Clinical supply management is facing a number of challenges in a rapidly changing environment which necessitates constant adjustments. Innovations enable the clinical supply chain to brace for upcoming challenges.
In pharmaceutical and clinical development, the customer and the sponsor have different views on innovation and improvement. However, there are also aspects which are of utmost importance for both parties, such as patient safety, study adherence, compliance, and others (Fig.1).
Supply chains are increasingly demanding improvements in this field. The development of innovative kit designs and supportive tools are the only examples of how new trends and technologies in clinical supply management may contribute to improvements in pharmaceutical and clinical development.
Figure 1: Key Drivers for Improvement and Innovation in Pharmaceutical and Clinical Development
The Bayer Matrix
Advances in the science and technology of global supply chain management offer a huge number of opportunities for innovation and improvement. Innovative ideas target very different challenges within the clinical supply chain in various manners. Therefore, after the initial phase of unprejudiced gathering of innovative ideas, the scope of what matters and what may benefit for a specific company and their portfolio has to be defined.
At Bayer, a matrix was developed that objectively evaluates trends and technologies in clinical supply management. Assessment criteria were defined to filter the innovative ideas according to the following topics:
i. Can the innovative idea contribute to or provide solutions for patient safety and adherence to study treatment?
ii. Can the innovative idea underpin reliability and compliance of the supply chain?
iii. Can the innovative idea enhance the attractiveness of a clinical study to patients and/or principal investigators?
iv. Can the innovative idea result in more economical use of resources?
Additionally, the impact on or value for the clinical supply chain, as well as effort and investment for implementation of an innovative idea, has to be considered in this evaluation. In order to minimize subjective preferences as much as possible, categories low, medium and high for both efforts/investments and impact/value has been set (Fig. 2 and Fig. 3.).
Figure 2: Impact/Value – Examples: Definition of Categories Low, Medium, and High
Impact and Value on the Clinical Supply Chain
By nature, not each and every innovative idea may touch all of the mentioned examples for impact or value on the clinical supply chain the same way. Furthermore, there may be additional points of more importance in evaluating impact/value depending on the pharmaceutical company and/or their portfolio.
The same is applicable for the categorization of efforts and investments. For instance, the capacity needed for implementing and maintaining an innovative process may be acceptable for one (big) pharmaceutical company, but may be too high for another (small) one. The matrix displayed may serve only as a guide. The definitive categorization of efforts and investments, and the impact of innovative ideas into low, medium or high depend much on a company’s strategic, budgetary and capacitive prospects.
Figure 3: Effort/Investments – Examples: Definition of Categories Low, Medium, and High
Leveraging QR Codes
Implementing a QR code to provide additional information was selected from the multitude of innovative ideas to be presented as a case study where the above mentioned matrix was applied to. Overall, using a QR code may increase patient safety and adherence to study treatment, may enhance the attractiveness of taking part on a study for and may also result in better economical use of resources, e.g. by avoiding premature discontinuation of treatment and hence reduction of waste. Value as well as the effort and investment for this measure were classified as Medium.
The current focus at Bayer is to provide additional information for site personnel and patients, whereas (partial) replacement of paper labels by electronic media is currently not a priority. One reason is that the acceptance by Regulatory Authorities for such behavior is currently unclear and may be accepted perhaps only in individual cases. On the other hand, a QR code read out using a tablet or mobile needs a stable internet, which is still not available worldwide. In large global studies, required regulatory information could get lost if only coded with a QR code in countries or at sites were no sufficient internet capacity is available.
A pediatric study in which the patient’s caregiver has to prepare the study medication at home was selected to provide additionally to the paper based handling instruction a QR code which encodes a cartoon video showing the preparation and application of the drug. The spoken explanation is given in the respective local language from the countries in which the study is running.
A Fast and Easy Way to Improve the Clinical Supply Chain
The QR code is a separate label additionally placed on the drug kit as well as on the paper-based handling instruction. It can be read using any QR code reader downloaded from the internet. The QR code can be read by the system software Android or by iOS. The videos are stored in a secure IT platform with specific links to the different language versions of the video.
After scanning the QR code, a link opens for selection of the local language. The link opens the chosen language version of the video. By pushing the triangle on the display, the video starts (Fig. 4). The total length of the video is two minutes. All steps needed for preparation and storage of the prepared drinking solution, including use of provided ancillaries (e.g. dispensing syringes), are explained in short sentences that are easy to understand. The feedback from the patient’s caregivers about their satisfaction with the QR code implementation will be collected by questionnaire at the end of the study.
Figure 4: Starting the handling instruction video by read-out of the QR code using an electronic device
In summary, the QR code is a fast and easy way to improve the clinical supply chain. Meanwhile, using a QR code is on-the shelf technology used in many different industries. QR codes convey additional information in many formats that is accepted by Regulatory Authorities. Finally, QR codes may foster patient safety and adherence to study protocols, especially with “Not-Ready-to-Use” medications that may become more commonplace with new treatment regimens of severe diseases in the future.
Innovation neither becomes reality without support from the line management nor is the result of efforts by only one person. It is important to acknowledge the people at Bayer for the great support given and our partner who made a significant contribution to the success of the presented case study.
Bayer AG: Dr. Olaf Queckenberg, Dr. Thomas Fahrig, Dr. Saskia Wichmann, Dr. Torsten Holletz
Fisher Clinical Services: Stefanie Leitenberger