Pharmaceutical companies invest significant time, resources, and money in well-designed, carefully conducted and regulated clinical trials to determine the safety and effectiveness of new drugs and treatments. Regulatory agencies, such as U.S. Food and Drug Administration (FDA), control the conduction of clinical trials, describing good clinical practices (GCP’s) for studies with both human and non-human subjects. These guidelines ensure that the plethora of data coming from the clinical trials is generated according to the standard regulations and is, therefore, reliable.
One of the most critical points is to efficiently manage the supply of clinical products necessary to conduct the trial. Clinical trials are often conducted in multiple investigator sites worldwide; investigational compounds are becoming increasingly more complex and expensive; the number of participants often unpredictably changes among the different investigator sites. It is, therefore, quite a challenge to face this complexity and synchronize all the aspects involved in the supply process to ensure all subjects receive the proper treatment and avoid any waste of clinical products.
The Clinical Supplies Management module from STAEDEAN Life Sciences extends Microsoft Dynamics 365 Finance & Supply Chain Management with pharma-specific features required to plan, create, manage, control, and complete clinical trial protocols in compliance with GxP regulations. It also integrates seamlessly with the Master Planning module to streamline and directly interface clinical supplying processes with demand forecast and material resource planning (MRP), allowing a higher precision on the production and distribution of clinical products.
The Clinical Supplies Management module provides functionalities and workflows aiming to reduce paper-based processes and manage clinical trial protocols within Dynamics AX 2012. Among other features, the module introduces:
Definition of approved lists of compounds, programs, protocols, therapeutic areas, and placebos available for a selected product.
Definition of a list of sites, countries, therapeutic areas, projects, and other information for protocols.
Capability to record the maximum dose of a drug that can be safely administered per day.
The purpose of this user guide is to provide information regarding the setup of the Clinical Supplies Management module. The information in this document is only applicable to the STAEDEAN Life Sciences solution for Microsoft Dynamics 365 Finance & Supply Chain Management.