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Investigator Initiated Trials (IIT) – Considerations and Guidance from the Perspective of Clinical Trial Supplies and GMP
18 June 2019
1 Introduction Conducting a clinical trial is a complicated process because of the many factors to address and the numerous entities involved. One...
Remote Observation Technologies in the Pharmaceutical Manufacturing Space
1 June 2018
1 Introduction Contemporary communications technologies, particularly those relating to the internet, have the potential to revolutionize...
Using SaaS in a Regulated Environment – A Life Cycle Approach to Risk Management
1 July 2017
1 Introduction In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. This...
Data Privacy: A Compliance Blind Spot
1 June 2017
1 Introduction What should be planned for when implementing a new computerized system, such as a clinical trial database? For clinical computerized...
Role of Process Capability in Monitoring Product Quality
12 May 2017
1 Introduction ASTM defines process capability as the natural or inherent behavior of a stable process that is in a state of statistical control,...
Leveraging PaaS in a Regulated Environment
1 July 2016
1 Introduction Over the past decade, the life sciences industry has seen cloud-based services and solutions evolve from a misunderstood technology...
Saas in a Regulated Environment: The Impact of Multi-tenancy and Subcontracting
1 July 2016
1 Introduction In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. Using...
Considerations for a Corporate Data Integrity Program
1 March 2016
Data integrity is a global expectation as evidenced by the Medicines and Healthcare Products Regulatory Agency (MHRA) guidance, published in January...
Improving Access for Patients with Unmet Medical Needs
1 June 2014
1 The Need for Access Point to any country on a map of the world. That’s where you might find a patient in urgent need of a new therapeutic option....
Validation & Data Integrity in eClinical Platforms
1 June 2014
1 Introduction It is well understood that each clinical trial is conducted and managed as an independent project even if several trials investigate...