In recent years, Clinical Trials in most indications have increased in scale and complexity. The pharmaceutical industry is facing new challenges on a daily basis as regards manufacture and distribution, framed by increasingly stricter regulations.
The right medication, the right amount, the right time, the right patient. These are the principal objectives to be met in order to increase the cost effectiveness of a Clinical Trial. Complying with regulations, guaranteeing the quality of the product and carrying out an effective distribution of the trial results in a greater benefit for all the parties involved: patient, society and industry.
A clinical trial is a research project aimed at answering specific questions about vaccines or new therapies or new usage forms for treatments which are already known. Clinical trials are used to determine whether new products or treatments are effective as well as beneficial to health.
The life cycle for the use of medicines is limited (patents), so investment in new products is the basis of success and sustainability for companies in the pharmaceutical industry.
Supply Chain in Clinical Trials
The R & D organisations configure clinical projects from chemical / pharmaceutical / biological development, clinical packaging up to delivery to the hospital / researcher.
An effective supply chain for clinical trials relies heavily on providing supplies for the study to several hospitals (sites) so that the prescribed medications are administered at the right times throughout the study. In the event of an “exhaustion of the supply”, patients who use the medication may be disqualified and the entire clinical trial may be compromised. The relationship with the hospital / researcher could be affected.
However, a clinical trial supply chain has unique requirements, such as “blind medications” and different dosage strengths. A “blind medication” has a different treatment depending on its serial number. It is necessary to produce a range of different dosages in order to support the study experiment.
For many pharmaceutical companies, integrating this “business” within their commercial aspect is complicated.
The main Supply Chain areas to be covered:
- Planning: Manage demand starting from Trial planning up to the last visit of the last patient
- Provision: Consolidated purchases in all the company’s Trials
- Manufacturing: Streamline all packaging and labelling processes
- Quality Control: Manage certificates for open and blind studies. Ensure compliance with growing regulatory demands
- Supply: Harmonise management and distribution. Provide a reliable and robust service to researchers and patients
How does SAP help us to meet all these challenges?
SAP is the appropriate tool for the efficient management of Clinical Trials. It is an integrated, scalable system, tailored for compliance with GxP regulations, with product traceability, harmonisation of processes and allowing for reporting at Clinical Trial level.
The integral management of the Clinical Trial would be covered based on the Best Practices SAP and the use of the “classic modules” PS-Projects, PPDS-PP-MRP, QM-Inspection batches… but also including more specific and advanced functions such as HUM (Handling Unit Management), Series Numbers (Serialisation), features with Radio Frequency, IDocs-interfaces, etc.
An SAP project (PS) would bring together all the necessary features of a Clinical Trial: the medical information and the type of study, the phase in which it is located, IxRS provider, regulatory information, as well as the more purely logistic information such as number of hospitals, patients, when patients enter and leave the study, etc.
The following table summarises the SAP feature that would be used so as to cover the entire life cycle of the Clinical Trial.