This year, Avoca's research focuses on understanding industry actions toward adoption of ICH E6(R3), as well as impact on clinical trial design and execution, to foster collaboration and successful implementation.
Access The 2025 Avoca State of the Industry Report:
Understanding Adoption & Implementation of ICH E6(R3)
The survey is closed — thank you for participating!
Avoca, a WCG company, takes pride in providing the industry with insights into trends in clinical research to optimize the execution and quality of clinical trials. This year, our survey aims to understand opinions and experiences as it relates to the final ICH E6(R3) guidance.
This year, Avoca's research focuses on potential changes in regulatory guidance under ICH E6 (R3) to gain understanding of current awareness and perceived impacts among clinical trial stakeholders to navigate the path forward.
Access The 2024 Avoca State of the Industry Report:
Anticipating ICH E6 (R3): Awareness, Impact & Preparedness
The survey is now closed — thank you for your participation!
Avoca, a WCG company, takes pride in providing the industry with insights into trends in clinical research to optimize the execution and quality of clinical trials. This year, our survey focuses on potential changes in regulatory guidance under ICH E6 (R3). Importantly, you don’t need to be familiar […]
Health Care Compliance Association (HCCA) Report on Research Compliance Volume 20, Number 10 September 21, 2023 By Theresa Defino It’s not surprising that most people don’t hold informed—or strong beliefs about clinical trials—they’re what is termed “research-naïve,” meaning they have little or no personal experience with them. And so are most providers. […]
Read MoreThis year, Avoca's research analyzes across Sponsors, Providers, Site Staff, Patients, Physicians, and Investigators to determine alignment and explore motivators and deterrents of participation in clinical trials.
Access The 2023 WCG Avoca State of the Industry Report:
A 360° Assessment of the Clinical Trial Industry
The imperative to obtain a diverse body of clinical trial participants has been stressed in public statements for decades; however, parties executing clinical trials have remained insufficiently effective in addressing it. Understanding the patterns […]
Read MoreWCG's 360 Protocol Assessment™ is an integrated, turn-key solution that addresses ICH E8 R1 expectations and improves clinical trial predictability by providing sponsors with an operational risk and feasibility assessment of the protocol through the lens of multi-functional stakeholders [...]
Read MoreThe survey is closed – thank you for your participation!
WCG Avoca takes pride in providing the industry with insights into trends in clinical research to optimize the execution and quality of clinical trials. This year, our research looks to analyze across clinical research stakeholders […]
With the update of the Bioresearch Monitoring Program (BIMO) Sponsors and Contract Research Organizations Compliance Program Manual, FDA provides a comprehensive overview of inspection activities with significant revisions to Part III–Inspectional section […]
Read MoreBy Ed Miseta, Chief Editor, Clinical Leader - Walgreens recently became a member of the Avoca Quality Consortium (AQC), a community dedicated to improving clinical trials […]
Read MoreEach 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
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 […]
Read MoreSeptember 20, 2021
WCG Integrates WCG's Metrics Champion Consortium and WCG Avoca Quality Consortium, Creating Industry's Leading Forum for Clinical Trial Performance Metrics and Quality Management Knowledge Sharing
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
WCG Avoca's Crissy MacDonald, PhD, joins episode 17 of The Latest Dose Podcast by Oracle Health Sciences.
Read MoreLife 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 […]
Read MoreIn the May 2021 issue of International Clinical Trials, ICT interviews Steve Whittaker at WCG Avoca, who describes how the evolving regulatory landscape of the clinical trial industry stands to spur change in the way we manage data.
Read MoreThe 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, […]
Read MoreA consortium model of pharmaceutical players helps The Avoca Group change the clinical trial execution process
Read MoreSuccessful performance metrics focus on what drives success across the enterprise. They help answer important questions. They have a purpose. Don’t measure things simply because you can, or that aren’t a concern for your organization. That may sound obvious, but many organizations measure things that simply don’t matter. Just because something is a problem […]
Read MoreSponsors and ECG Core Labs need to effectively manage and track their resources, including people, time, and money, as each has an impact on productivity and efficiency over the course of a clinical trial. This case study demonstrates how Lilly and Quintiles utilized ECG Performance Metrics to have meaningful conversations around performance metrics to […]
Read MoreA clinical-stage biopharmaceutical company requested that Avoca 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 […]
Read MoreSince 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.” […]
Read MoreA clinical-stage global biopharmaceutical company with major hubs in the US and Japan requested that Avoca 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 […]
Read MoreBy 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, Avoca positioned the company for a successful regulatory inspection. Avoca not only delivered clear and actionable findings; it helped the client design and execute a remediation strategy. To download the […]
Read MoreAs 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 […]
Read MoreAugust, 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 […]
Read MoreApril 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 […]
Read MoreJune 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.
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.
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.
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 […]
Read MorePress 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 […]
Read MoreInc. magazine today revealed that The Avoca Group has been placed on its annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies. The list represents a unique look at the most successful companies within the American economy’s most dynamic segment—its independent small businesses. […]
Read MoreThe Avoca Group announced the agenda for its 2020 Avoca Quality and Innovation Summit. The event, which will be held virtually on October 14–15, will explore the role of quality as the foundation of clinical trials and the need for innovation in study execution. Across two days of interactive sessions, panel discussions, and workshops, attendees […]
Read MoreEach 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:
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:
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 […]
Read MoreJune 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.
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 […]
Read MoreMarch 6, 2020
Washington, DC – The Association of Clinical Research Professionals (ACRP) and The Avoca Group will jointly recognize leading Sponsors and CROs at the ACRP Awards & Recognition Ceremony on Friday, May 1, during the ACRP 2020 annual conference in Seattle, Washington.
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 […]
Read MoreJanuary 9, 2020 – GLOBE NEWSWIRE PRINCETON, NJ – A new report from Tufts Center for the Study of Drug Development establishes benchmarks for the vendor qualification process, a critical element of clinical trial set up and execution. According to its November/December Impact Report, the process volume and complexity of the vendor qualification process creates […]
Read MoreNovember 14, 2019 - Tufts CSDD Study Identifies Opportunities for Drug Sponsors to Optimize Vendor Selection
Read MoreNovember 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 […]
Read MoreSeptember 13, 2019 – Applied Clinical Trials – Dennis Salotti, COO, The Avoca Group – Each year, The Avoca Group invites clinical trial professionals from sponsor and provider organizations to participate in research on prescient industry topics and to provide key benchmarks on the current state of clinical outsourcing. For this year’s report, Avoca analyzed data […]
Read MoreAugust 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 […]
Read MoreAugust 15, 2019 – ClinicalLeader.com – By Dennis Salotti, COO, The Avoca Group – Our global digital population – people around the world that are active internet users – has grown to 4.3 billion as of July 2019, representing roughly 56 percent of the global population. […]
Read MoreSo often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate—or even eliminate—the pain points associated with preparing […]
Read MoreMay 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 […]
Read MoreExamines 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 […]
Read MoreMay 9, 2019 – Princeton, NJ – (BUSINESS WIRE) – The Avoca Group announced today that David Shing, Verizon Media’s Digital Prophet, will deliver the keynote address at the 8th Annual Avoca Global Summit. David will discuss current and future trends in the evolving digital landscape, including how the rapid adoption of technology will advance […]
Read MorePress 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 […]
Read MorePress 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 […]
Read MoreBy 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 […]
Read MoreMarch 19, 2019 – Princeton, NJ – The Avoca Group today announced the preliminary agenda for its 8th Annual Avoca Global Summit to be held June 5-6 at the Boston Harbor Hotel in Boston, MA. […]
Read MoreBy 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 […]
Read MoreBy 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 […]
Read MoreTORONTO, 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 […]
Read MoreClinical Leader – December 6, 2018 A conversation with Jim Kremidas of ACRP and Dennis Salotti of The Avoca Group The Association of Clinical Research Professionals (ACRP) and The Avoca Group surveyed nearly 300 clinical trial study site staff earlier this year to determine the most important factors for advancing quality in studies from […]
Read MoreOctober 26, 2018 — In early 2018, The Avoca Group and the Association of Clinical Research Professionals (ACRP) collaborated on web-based survey research to evaluate the key attributes that drive quality in clinical trials from the site perspective. In the research, investigational sites were asked to rate sponsor and CRO attributes (including responsiveness to questions, […]
Read MoreOctober 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 […]
Read MoreBy 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 […]
Read MoreBy 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 […]
Read MorePress Release – June 13, 2018 Princeton, NJ. The Avoca Group announced today that it has launched the Diligent® Qualification Platform, the clinical research industry’s first centralized platform for vendor qualification as well as eLuminate™, an online […]
Read MorePress 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 […]
Read MoreBy Dennis Salotti, COO, The Avoca Group Clinical Leader – May 1, 2018 Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process. Specifically, ICH […]
Read MorePress 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 […]
Read MorePress 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 […]
Read MoreBy 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 […]
Read MoreBy Andrew Burrows, KNect365 KNect365 Life Sciences – March 14, 2018 KNect365 spoke to Patricia Leuchten, President and CEO at The Avoca Group, as part of PCT TV at Partnerships in Clinical Trials Europe (Nov 2017) about how the clinical trials industry should interpret the ICH E6 R2 guidelines and the biggest challenges to […]
Read MorePress Release – March 13, 2018 Princeton, NJ – The Avoca Group announced today that it will unveil the Diligent® Qualification Platform as well as eLuminate™, an e-learning platform, at the 7th Annual Global Quality Summit 13-14 June 2018, at the Hotel Intercontinental in Dublin, Ireland. Sponsored by the Avoca Quality Consortium® (AQC), a Member-based […]
Read MorePress 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 […]
Read MorePress 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 […]
Read MorePress Release – December 7, 2017 Washington, DC – The Association of Clinical Research Professionals (ACRP) and the Avoca Quality Consortium® (AQC) will host the first-ever ACRP-AQC Quality Congress in conjunction with ACRP 2018. The 2018 Quality Congress will kick off the leadership track at ACRP 2018, the premier education and networking event for […]
Read MoreBy Dennis Salotti, Vice President of Operations, The Avoca Group Outsourcing-Pharma.com – December 5, 2017 Making the shift in the pharmaceutical industry from a risk-averse approach to overseeing clinical trials to a risk-based approach is – quite frankly – earthshaking. The tremors are being felt by sponsors and providers alike. The fact is, we are […]
Read MoreAugust 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.
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.
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 […]
Read MoreMay 31, 2017
Applied Clinical Trials
By: Denise Calaprice, PhD, Senior Consultant, The Avoca Group
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.
Read MoreThe 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.
Read MoreAvoca research on medical device clinical outsourcing trends cited in Med Device Online.
Read MoreAvoca data cited in Applied Clinical Trials article 'Shifting Monitoring Paradigms: Challenges and Opportunities, Sponsor-site alignment on risk-based approaches is critical if clinical trial standards are to reach new levels.'
Read MoreThe 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.
Read MoreBy 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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