Temperature monitoring as a value-added service

The pharmaceutical industry is currently undergoing significant changes.

Companies are affected by increased competition from emerging markets,
pricing pressures, and pipeline challenges.
Providers in the industry, such as CRO’s, CMO’s and CDMO’s, need to
adapt or fear being left behind. As the Contract Manufacturing
Trend Report by Clarkston Consulting predicts, contract manufacturers
that differentiate their offerings and capabilities will have a much better
chance to retain their customers and grow their business within this
increasingly competitive marketplace.

One way to differentiate and enhance your offering to pharmaceutical sponsors is to offer temperature
monitoring as a value-added service. A cloud-based solution can help you and your sponsor achieve
leaner process flows and increased visibility across all clinical sites, which in turn results in improved
data availability and compliance as well as significant time and resource savings
both for you and your sponsor. There is even more to the story, below are some of the additional
benefits of a diversified and integrated temperature monitoring solution.

1. Efficient Excursion Management

Handling big volumes of temperature data and deviations can easily become a burden. Without the
right solution, you may find yourself hunting for the data you need through numerous pdf-files
that are manually emailed and thereafter stored somewhere in a local repository.
When providing temperature monitoring as a value-added service, it is important to
consider the solution’s capacity to efficiently handle temperature excursions. To avoid having to
manually keep track of temperature files, one should offer a cloud-based solution
where all of the shipment data is captured, automatically secured and instantly accessible in
the cloud.

“In other words, handling temperature excursions should not be a burden.”

With a modern solution, an automatic excursion email is sent to the assigned parties the moment
the monitor interacts with the system. The responsible person can then immediately initiate whatever
follow-up action is necessary. Also, the sponsor can be kept continuously updated on the mission status,
increasing the transparency and interaction throughout the process.
All of the data can later be accessed for further analysis and evaluation. For example if there is a
request from the sponsor to collect all outstanding temperature data from the different clinical sites, you
would already have all the data easily accessible in the cloud in a matter of seconds. When the data monitor
interacts with the system, an automatic excursion email is sent to the assigned parties and all data is
automatically stored and secure in the secure cloud data-base.

2. All Data is Automatically Linked to the Right Shipment

To ensure a smooth process flow, a cloud-based solution allows for each temperature record to be
automatically tied to a specific shipment. Through integration with SAP or other ERP systems, all
clinical study data as well as various types of meta-data, such as origin, destination, mode of transport,
packaging solution, or freight forwarder milestones, can be automatically associated with a shipment
and linked to the data logger. This type of automatic process can also be obtained by having 2D barcodes
printed on a packing list, unique for every shipment. All of these automated functionalities save time
and resources while reducing the risk for human mistakes.

3. Sponsor Saves Time and Effort through Customer Reports

Another value-added feature that you can recognize with a modern temperature monitoring solution
is extensive reporting capabilities. Depending on what information the sponsor wants to see, standardized
or customized reports can be compiled on a regular basis to enable the sponsor to analyze and assess the
performance of different parameters, such as routes, mode of transport, packaging solutions, or freight forwarders.
The prospect of manually going through numerous pdf-files on a regular basis is tedious and time consuming.
Therefore providing all necessary information through in-depth reports is typically a highly appreciated
feature by the sponsors.

Meeting Today’s Needs and Tomorrow’s Challenges

Although there are numerous different strategies to ponder in order to distinguish oneself from other
CMO, CRO’s and CDMO’s, there is one common denominator in order to be successful;
the ability to truly identify your customer’s current needs as well as
the challenges they are to face in the future. In order to succeed, you should be able to
meet these needs today and to tackle these challenges in the future. This can be done by
offering value-added services not yet offered by your competition.

Jenny Huzell
jenny.huzell@tss.se
+46-73-3650041