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InClin Announces Quasar Publication Featuring First Virtual Inspection Conducted by the European Medicines Agency (EMA)


SAN MATEO, Calif.–(BUSINESS WIRE)–January 19, 2021– InClin, Inc., a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney Australia, today announced the publication of a manuscript entitled: “The New Norm: A Global Virtual GCP Preapproval EMA Inspection” in Issue #154 January 2021 edition of Quasar, the Research Quality Association’s (RQA) quarterly journal.

The article describes how the European Medicines Agency (EMA) and sponsor collaborated to successfully complete a global, fully virtual, and remote EMA inspection., the first of its kind. Ultimately, a robust plan, flexibility, and innovative use of appropriate resources, logistics, and electronic tools were key components of the successful EMA inspection and led to a Conditional Marketing Authorization.

“The publication of our manuscript by such an esteemed journal highlights the continued hard work and dedication of many men and women to develop and provide innovative, desperately needed, and life-saving therapies to patients in spite of the disruption the COVID-19 pandemic has caused in our daily lives,” said Tony Cruz, DVM, Senior Vice President, Quality Assurance. “We hope that this article serves as a road map for drug development companies who share a similar dedication to patients and the development of novel, life-saving therapies.”

For a copy of the article, please go to www.inclin.com/news/.

For information about Quasar, including obtaining a copy of Issue #154 January 2021 edition please go to www.therqa.com.

About InClin
InClin is a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney, Australia. We are a single source provider of an integrated full suite of clinical development services from Phase 1 to Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, and strategic consulting services. For more information visit www.InClin.com or contact us at busdev@inclin.com.

Contact:
Bianca Nery
Office Phone: (650) 376-4086
Email: bnery@inclin.com

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Tara Weihmiller Joins InClin as Vice President of Clinical Operations

SAN MATEO, Calif.–(BUSINESS WIRE)–APRIL 2, 2019– InClin, Inc., a full-service Clinical Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney Australia, today announced the appointment of Tara Weihmiller as Vice President of Clinical Operations. Ms. Weihmiller will be responsible for managing clinical staff and developing initiatives to support operational excellence. Additionally, Ms. Weihmiller will provide strategic direction for InClin and provide direct oversight on key clinical studies across various indications, including oncology.

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InClin’s GCP and QA Team to Instruct Trial Master Files and Investigator Site Files Training Module

InClin is pleased to announce that Tony Cruz, InClin’s Vice President of Quality, and Scott McCulloch, InClin’s Director of Clinical Quality Assurance, will be participating as instructors in a training module hosted by The Academy of GCP entitled “Module 082018: Trial Master Files (TMF) and Investigator Site Files (ISF)” on Wednesday, August 15, 2018 at Stanford University. This module is designed to educate Clinical Research Professionals on how to design, implement, and manage the highest quality Trial Master Files (TMF) and Investigator Site Files (ISF). In addition, this module will provide hands-on coaching on how to successfully organize, prepare, process and maintain these essential documents to facilitate successful regulatory inspections.

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Webinar on Achieving TMF Excellence: CRO and Sponsor Partnerships

Regulatory Agencies throughout the world are becoming increasingly critical and demanding of Trial Master File management and Vendor oversight. New industry guidelines, such as ICH-GCP E6 R2, are also impacting the way clinical trials are managed and executed. With this in mind, InClin and GSK are excited to announce their CRO and Sponsor Partnerships webinar!

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InClin Celebrates its 20th Anniversary and New Office Space Facility

InClin is turning 20 this month!  We are excited to announce that InClin has a reached a milestone, celebrating 20 years of business as both a Functional Service provider and CRO. During this time, InClin has expanded significantly, employing over 125 people across two continents.  InClin has also grown its suite of service offerings in the last two decades, with the capability of now providing full-service support for Phase 1-4 studies, including project management, clinical operations, regulatory and essential document management, data management, biostatistics, medical writing, medical monitoring, drug safety, and quality assurance services.

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InClin Announces Office Relocation and Expansion in North Sydney, Australia

InClin Pty Ltd. is pleased to announce the opening of our new office in Australia; located at 25 Berry Street – No. 210 – North Sydney, Australia.

The new office demonstrates InClin’s continued commitment and investment in having a strong and visible presence in the region. InClin and InClin Pty Ltd have seen exciting growth in 2017 and having this expansion will only strengthen our company and allow us to continue that momentum into 2018.

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Dr. Charles Du Mond Joins InClin as Senior Vice President of Biometrics

InClin is pleased to announce that Charles Du Mond, PhD, has joined InClin as the Senior Vice President of Biometrics. In this role, Dr. Du Mond will review all InClin biometrics work products and be responsible for providing therapeutic area and technical expertise with respect to the development of the protocol, data collection, and conduct of the statistical analyses.

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InClin Announces Participation in Barnett International Publication of Good Clinical Practice, A Question and Answer Reference Guide – May 2017

InClin is pleased to announce that Good Clinical Practice, A Question and Answer Reference Guide – May 2017, Section 1, “GCP Regulations, Standards, and Guidelines for Clinical Research,” was reviewed and edited by Tony Cruz, DVM, InClin’s Vice President of Quality Assurance.  This industry-leading GCP Question and Answer reference guide published by Barnett International is a key resource regarding the interpretation and implementation of US and international GCP standards for drugs, biologics and medical device clinical trials. The publication includes peer-reviewed, current and up-to-date overview of questions and answers regarding regulations, regulatory compliance guidance, and other topics to provide global regulatory compliance awareness with good clinical practice standards internationally.

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