Clinical trials: Temperature control influential in reducing wastage

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Temperature controlled logistics packaging is king for clinical trial supply practitioners on the hunt to minimize wastage in both time and money.

       
CTS

Respondents in the 2018 market report noted that temperature controlled logistics packaging is their spend priority to save time and money when supplying clinical studies with pharmaceutical drugs and biologics. 

Steve Jacobs, Chair, Global Clinical Supplies Group said: “I’m impressed that temperature controlled packaging is the highest. People are admitting they are losing a lot of components and drug product with regard to out of-spec results from distribution and temperature control.

“The other fascinating result here was regarding enabling real-time data visualization for planning and forecasting. It is encouraging that planning and forecasting efforts are really trying to decrease excess and the amount of over-packaged material that is destroyed at the end of the trial or beforehand because it reaches its expiry date.”

 “Supply chain visibility is becoming more of a requirement thanks to regulation.

“Ensuring patient enrollment data is correct and input in a timely manner ultimately links directly to the IRT technology piece. Those two go hand-in-hand as the IRT tells us how well the patient enrollment is going and the levels for each site. It also tracks inventory and allows us to maintain much better control and not produce as much overage, which is excellent.”

Read more: Clinical Trial Supply 2018 Report: The Quest To Shrink Wastage Levels

Temperature control

Temperature excursions can threaten a great loss of time and money for a drug supply chain.

Natural disasters, customs delays, handover mistakes and infrastructure complications often jeopardize the safety of medicines in transit, especially those that are temperature sensitive. It can take a matter of moments for a medicine to slip out of its permitted storage temperature.

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The packaging used to control the climate of a drug during transit needs to be validated and sized correctly to reduce freight costs where possible.

In designing the lane of choice the respondents of the survey noted the biggest deciding factors were the price of the product and the availability of the transportation of choice.

Temperature controlled packaging

Efficiency

When sites are under supplied, sponsors may be forced to halt enrolment or even freeze patient treatments. This could have a large influence on the outcomes of a trial.

Due to a range of factors (study design, patient enrolment, quantity of sites, site location) that can suddenly change the level of supplies needed for a trial to run, supply managers decide to reduce the risk of stock outs by supplying a surplus of medicine. 

This in many cases spills over to become overage – the investigational medicines  are wasted at the end of a clinical study or hit their expiry dates before consumption.

Some industry commentators maintain that some overage is needed to safeguard against the lack of predictability. But the industry’s heady overage rates need shrinking. Especially as public scrutiny on prices and spend of pharma companies heats up.

Cases have occurred where the actual budget of a clinical study greatly exceeded the expected amount – which could lead to the bankruptcy of a sponsor company

Bernard Jaucot, Director Strategic Solutions, Global Clinical Supplies PPD said: “Respondents are investing significantly in visibility and predictability. People are focusing on knowing exactly what is happening in the supply of their trials.

“This is so important, as this keeps us awake at night, and innovative technology has provided solutions in the last decade to [help us] sleep like a daisy.”

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