Clinical Research Courses - Customized to YOUR Needs

ANNUAL Good Clinical Practices Training

Feeling challenged with having the time to provide annual GCP training to your staff, teams and company that is informative, and engaging? Each year our training topics are expanded on for you as we are always CURRENT with regulations, guidelines, inspection experiences and regulatory authority communications to support your clinical programs - that focus on patient safety and reliability of trial results. Training can be provided in 1 , 2, 3, and 4 sessions to meet your organizations needs. Contact us TODAY!

Proposed Changes to ICH E6 Good Clinical Practices

This course equips you with identifying the future requirements proposed to jump start your companies readiness to implement the changes. Contact us TODAY!

ICH E8 General Considerations for Clinical Studies - Revision 1

This guideline provides direction on how to build a quality culture and HOW to implement ICH GCP E6 R2 Section 5.0 Quality Management (aka clinical trial risk management). This guideline and ICH GCP E6 R2 are 'aligned' to help the research industry to implement PROACTIVE quality management. Contact us TODAY!

Regulatory Authority Inspection Readiness Series

These courses address NUMEROUS regulatory authority inspections , that include but not limited to: FDA, EMA, MHRA, PMDA, CFDA, TGA, SAHPRA, and Health Canada. Is your regulatory authority inspectorate not listed here ? Please contact us here on the website as we have EXTENSIVE international inspection experiences. Contact us TODAY!

Good Clinical Practices Investigators and Sponsor-IND Responsibilities

Liz's background as a nurse and Research Nurse at Johns Hopkins Hospital brings a FOCUS on providing the training to support the development of working knowledge and skills. Liz's unique approach by providing training the lens of medical care, and the added protections of clinical research requirements for our patients and reliable trial results. Contact us TODAY!

Good Clinical Practices for Sponsors and CROs

This course equips staff with Sponsor, Investigator and Essential Documents working knowledge and skills of GCP for successful clinical programs. Liz's unique approach by providing training the lens of medical care, and the added protections of clinical research requirements for our patients and reliable trial results. Contact us TODAY!

CRO-Vendor Identification and Selection

Impactful CRO-Vendor Selection starts BEFORE the review of the Request for Proposal Response Reviews. Using a lifecycle approach, this course guides and equips you to regulator expectations for organizational effectiveness. This course focuses on a lifecycle approach combined with a robust framework that is reproducible and scalable. Also, regulatory authority inspection experiences will be presented. Contact us TODAY!

CRO-Vendor Oversight - Management

Impactful CRO-Vendor Management starts BEFORE the trial starts. This course guides and equips you to regulator expectations, understanding egulatory authority inspection experiences for organizational effectiveness. This course focuses on a lifecycle approach combined with a robust Vendor Oversight Management framework that is reproducible and scalable. CRO-Vendor Management Plan procedures, and template table of contents are provided during the course. Contact us TODAY!

Clinical Trial Risk Management

Using the ICH E6 GCP requirements, section 5.0, Quality Management, this course provides review of the requirements and HOW TO implement the requirements in a manner that 'fits' any size company, that is reproducible and scaleable. Contact us TODAY!

Clinical Trial Issue Management

Building upon the ICH E6 GCP requirements, section 5.0, Quality Management and section 5. 20 Management of Non-Compliance, this course provides review of the requirements and HOW TO implement the requirements in a manner that 'fits' any size company, that is reproducible and scaleable. Contact us TODAY!

What is Clinical Quality Management System and Why Should I Care?

In today's clinical trail environment, there is a need and requirement to stop planning and conducting clinical trials in silos. A comprehensive, organizational holistic approach is required to support clinical trials that focus on patient protection and reliable trial results. Using the TransCelerate BioPharma Clinical Quality Management System (cQMSP) Framework this course explains the components of a cQMS and how to implement for organizational effectiveness that is scaleable as the organization grow. Contact us TODAY!

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Please contact us here to send you a COMPREHENSIVE LISTING of our training course. Contact us TODAY!