A full service Contract Research Organization

Offices in the San Francisco Bay Area and Sydney, Australia

All posts by inclin94403

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.

“The ever-changing landscape of the drug development space, which include increasingly rigorous regulatory requirements, is driving pharmaceutical and biotech companies to take a hard a look at their procedures and processes,” said Dr. Cruz. “Companies are actively embedding Quality throughout their development process to ensure that they are inspection-ready at all times. This training module will help educate drug development professionals on how to design, implement, and manage the highest quality TMF and ISFs as well as provide hands-on coaching on how to successfully organize, prepare, process and maintain these essential documents to facilitate successful regulatory inspections.”

To register for this event, click here: Module 082018: Trial Master Files (TMF) and Investigator Site Files (ISF)

Event Details:

Date: Wednesday, August 15, 2018 (8:00 am – 5:00 pm Pacific)
Venue: Stanford University, Faculty Club

Instructors:


Tony Cruz, Vice President of Quality


Scott McCulloch, Director of Clinical QA

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 through 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, as well as strategic consulting services. For more information feel free visit our website or contact us at our email address below.

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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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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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