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News & Events

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

By Steve Whittaker, Senior Consultant, The Avoca Group – 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 – 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 ( – 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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Webinar: Site/Sponsor/CRO Dynamics: Driving Quality and Productive Relationships

December 12, 2018 | 2:00pm - 3:00pm EST
This webinar will focus on leading practices within the AQC Knowledge Center that align with findings of Avoca/ACRP research. We will also share tools AQC Members have developed to help sites build or enhance their Quality Management System.

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Article: What Do Sites Really Want From Sponsors And CROs? ACRP/Avoca Survey Explains

Clinical 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 […]

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Webinar: TMF Inspection Readiness (IR): Avoiding IRregularities IRrespective of International Regulatory Agency

November 28, 2018 | 10:00am - 11:00am EST
Attend this webinar to learn about the various regulatory expectations of TMFs. Presented by Terry Endress.

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Webinar: Becoming a Sponsor/CRO of Choice: The Site Perspective

November 20, 2018 | 11:00am – 12:00pm EST
Avoca and ACRP will discuss results of industry research that showed what makes sponsors and CROs “partners of choice” with sites.
This Webinar will be hosted by Xtalks.

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Webinar: Biopharma Pre-competitive Collaboration: Delivering for Clinical Trial Excellence

November 12, 2018 | 11:00am – 12:00pm EST
The Avoca Quality Consortium will showcase the most frequently downloaded leading practices from its Knowledge Center (library of leading practices) and the most active online community discussions among Members.

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