Management of clinical supplies in clinical trials has become a major hurdle in this new era of clinical research. With the complex challenges that clinical trials shoot in terms of the design or the study population or the subgroup categorization has put the supply chain managers in a critical pose.
IRT shall ease the work of the Supply Chain Managers by taking prior measures of a few main factors that hamper the management of the clinical supplies at sites. The new designs in the clinical study conduction involve the multi-centers that are in National and International locality.
A few of the main factors to be considered to take appropriate measures are:
- Maintaining an adequate quantity of supplies at site by the time the site is activated and the enrollment process is initiated.
- Taking appropriate measures to ship the supplies to multi-sites located nationally & internationally.
- Maintaining and shipping the supplies that are safe and not meeting the expiry in near future.
- Shipping the supplies by meeting the regulatory guidelines and standards.
IRT measures to overcome the Low Stock Supplies at Sites:
- As many of the studies are designed as multi-centric sites that cover various geo-locations, IRT shall capture the proper Leads days required to deliver the right ancillaries to right site at right time.
- To maintain adequate stock of supplies at sites by the time the enrollment process is initiated at particular sites, IRT shall initiate an advance shipment of required supplies to the site when the site is activated or the first subject is screened.
- As the duration of the study is long there is always a chance of shortfall of the supplies and they reach the expiry. To overcome this hurdle of the supplies reaching the Expiry leading to a shortfall of the supplies for the study, IRT shall plan in advance to notify the shortfall of the supplies and also regarding the expiry of the supplies which enables the supply chain managers/sponsor to plan their activities well in advance.
- As the charges of the shipment of supplies are going beyond the budget of the actual project, IRT shall take proper measures to meet the budget of the project by planning the shipment in such an organized manner where unnecessary shipments are avoided using its settings of check range, restock range, trigger value and resupply value.
- There is always a chance for regulatory to raise a query regarding the shipment of the IMP’s which shall delay the supplies restock at the site, IRT shall ship only those IMP’s from a particular lot’s for which the country submissions are provided as per the Regulatory bodies and which shall not delay the process of shipment.
- The site can reach to low stock at any level of the study that shall hamper the process of study continuation.To meet this clause IRT has come up with some new settings of auto orders. This will generate automatic shipments in advance once the site reaches the set level of the supplies at site that shall not allow the site to reach out of stock.
- As communication is the main bridge for any trial between the sponsors and stakeholders, considering that IRT has been designed with a separate functionality of Alerts & Notifications which shall communicate every user regarding the activities of the study and also alerts sponsors and Supply chain managers regarding the low stock levels at site, expiry of the supplies and shipment details.
Any challenge related to supplies in clinical trials can be faced with proper planning, assuming the risks & challenges in advance and, also maintaining continuous communication with the study team and sponsors.