent and nonnegotiable imperative to increase diversity in clinical research: diversity both in how such studies are executed, and in the types of patients recruited for participation […]

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2020 Avoca Industry Report: Innovation and Diversity

Each year, WCG Avoca surveys industry professionals to understand trends in clinical development, with a particular focus on outsourcing dynamics and relationships between research Sponsors and Providers.
Access The 2020 Avoca State of the Industry Report: Innovation by Fire, Diversity, and the Next Normal

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Article: How CRO-Sponsor Partnerships Spurred Innovation In 2020

Life Science Leader - By Denise Calaprice, Ph. D., Senior Consultant, WCG Avoca - For decades, operational progress within the clinical research industry has been profoundly shaped by the relationships between sponsor companies and their CRO partners. Among other advances, these relationships have contributed to sponsors’ abilities to globalize clinical trial operations, expand […]

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News Release: WCG Acquires The Avoca Group

The Avoca Group strengthens WCG’s position as an industry leader for accelerating clinical trial quality management and compliance transformation. WCG™, a leading provider of clinical trial solutions, announced its acquisition of The Avoca Group, a life sciences consulting firm supporting biopharma, biotech, CROs and clinical service providers, […]

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Quality Management System for a Clinical-Stage Biopharmaceutical Company

A clinical-stage biopharmaceutical company requested The Avoca Group perform an in-depth review and assessment of its Quality Management System (QMS). The project objectives were to identify and document gaps and to provide guidance in the design and development of a comprehensive QMS that would complement the company’s existing QMS. The company also requested that Avoca […]

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SOP Review for a Clinical-Stage Biopharmaceutical Company

Since the release of ICH (E6) R2 in 2017, clinical research companies have been taking active measures to ensure compliance with its new guidance which, “encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results.” In […]

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CQMS Consulting Project for a Clinical-Stage Biopharmaceutical Company

A clinical-stage global biopharmaceutical company with major hubs in the US and Japan requested The Avoca Group perform an in-depth review and assessment of its Clinical Quality Management System (CQMS) with a special focus on Vendor Oversight, Risk Management, Technology Business Requirements, and Quality Tolerance Limits (QTLs). The project objectives were to identify and document […]

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Not Just A Mock Inspection: With Storyboarding, WCG Avoca Gives Pharma Client the Insight and Tools for a Successful Regulatory Inspection

By providing a mid-sized pharmaceutical client with more than a standard mock inspection and having the agility to pivot as the client’s needs changed, WCG Avoca positioned the company for a successful regulatory inspection. WCG Avoca not only delivered clear and actionable findings; it helped the client design and execute a remediation strategy. To download […]

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Mock Inspection Consulting Project for a Clinical-Stage Biopharmaceutical Company

As the GCP landscape continually evolves, sponsors are encouraged to pursue innovative approaches. Mock Inspections are a critical tool to ensure inspection readiness and a quality control step to confirm that the innovative approaches are being implemented in a regulatorily compliant way. Inspection Readiness needs to keep pace with this philosophy and to be proactive, […]

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Standardized Metrics for Better Risk Management: The Right Data at the Right Time

August, 2016 Just because information can be gathered and shared more quickly among stakeholders does not mean that it can identify risk. This article describes the need for pharma to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as tools for tracking and predicting performance. The proliferation of cloud-based technologies has made it […]

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Importance of Data Entry Timeliness

April 7, 2017 The pharma industry agrees that the importance of entering data into an EDC as soon as possible following a subject is paramount. Slow site data entry can impact the credibility and usefulness of centralized monitoring data analytic reports. But MCC survey indicates poor oversight undermines ability to monitor study quality With the […]

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Finally, Standardized KPIs are Front and Center

June 15, 2020 - CenterWatch
With the International Council on Harmonization (ICH) poised to begin work on another revision to its good clinical practice (GCP) guideline, ICH E6, sites and sponsors have questions about what they can expect from upcoming changes while they still are struggling to interpret requirements placed on them by the previous 2016 revision. See insights provided by Steve Whittaker, Senior Consultant of The Avoca Group.

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Aligning Data Entry and Site Payment Incentives For Clinical Trials and Patients

June 15, 2020 - CenterWatch
With the International Council on Harmonization (ICH) poised to begin work on another revision to its good clinical practice (GCP) guideline, ICH E6, sites and sponsors have questions about what they can expect from upcoming changes while they still are struggling to interpret requirements placed on them by the previous 2016 revision. See insights provided by Steve Whittaker, Senior Consultant of The Avoca Group.

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Bridging the Gaps in CAPA Planning in Clinical Trials

June 15, 2020 - CenterWatch
With the International Council on Harmonization (ICH) poised to begin work on another revision to its good clinical practice (GCP) guideline, ICH E6, sites and sponsors have questions about what they can expect from upcoming changes while they still are struggling to interpret requirements placed on them by the previous 2016 revision. See insights provided by Steve Whittaker, Senior Consultant of The Avoca Group.

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Novo Nordisk Receives First Place in ACRP-Avoca Sponsor Quality Awards

Press Release – September 30, 2020 Novo Nordisk was recognized with the ACRP-Avoca Sponsor Quality Award during the ACRP-Avoca Quality Congress this month. The Association of Clinical Research Professionals and The Avoca Group jointly recognized leading sponsors at the event. The following ACRP-Avoca Sponsor Quality Awards were announced: First Place – Novo Nordisk Second Place […]

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Covance Receives First Place in ACRP-Avoca CRO Quality Awards

Press Release – September 30, 2020 Covance was recognized with the ACRP-Avoca CRO Quality Award during the ACRP-Avoca Quality Congress this month. The Association of Clinical Research Professionals and The Avoca Group jointly recognized leading CROs at the event. The following ACRP-Avoca CRO Quality Awards were announced: First Place – Covance Second Place – ICON […]

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2019 Avoca Industry Report: Quality Oversight

Each year, The Avoca Group surveys industry professionals to understand trends in clinical development, with a particular focus on outsourcing dynamics and relationships between research Sponsors and Providers. Access The 2019 Avoca State of the Industry Report: Quality Oversight in Clinical Outsourcing

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2019 Avoca Industry Report: Clinical Outsourcing

Each year, The Avoca Group surveys industry professionals to understand trends in clinical development, with a particular focus on outsourcing dynamics and relationships between research Sponsors and Providers. Access The 2019 Avoca State of the Industry Report: Clinical Outsourcing Spend & Key Relationship Measures

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Article: How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19

July 7, 2020 – Clinical Leader – By Mai Nguyen, Senior Consultant, The Avoca Group – In clinical research, we learn to act instinctively and quickly when it comes to making decisions about subject protection, data validity, and ethical conduct. That skillset inherently comes with the ability for problem-solving with a focused determination on the patient. The […]

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Article: Ask the Experts – Keeping Up with ICH E6 Changes

June 15, 2020 - CenterWatch
With the International Council on Harmonization (ICH) poised to begin work on another revision to its good clinical practice (GCP) guideline, ICH E6, sites and sponsors have questions about what they can expect from upcoming changes while they still are struggling to interpret requirements placed on them by the previous 2016 revision. See insights provided by Steve Whittaker, Senior Consultant of The Avoca Group.

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COVID-19 CEO Letter

March 25, 2020 – This is an update on how we are addressing the needs of Avoca’s clients and Quality Consortium Members, and the companies that we are working with as part of the Diligent® Qualification Platform, given the extraordinary circumstances that we face with COVID-19. The Avoca Group Operations Avoca and its global team of experts have […]

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Article: Clinical Development Vendor Qualification: “Check-The-Box” Exercise?

March 4, 2020 – Contract Pharma – Jay A. Turpen, Senior Consultant, The Avoca Group – Key first steps to vendor risk management. Are your company’s clinical development vendor qualification (VQ) activities a “Check-The-Box” exercise because someone said that regulators expect it? Or are your VQ activities a comprehensive first step in managing the risk […]

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Article: The Spirit of Radical Integration

November 2019 In the Spotlight article published November 2019 by International Clinical Trials, Patricia (Patty) Leuchten, Founder and CEO of The Avoca Group, reflects on the challenges associated with managing risks and designing quality into clinical trials; the work the Avoca Quality Consortium® has done to bring together industry experts from pharma, biotech, and CROs […]

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Article: What Do Sponsors And CROs Think About Technology Use In Trials?

August 26, 2019 – ClinicalLeader.com – Ed Miseta, Chief Editor, Clinical Leader – Each year, The Avoca Group surveys industry professionals to understand trends in clinical development. The surveys place a particular focus on outsourcing dynamics and relationships between sponsor companies and service providers. For one of its most recent surveys, Avoca examined what sponsors and […]

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News Release: Avoca Quality Consortium and Longboat Clinical Partner to Deliver Clinical Trial Site Quality Management System (QMS) Tools to Industry Sponsors

May 29, 2019 — Dublin, Ireland — AP News — Longboat Clinical is pleased to announce a new partnership with the Avoca Quality Consortium (AQC) to make an extensive suite of quality management tools available to hospitals and clinics participating in clinical studies. The AQC, a precompetitive collaborative comprised of nearly 100 pharma, biotech, CRO, and […]

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News Release: Tufts CSDD Study on the Vendor Qualification Process

Examines vendor qualification process, company experience managing this process and ways that it can be improved May 15, 2019 – Contract Pharma – The Center for the Study of Drug Development, an independent, academic, non-profit research group within Tufts University School of Medicine, in collaboration with the Avoca Group, is conducting a survey examining the vendor […]

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Roche/Genentech Receives First Place in ACRP-Avoca Sponsor Quality Awards

Press Release – April 13, 2019 Washington, DC – Roche/Genentech was recognized with the ACRP-Avoca Sponsor Quality Award yesterday during the ACRP-Avoca Awards and Recognition Ceremony taking place at the ACRP 2019 annual conference. The Association of Clinical Research Professionals and The Avoca Group jointly recognized leading sponsors at the event. The following ACRP-Avoca Sponsor […]

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PPD Receives First Place in ACRP-Avoca CRO Quality Awards

Press Release – April 13, 2019 Washington, DC – PPD was recognized with the ACRP-Avoca CRO Quality Award yesterday during the ACRP Awards and Recognition Ceremony taking place at the ACRP 2019 annual conference in Nashville. The Association of Clinical Research Professionals and The Avoca Group jointly recognized leading CROs at the event. The following […]

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Article: Biopharma Precompetitive Collaboration: Optimizing Clinical Trial Quality, Efficiency, and Excellence

By Steven B. Whittaker and Janis L. Hall, The Avoca Group ClinicalLeader.com – April 11, 2019   Developing new, innovative pharmaceutical agents to address global health needs is becoming more complex, challenging, and costly. As the industry attempts to adapt and gain value for patients, healthcare providers, and other stakeholders, technologies, digitization, real-world data, immediate […]

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Article: Taking Control Of Clinical Quality Tolerance Limits In Clinical Trials

By Steve Whittaker, Senior Consultant, The Avoca Group ClinicalLeader.com – January 8, 2019   The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) regulations have created a buzz within the industry regarding newly required expectations for quality tolerance limits (QTLs) when conducting good clinical practice (GCP) clinical trials. QTLs […]

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Article: Embracing the present and owning the future in clinical trial execution

By Crissy MacDonald, PhD, Executive Director, Client Delivery, The Avoca Group Outsourcing-Pharma.com – December 13, 2018   2018 was a pivotal year for the pharmaceutical industry and the execution of clinical trials. In November 2016, for the first time in more than 20 years, the ICH E6 Good Clinical Practice (GCP) Guideline was amended, and […]

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Quality Tolerance Limits as Required by ICH E6(R2): Definitions and Requirements for “Fit-For-Purpose” Compliance, New Webinar Hosted by Xtalks

TORONTO, December 13, 2018 (Newswire.com) – Expectations for quality tolerance limits when conducting Good Clinical Practice (GCP) clinical trials in accordance with ICH E6(R2) have generated a buzz in the industry. Quality tolerance limits have historically been required for Good Manufacturing Practice (GMP) activities, inferring limits by which significant actions must be taken to ensure the manufactured product achieves quality and usability limits. With regulators now […]

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News Release: The Avoca Group Joins BlueCloud Global Networking System

October 16, 2018 — BlueCloud by HealthCarePoint (HCP), a Texas-based healthcare and clinical research networking-technology company founded by patient-survivors, and The Avoca Group, Inc., a life sciences consulting firm dedicated to improving quality and compliance in the clinical trial execution process, today announced its mutual collaboration […]

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Article: New ICH Guidelines Address Industry Inefficiency

By Crissy MacDonald, PhD, Executive Director, Client Delivery, The Avoca Group Applied Clinical Trials – August 23, 2018   Although the pharmaceutical industry has always incorporated risk-based processes, the ICH E6 (R2) addendum now mandates that clinical trial operations also include risk-based approaches. Based on the latest research, and The Avoca Group’s experience helping companies […]

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Clinical Trials: Not Broken, But In Need Of Repair

By Ed Miseta, Chief Editor, Clinical Leader Clinical Leader – July 9, 2018   We all know the days of Big Pharma companies launching billion-dollar blockbuster drugs are generally behind us. Today, novel new therapies are harder to bring to market. Trials are costly, take a long time to complete, and too many of them […]

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Announcing Speaker Lineup for the 7th Annual AQC® Global Quality Summit

Press Release – May 23, 2018 Princeton, NJ – The Avoca Group has announced the full speaker lineup for the 7th Annual AQC® Global Quality Summit, taking place 13-14 June 2018 in Dublin, Ireland. The theme for this year’s event – Embrace the Present. Own the Future. – focuses on today’s most innovative solutions for […]

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Medpace Receives First Place in ACRP-Avoca CRO Quality Awards

Press Release – April 27, 2018 Medpace was recognized with the first-ever ACRP-Avoca CRO Quality Award today during the ACRP-Avoca Awards and Recognition Ceremony taking place at the ACRP 2018 annual meeting. The Association of Clinical Research Professionals and The Avoca Group jointly recognized leading CROs at the event. The following ACRP-Avoca CRO Quality Awards […]

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Abbott Laboratories Receives First Place in ACRP-Avoca Sponsor Quality Awards

Press Release – April 27, 2018 Abbott Laboratories was recognized with the first-ever ACRP-Avoca Sponsor Quality Award today during the ACRP-Avoca Awards and Recognition Ceremony taking place at the ACRP 2018 annual meeting. The Association of Clinical Research Professionals and The Avoca Group jointly recognized leading sponsors at the event. The following ACRP-Avoca Sponsor Quality […]

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Article: A Practical Framework For Assessing Risk In Clinical Trials

By Cristin MacDonald, PhD, Executive Director of Client Delivery, The Avoca Group Clinical Leader – March 15, 2018   The purpose of a comprehensive assessment system is to support structured, systematic, objective, and rational decision making. This holds true even when assessing something as difficult to pin down as risk. The Avoca Quality Consortium (AQC) takes […]

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ACRP and The Avoca Group Announce Finalists for CRO and Sponsor Quality Awards

Press Release – March 13, 2018 The Association of Clinical Research Professionals (ACRP) and The Avoca Group will jointly recognize leading Sponsors and CROs at the ACRP/Avoca Awards & Recognition Ceremony on Friday, April 27, during the ACRP 2018 annual meeting. Finalists for the ACRP-Avoca Quality Awards were chosen by investigational sites through a research […]

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The Avoca Group Transforms the Clinical Trial Execution Process by Introducing a Data-Driven, Time-Saving Solution for Vendor Prequalification

Press Release – December 19, 2017   Princeton, NJ – The Avoca Group today announced a new platform to accelerate the prequalification of clinical service providers by leveraging analytics-driven technology and industry-leading standards to provide rapid, intelligent access to in-depth RFI questionnaires. The Diligent® Prequalification Platform furthers the work Avoca has become known for over […]

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Article: Patricia Leuchten, Founder and CEO, The Avoca Group, is guest columnist for Clinical Leader

August 17, 2017
The article entitled, “The Changing Landscape Of Clinical Trials: How Leaders Should Respond” addresses the changing landscape of clinical trials. Mergers and acquisitions, new players, the rapid proliferation of technology, increased patient advocacy, and new regulatory guidelines have added to the complexity of trials and burdened resource-strapped leaders with additional challenges and risks.

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Article: Best Practice on Outsourcing Clinical Trials

Irish Medical Times interviews Patty Leuchten, founder and CEO of The Avoca Group August 15, 2017

June Shannon, writer for the Irish Medical Times, spoke with Patty Leuchten, founder and CEO of the Avoca Group, during recent AQC Summit in Dublin, about the growth in outsourcing clinical trials.

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ACRP and The Avoca Group Announce Strategic Partnership to Drive Quality and Collaboration in Clinical Research

Press Release – August 8, 2017   The Association of Clinical Research Professionals (ACRP) and The Avoca Group today announce a new strategic partnership aimed at driving quality, standardization, and collaboration in clinical research. The Avoca Group, whose clients include top five pharmaceutical companies and global contract research organizations (CROs), is a driving force behind […]

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Avoca Listed in the 2015 Inc. 5000

Inc. 5000, an exclusive ranking of the nation's fastest-growing private companies. Avoca’s three-year sales growth of 165% earned the company its spot in the top 50% of the list.

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Quality Of Outsourced Trials: Why Do Disconnects Still Exist Between Sponsors And CROs

The requirement for quality during the conduct of clinical trials is an absolute; a given that few in the pharmaceutical, biotech, and CRO industries would debate. Yet longitudinal survey data collected by The Avoca Group highlight that disconnects - the definitions of what constitutes quality, alignment on required levels of quality, and success at delivering to these expectations - continue to exist.

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Managing Clinical Development Risk: Pharma and CRO Report

The Avoca Group conducted a survey in 2013 to examine sponsor and provider practices and perceptions with respect to the management of risk in outsourced clinical trials (1). The survey specifically explored questions regarding the use of, challenges associated with, and benefits gained from various risk-sharing models, formal risk assessment and management approaches, and approaches to risk-based monitoring.

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Want To Create A Culture Of Quality?

By Ed Miseta, Chief Editor, Clinical Leader: At this year’s Quality Consortium Summit, hosted by pharma consulting firm The Avoca Group, Chris Hilton, VP of Development and Clinical Alliance Management for Pfizer Inc., shared his a-ha moment on the importance of quality. “It was the week I became head of operations and received an FDA warning letter just seven days later,” he said. “It caused me to look at things very differently. There is no question we need to build transparency between everyone involved in the clinical trial process. For most of us it will involve a different way of looking at the world.”

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