The transformation of the old pharmaceutical supply chain into a data-driven, patient-centric value chain is upending the status quo in the Life Sciences industry. ATMPs, or advanced therapy medicinal products, open up new avenues for personalized treatments such as cell and gene therapies. With the introduction of ATMPs and new product and service offerings “beyond the pill,” the lines between pharmaceuticals and medical technology are blurring, and pharmaceutical companies must develop a fundamentally different end-to-end capability, focusing on truly patient-centric analysis and response across the entire value chain. Tomorrow’s commercial and clinical value chains will be leaner, faster, more flexible, self-orchestrated, and patient-centric, from the chemical to the patient, or vein-to-vein.

The ramifications for clinical trial procedures are substantial. The increasing number of new product launches has an impact on how pharmaceutical companies organise and conduct clinical trials: the number of studies is increasing while the number of trials is decreasing. Trial designs are becoming more complex as a result of companion diagnostics, combination products, and longer and more complex production and replenishment procedures. As the target population shrinks, the patient and site experience become more important, and patients are better informed, patient enrolment becomes more competitive. Finally, as the number of non-core countries increases, as do the challenges posed by rapidly changing global regulations, pharmaceutical companies are encountering an overall increase in the level of complexity in the end-to-end trial process.

What is the role of technology in this?

Technology is driving the evolution of the pharmaceutical industry. It is changing healthcare, medical practise, how pharmaceutical breakthroughs are delivered to patients, and how the pharmaceutical industry interacts with patients. Technology enhances the industry’s ability to innovate. As new technology and real-time data become available, we can expect a significant increase in the efficiency and effectiveness of the next wave of clinical trial supply. Remote clinical trials, as well as virtual clinical trials in the future, will soon pass from a futuristic trend to a real-world industry standard scenario. The next massive wave of innovation in the Life Sciences industry will begin with remote patient monitoring and real-time patient data access.

Transformational capabilities that is essential

A clinical trial supply management solution should include the following features in order to have a significant impact on future clinical supply processes:

• Faster planning cycles and new forms of clinical trial protocol set-ups can be accommodated.

• For an end-to-end information flow, harmonize master data and coordinate procedures.

• Standardize interfaces to allow for a quicker study start-up while also reducing the operational burden of the clinical supplies system landscape during trial execution.

• Be interoperable to enable for system flexibility and expansion, as well as minimal TCO maintenance and updates.

Simply by making study setup easier, good planning is essential for ensuring adequate supply provisioning during clinical research. CTSM-driven replenishment is based on real-time visibility into actual supply consumption, i.e., anticipating what is needed when and where it is needed, and then procuring, manufacturing, and shipping the required supplies without overproducing or risking supply shortages.

A range of data points must be gathered together in order to plan more accurately:

• Enrolment data, both planned and actual
• timetables for visits and dispensing,
• a studies or sub-studies’ overall lifespan state,

information on regulatory clearance for the launch of a study or the extension of a shelf life,

stock information in warehouses/depots that is up to date,

in-transit stock, in-transit stock, in-transit stock, in

orders that are currently being processed

and the patient kits’ real-time quality status, particularly in IoT sensor-monitored circumstances.

GM Sanjivani is a third-party manufacturer, bulk pharma exporter, and pharmaceutical contract manufacturer operating businesses in Venezuela, Saudi Arabia, Cambodia, Oman, Brazil, Lebanon, Chile, Peru, Cuba, and Fiji. Other services they provide are hospital supply, government supply, named patient supply, cold chain supply, and drop shipping.