Clinical Trial Supplies Management

Measures to Overcome Low Stock Supplies in Clinical Trials Using IRT

Mon, 28 Sep 2020 11:35:18 +0000

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.

Tags: Clinical Trial Supplies Management, Clinical Trials

Main Factors that Unify IRT in Clinical Supplies

Thu, 24 Sep 2020 12:02:31 +0000

IRT has created its footprint in the field of clinical research and has evolved drastically in such a way that it has bought a major difference in perspective of clinical trials over the decades. It faceted itself into the streams from only randomizing the subject and assigning them to a treatment group to managing the overall supplies required throughout the study through supply management.

Multiple factors fall in line to manage the supplies throughout the study, where few of them are the number of subjects expected to be enrolled in each site, the number of days the shipments reached the site physically, etc. These factors help the system to develop algorithms that will monitor the supplies existing at site, supplies required at site within a month, and many more. These algorithms are more essential for an IRT system to function in such a way that there is no low stock of supplies at site. Few main facets that enable the IRT to function effectively are discussed below.

Initial ordering of Supplies:
This is one of the main facets that enable the function of supply management. This facet functions through various factors like site activation, subject screening settings. The supplies shall be distributed to sites based on the predefined parameter settings given to the system.
To perform the activities of a subject, there requires a sufficient quantity of supplies. Those requirements are fulfilled by the initial shipment settings. Based on a few factors initial shipment to sites shall be raised either when the site is activated or when the first subject is screened at site, which shall prepare the site to perform the further activities of subjects screened flawlessly.
Auto Ordering of Supplies:
This is one of the most important facets for managing the stock of supplies at sites. The auto orders shall be raised as on when required to meet the predictive needs and non-predictive needs of the supplies at site. These settings shall be site-specific and designed based on the parameters like recruitment rate of the site, trigger value, resupply value, check range, and the restock range.
The predictive needs of the site are fulfilled through predictive settings given to the system.The System shall check the values given and raise the shipment accordingly with the required quantity of kits with kit types from the lots.
The non-predictive needs of the site are fulfilled with the buffer settings given to the system. System shall raise the shipment according to the values provided.This way the IRT functions effectively to maintain the supplies at each site.
Safety Settings:
These settings play a vital role at supply level and site level. These settings are designed in such a way that the expired supplies are not reaching the subject in any way. Maintaining the expired supplies and shipping them is a waste of resource, time, and cost too.
Each shipment is very important and it shall be planned in such a way that the budget of the project does not affect in any way. These safety settings and auto-order settings shall add value to the tool in customizing the shipments as per the requirements and unnecessary shipments are not raised.
The shipment or dispensing of the expired supplies is halted with parameters like DND (Do Not Dispense), DNS (Do Not Ship) & DNC (Do Not Consider) which are core terms in IRT.
Site Activation:
This one of the core steps to be performed, as all sites, shall not be activated at a time. As per the regulatory and the success of SIV a site shall be activated. This action requires authentication as there shall be an initiation of supply to the site once it is activated.Once the site is activated, the site shall be enabled for the screening activities, randomization activities, and supply-related activities. The Site needs to be configured with all the data as per the protocol before activating.Once the site is activated, the system shall raise the initial shipment as per the settings provided, the request of the shipment would include the number of kits from the defined lot, expiry date, site details so that the supply manager shall record all the data and ship the required kits physically. Supply activities of the site include the acknowledgment of shipment once received at site.
Tracking of the supplies:
Tracking of supplies is one of the main focus points of IRT. Even though it does not track the live movement of the supplies, there is a passive way of tracking which shall deal with the change in the status of the supplies as when required.
The System shall have a different status for the orders and the kits. These statuses shall be permission-based and only the desired personal shall change the status so that it is recorded and tracked in the system.
Multiple depots and sites shipments:
The distribution of supplies in a clinical trial is not only defined for a single site or depot, it involves many sites and depots. It can be both depot to depots, depot to sites. Each site shall be assigned to a depot for supply-related activities. The supplies for that particular site shall be maintained by that depot which shall be easy for tracking and resolving any issues related to supplies. The depots shall be maintained with sufficient quantity of IP’s throughout the study to meet the requirements at the site. A line of authorization is built in while shipping the supplies to sites as not all sites require the supplies as generated by the settings provided for the system. This line authorization shall check and cross verify the requirements with site and approve the shipment. This level shall not allow the overflow of supplies to sites when there is no such requirement.
There shall always exist the physical shipment of supplies from the sites with overstock to the site having low stock. This physical shipment shall be tracked in the system with a functionality called ‘Return to Depot’ where the sites with overstock shall return the supplies to Depot and the shipment shall be generated from the site with low stock. This feature helps to manage the supplies without any further demand in the production.
An Eagle Eye – Audit Trail:
It is mandatory for a trial personal to know each and every aspect of the study regarding the activities of site, depot, kit, users. This will always help the administration team to view the status of the study and monitor the pros and cons during the study conduction.
The audit trail is designed in such a way that an administration team can filter and know the activities by user wise, site-wise, depot wise, and the status and history of kits as well.
Data Visualization through Dashboards and Reports:
There shall be many factors to be focused on throughout the conduction of the study. These parameters shall be monitored easily when their status is displayed on the dashboard and the data is projected in the form of reports.
The pending visits of a subject can enable the administrator to plan the resource and check the supplies at site. The summary of orders on dashboard also helps the trial team to track the supplies.
The reports should be developed in such a way that it gives the complete overview of the study in terms of the sites, depots, kits, visits, etc. It should be easily accessible and user-readable.
The events and alerts shall be shared with the desired team as on when required in the form of notifications and are one of the other best ways to inform the status of the study being conducted.
IRT is recognized as the realistic data provider so that it can be integrated with other tools like EDC and CTMS as a source data provider. The evolution of IRT is not defined to a certain point, as the designs of the studies increase the evolution and the facets of IRT also increases.

Tags: Clinical Trial Supplies Management, Clinical Trials

Importance of DSCM in Managing Clinical Supplies during COVID

Fri, 10 Jul 2020 05:04:29 +0000

It’s a known fact that the Pandemic Effect of Covid-19 apart from creating the hurdles in Clinical Research has also fetched a possibility to many of the new innovations. Supply Chain Management is one of the majorly effected streams due to pandemic which lead to low stock of the API to pursue the Manufacturing of the IMP for clinical trials.

It’s time to invest additional efforts on strategy development for managing the clinical supply activities in more efficient way. The scope of the supply chain management can be made efficient by creating solutions to the current and anticipated challenges.

As industry is also focused more on ‘Direct-to-Patient’ model, Drug Supply Chain Management has a primary role in this.

Few areas of focus for DSCM include:

Quality: Quality is of course one of the first and foremost key point that needs to be focused. In DtP the concept basically relies on providing the Right Quantity of Supplies to a Right Subject at the Right Time in Right Condition. This shall enable the progress of the study more effectively. Even though it’s not easy to perform these type of tasks during a pandemic, but can be handled efficiently using newer technologies.
Cost Effectiveness: The cost and the liability of the labor, logistics, and energy shall increase globally due to the current constraints. Even though the budget of the running project is approved upfront,to run the operations effectively with quality, within the set budget, proper cost control plans should be executed through constant monitoring of the logistics and wastage
Risk Management: To meet the needs of the subject according to the protocolcriteria proper Risk Management Plans shall be implemented. Whereas for DtP in clinical research, shipping of supplies direct to subjects involves several risks right from shipping to storage to compliance and accountability. Each of these steps need to assessed with proper risk minimization or mitigations plans
Qualified Resources: DSCM need to focus more on the qualification and training of the staff as DtP is not a simple logistic task. Manpower should be qualified, trained and accountable. They shall be trained and educated more on their responsibilities and action plans to be performed in DtP scenario. While supplying Direct to Patients, teams should develop interaction with the subjects in confirming their demographics, addresses and maintain a good relationship. Should also be trained to collect any return samples left at the subject in order to meet the accountability of the supplies.
Delay in Delivery: In clinical research the delay in the Treatment Assignment leads to several consequences. Teams should be more cautious in planning the activities related to supplies by anticipating the unforeseen risks that shall lead to delay in supply delivery.
Adaptation to Needs: It is not easy to adapt to changes but sometimes we cannot abandon the clinical or patent requirements if we need to stand in the race of the research. It is now mandatory to take up the challenge of delivering the supplies direct to patients to withstand the need of the hour.

DSCM should use an effective IRT system that can handle most of these activities to help save time. IRT can help in managing the risks by leveraging automation, supply options, timely alerts and maintain regulatory compliance

Tags: Clinical Trial Supplies Management, Clinical Trials

Ensuring Drug Accountability Compliance with IRT

Mon, 22 Jun 2020 05:20:10 +0000

Drug Accountability of the Investigation Medication begins from the selection of location for its storage. Issues with drug accountability are major and the majority of warning letters from regulators are a result of this. Major delays are faced by sites for non-conformity and it often leads to non-acceptance of trial data. Drug accountability is of utmost importance and it is the clinical investigator who remains responsible for the entire process taking place at the clinical site. If the supplies are controlled substances then more attention shall be needed from the Investigator in terms of its storage and disposition. IRT systems allow in streamlining such processes by keeping a single source of data and hence the process of Drug Accountability tracking becomes easier.

Paper-based Drug Accountability Challenges

It is the complexity surrounding the paper-based systems that makes them more prone to errors. Drug accountability shall be maintained at sponsor level and site level. The Investigational medication documented as shipped should reconcile with the documentation of used and unused. The Drug Accountability at site begins once an investigational drug reaches the site. Records need to be maintained and staffs need to confirm that the contents that have been shipped match its previous record. The authorized person needs to put his signature with date after thorough verification. Once these have been completed, the investigational drug needs to be stored securely maintaining the standards specified in the protocol. Entire details need to be updated in the drug accountability log and with the commencement of trials; drug dispensing records are to be updated in writing in multiple documents. Site shall maintain all the data of the drugs right from drug dispensing to final disposition. Paper-based drug accountability never ends with the end of study, discrepancies in accountability logs need to be resolved, and its copies are to be returned with the original shipment records. The sponsor should receive the reconciled log along with the returned investigational drugs. Any discrepancy in drug accountability not only violates the regulations but also points the integrity of the study and public health.

Mitigating Challenges through IRT

Utilizing electronic medium for data collection and tracking helps in mitigating the challenges associated with data accountability. When data associated with a trial gets centralized, then the visibility gets doubly enhanced and a single accountable system improves the process of reporting. This entire method eases regulatory compliance achievement process and accountability audit issues get resolved immediately. As the use of the IRT system increases the pace, end-of-study documents are prepared in no time using the single system as the source.

mIRT has a special feature to track Drug Accountability where the reconciliation of the supplies that are used, lost, damaged and returned shall be captured which enables the system to calculate the compliance of the drug automatically.

Future of Drug Accountability

With the current advancements, as the world is moving ahead and accepting technology, there is an increased level of visibility in the supply chain for both the regulators and sponsors.

Tags: Clinical Trial Supplies Management, Clinical Trials

Data Integrity in Clinical Trial through IRT

Thu, 28 May 2020 10:50:48 +0000

What is Data Integrity?

Integrity of data is ensured only when initial remains valid throughout the product life cycle. If the accuracy comes under question at any point in time then data integrity would collapse. ALCOA system is the best method of defining and measuring data integrity. It can be broadly expressed as:

Technology Driven Automation

Attributable: A single person to be held responsible and accountable from the beginning to the completion of a particular task.

Legible: The data gathered should be clear and simplified so that it is easy to read and conceive and can be preserved for future usages.

Contemporaneous: The data created and the activity conducted need to be running simultaneously i.e., in real-time.

Original: The data should be authentic and its validity to be maintained throughout the product life cycle.

Accurate: Resemblance of the task and data is necessary to prove accuracy.

IRT’s Impact on Data Integrity

a.Managing of Blinds

Interactive Response Technology (IRT) helps in systematically maintaining data blind. All the data starting with assignment of treatment and continuing towards ultimate data analysis can be easily viewed in the audit trail timeline. Unblinding of data is generally the outcome when there is no or a poor IRT system in effect. Finally, it is the responsibility of all the stakeholders to pay special attention while the blind is being enforced so that it can be maintained all through.

b.Streamlining Audit Trail

Data of Audit Trail are extremely significant as later inspections related to pharmacokinetic studies; randomization or a double-blind could be benefitted from it. The final data can be reviewed by comparing the source data with the end data. It is enough to reveal whether the subjects received opposite treatment meaning active drugs and not a placebo or they received mixed treatment where they were given both active drug and placebo or the drugs were given under wrong dietary conditions like dosage to be given in fasting were given after feeding and vice versa. IRT system makes it easier to trace all these details through the audit trail so that issues can be handled on time rather than discovering them during an inspection.

It is data integrity that the entire industry is concerned about and IRT systems will ensure it only if it is properly verified. So, for vendors it is of utmost importance to verify the IRT not only for vendor qualification but also during the implementation of protocol change or any such other changes. This will ensure that the data that you retrieve is completely integrated.

Tags: Clinical Trial Supplies Management, Clinical Trials