This course provides an overview of data integrity. As our data sources change, with decentralized trials and external data being used more in the clinical…
Within Clinical Data Management our ultimate goal is to ensure that all data collected within a clinical study is clean, clear, concise and appropriate. This…
Regulatory authorities require cardiac safety data to be collected during all clinical phases of the development of a new drug. This module will explain the…
Standard Operating Procedures (SOPs) are guidelines which are instaIled by an organisation to ensure the consistent approach by those involved to that organisation’s activities. Within…
In today’s clinical trial environment with the increasing adoption of technology, roles are changing and a good understanding of clinical data management tasks is critical…
Preparing for Regulatory Inspections Course. This course provides an overview of the critical preparation tasks required to ensure your inspection achieves the best possible outcome…
RECIST for Data Mangers This course provides data management professionals with the background and explanation of what RECIST is; and practical experience and recommendations for…
This course provides an overview of risk based monitoring. In today’s clinical trial environment with the adoption of technology, traditional onsite monitoring with 100% SDV…
For data managers laboratory data can prove to be frustrating, complex and time consuming. This course gives an explanation of what laboratory data consists of,…
Understanding the Clinical Pharmacology of an Investigational Medicinal Product, is fundamental in drug development. Pharmacokinetics is a a branch of Clinical Pharmacology with the aim…
For data managers, laboratory data can prove to be a frustrating, if not bewildering, subject with unrivalled subtleties and pitfalls. This book sets out to…
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