CASE STUDY WEIGHING THE OPTIONS IN ADDRESSING A SUPPLY ISSUEMid-trial decisions to address unexpected issues—such as a product shortage—deserve to be made with all the facts. Often, those facts are hard to come by and require visibility to the entire supply chain. That was the case for one sponsor conducting a complex Phase III trial across a number of countries. Almac Clinical Technologies and Almac Clinical Services business units teamed up to provide a complete risk assessment and cost analysis of various solutions, making the most cost-effective choice obvious.

COMPREHENSIVE ANALYSIS UNCOVERS ALL THE FACTS

AN URGENT NEED FOR A RISK REDUCTION WELL INTO THE PHASE III TRIAL SUPPLIES OF THE EXPENSIVE COMPARATOR PRODUCT BEGAN TO DWINDLE, CREATING AN ISSUE FOR INVESTIGATIONAL SITES

THE SITUATION: SUPPLY SHORTAGE RENDERS FULL DRUG ASSIGNMENTS IMPRACTICAL

A leading global pharmaceutical company was conducting an open-label, Phase III trial with a complex protocol that allowed investigators flexibility in how they titrated each patient’s dosing over an extended visit schedule. Drug assignments made via Almac’s Interactive Response Technology (IRT) platform, IXRS® were, in accordance with the protocol, dispensing drug amounts that the investigator could then choose to administer all at once or over multiple visits if that best suited the patient’s condition.

Well into the trial, however, supplies of the expensive comparator product began to dwindle, creating issues for investigational sites. When stock at a site was low, investigators had two choices: turn patients away or dip into stock that was on hand and which had been assigned to another patient, although not yet administered.

In the short-term, the sponsor was allowing sites to track drug assignments manually, outside of the IRT system, in order to dispense available stock to accommodate the greatest number of patients. This was a less than ideal solution that was not only onerous for sites, but had the potential to introduce human error into an otherwise automated and validated system. The sponsor requested feedback from Almac on a high-risk solution—one that would need to be implemented urgently.

ALMAC EXPERTS COME TOGETHER AS ONE ALMAC CLINICAL SERVICES AND CLINICAL TECHNOLOGY BUSINESS UNITS JOINED FORCES TO INCREASE THE SOLUTION OPTIONS FOR THE SPONSOR

THE SOLUTION: COST / BENEFIT ANALYSIS SUPPORTS PARTIAL DRUG DISPENSATION

Because the sponsor was also relying on the Almac Clinical Services business unit to package and distribute the product, the Almac Clinical Technologies unit was able to confer with colleagues in their sister division as they studied the situation. Together, the group was able to come up with a range of possible solutions and then perform a shared risk assessment / cost analysis on each. They weighed:

• The supply and tracking challenges associated with allowing the existing strategy of manual assignment outside of IXRS to continue. These included a possible impact on data quality and time spent communicating assignments made manually.

• The cost and associated impact / risk of reprogramming IXRS to allow for partial drug dispensation, particularly considering timelines and regression testing required for this complex design

• The cost of procuring more medication to allow for sufficient overage based on usage patterns to date

• The distribution challenges involved in shipping smaller quantities of the product more frequently, including the administrative burden for sites, substantial shipping costs, and risk of increasing numbers of temperature excursions

• The risk to the study analysis of limited medication availability

• The impact of amending the protocol to require assignment at weekly intervals, including the training burden on sites

Based on this thorough analysis, the sponsor recognised that amending the drug dispensation logic in IXRS to allow for partial dispensation was actually the most cost-effective solution, however there were risks which the team would need to mitigate. With that direction, Almac set about making the system changes as quickly as possible.

www.almacgroup.com

ADVANTAGES IN HAVING VISIBILITY OF THE ENTIRE SUPPLY CHAIN

THE RESULT: A CLEAR-CUT DECISION WITH NO HIDDEN COSTS

Almac amended the dispensation “rules” within IXRS so that drug supplies can be dispensed to optimise short supplies, without having to maintain manual study records. In choosing this option, the sponsor had the benefit of Almac’s thorough analysis and was able to understand the risks and costs associated with each solution. There were no unexplored options and no hidden costs that could crop up down the road.

This complete understanding of the alternatives was made possible because Almac’s combined technology and services business units had visibility of the entire supply chain and were in possession of all of the facts. The sponsor did not have to make a system decision without knowing what it would do to the distribution logistics, and vice versa. The system and the supply chain are aligned and supporting optimal allocation of the product.

GET IN TOUCH

UKAlmac Group(Global Headquarters)Seagoe Industrial EstateCraigavonBT63 5UAUnited Kingdom clinicaltech@almacgroup.com+44 28 3835 2121

USAlmac Group(US Headquarters)25 Fretz RoadSouderton, PA 18964United States of America

clinicaltech@almacgroup.com+1 215 660 8500

ASIA PACIFICAlmac Pharmaceutical Services Pte. Ltd.(Asia Pacific Headquarters)9 Changi South Street 3#01-01Singapore 486361

clinicaltech@almacgroup.com+65 6309 0720

AM1172

All our clients have unique needs. That’s why we develop unique solutions. This is the

Schedule a demo of IXRS 3® today!

Email us atclinicaltech@almacgroup.com