Schreiner MediPharm extends its offering of smart packaging solutions by the new Smart Syringe Box. Thanks to integrated electronics, a wide variety of syringe packaging can now be digitized. The innovative solution enables automatic tracking of drug administration in clinical trials where precise therapy control is essential. Due to a special temperature monitoring feature, the Smart Syringe Box additionally provides benefits for temperature-sensitive biopharmaceuticals.

International clinical trials require maximum accuracy and efficient workflow but manual processes are often error-prone. Correct and regular administration of investigational drugs is essential but hard to monitor. Deviations from the dosing regimen can cause adulterated results and delays in time to market. A digital therapy monitoring solution such as the Smart Syringe Box provides crucial support in this case. Thanks to a cardboard layer with easy to open, perforated compartments, the removal of every single syringe can be precisely logged. The integrated electronics register relevant data such as removal time and the corresponding compartment in real time which are subsequently stored in the packaging and transmitted to a database via a smartphone app or Bluetooth.

A special benefit of the Smart Syringe Box is the option to integrate a temperature monitoring function. This is especially important for temperature-sensitive substances such as biopharmaceuticals as it enables tracking of the correct transportation and storage conditions. The adherence data generated not only support therapy tracking but also adjustments of individual therapy plans. The combination with specialized software enables central tracking, which facilitates the documentation and analysis
of the data.

Schreiner MediPharm adapts the integrated conductive lines precisely to the packaging design and the compartments to ensure reliable functionality and convenient handling. Scalable processes enable consistent automated production. The Smart Syringe Box offers numerous benefits for clinical trials: enhanced data quality, reduced failure rates due to non-adherence and optimized processes that reduce costs and shorten time to market of new drugs. At the same time, the need for manual documentation is eliminated, enabling higher flexibility and efficiency when conducting complex trials.

Digital Display Labels are a groundbreaking new approach for clinical trials. They enable flexible, digital marking of investigational drugs and have the potential to replace conventional labels in the future, eliminating the need for time-consuming re-labeling. This not only optimizes the supply chain but also accelerates the entire trial process and enhances efficiency in providing current information for patients and clinical personnel. Schreiner MediPharm has developed a new concept for this purpose.

Clinical trials demand utmost flexibility, speed, and precision but conventional labels with static information reach their limits in that regard. Changes in the patient group, the expiration date, or the protocol number as well as regulatory adjustments require complex re-labeling of the investigational drugs, which causes delays and high costs.

The Digital Display Label from Schreiner MediPharm is an electronic component with an e-label indicator. The solution is based on a modular, reusable plastic housing securely enclosing the display electronics. An adapter system enables the Digital Display Label to be connected to the respective packaging form. Thus, the label is suitable for flat applications like blister wallets or kit boxes and for round applications such as plastic bottles or vials. The latter can additionally be equipped with light protection or a blinding feature. The e-label content can be updated in real time so that patients and clinical personnel receive the information in a timely manner.

In addition to flexibility, the Digital Display Label scores with sustainability and reliability. Both the housing and the container adapter are reusable, which saves resources and avoids waste. The integrated electronics are protected against external influences and the adapter ensures a reliable connection between the Digital Display Label and the container or the packaging. Existing standard packaging can be used for integrating the Digital Display Label without any modifications.

Thanks to digital updating of the label information, delays due to manual re-labeling are eliminated, inventory levels are reduced, and the entire logistics process is optimized. At the same time, patient compliance increases and the risk of potential trial discontinuations due to label changes clearly decreases. Enhanced efficiency not only shortens time to market but also leads to significant cost savings for research-based pharmaceutical companies.

Ample information–quickly available: Schreiner MediPharm’s expert team for Clinical Trial Supplies (CTS) enables customized Booklet-Labels for a wide variety of uses. Thanks to a specialized process center, validated solutions are created according to the exacting quality standards of the pharmaceutical industry.

Clinical trials are often conducted on an international scale and call for utmost precision as well as efficient and safe processes. The investigational drugs must be reliably marked and provided with all the key information in several languages. Flexibility is crucial in order to enable short-term quantity adjustments in different countries.

The Solution: Booklet-Labels
Booklet-Labels are ideally suited for clinical trials because they have many pages and offer ample space for extensive text in several languages. Schreiner MediPharm’s CTS team develops customized Booklet-Labels reliably adhering to various container shapes and packaging, whether they are vials, syringes, blisters, pens/autoinjectors, tubes, boxes, or plastic containers.

Due to the use of very thin paper, the material structure of the Booklet-Labels is particularly flexible and suitable even for small containers with narrow radii. Value-adding functions such as hangers for infusion bottles, detachable documentation labels, RFID/NFC chips for interactive applications, or security features can be integrated. The combination with opaque films ensures reliable blinding. Special adhesives and materials additionally enable uses even at sub-zero temperatures. Increasingly, the sustainability of the solutions is moving into focus as well.

Efficient Production and Specialized Services
Schreiner MediPharm’s CTS team advises and supports customers individually across all trial stages, while achieving the fastest possible delivery times. Standardized workflows, materials, and testing processes ensure efficient and process-compliant production of the Booklet-Labels in a specialized process center. That’s where special services such as validated post printing of variable and randomized data are available as well. In addition, to optimize processes, Booklet-Labels can be pre-produced and placed into intermediate storage for variable post printing on short notice as needed. Regardless of the requirements, the CTS team will find a solution!

Further information about the wide range of solutions for clinical trials can be found on our website:
https://www.schreiner-group.com/en/products/clinical-trials

Less time–higher accuracy: Schreiner MediPharm has published a new video illustrating the benefits of smart blister packs in clinical trials compared to conventional methods. But what does the smart solution offer in comparison to traditional ones?

In the pharmaceutical industry, time-to-market is crucial. Clinical trials are complex, time-consuming, and cost-intensive and only as good as the data quality they generate. Conventional methods such as patient notes, assessments by healthcare professionals, or pillcounting are often inaccurate and may produce distorted outcomes. The new video from Schreiner MediPharm shows how those challenges can be overcome.

High Accuracy
With smart packaging from Schreiner MediPharm, digitally generated adherence data achieve nearly 98-percent accuracy. These innovative packaging solutions enable electronic collection, storage, and analysis of real-time data to ensure precision and reliability. At the same time, user friendliness remains at a high level—and taking pills as easy as usual. Schreiner MediPharm’s medication adherence monitoring solutions enhance therapy compliance and can help revolutionize the entire clinical trial landscape.

Learn about the benefits of smart blister packs in the video:

In a current clinical trial for a novel antibody drug conjugate (ADC), a specialty Light-Protect-Label from Schreiner MediPharm is used. It reliably protects not only the light-sensitive active ingredient but also enables an inspection of the vial content in the original color. In addition, it neutralizes the investigational drugs within the clinical trial.

Antibody drug conjugates are an important innovation in cancer therapy. Through targeted delivery of drugs into specific tumor cells they enable gentler and more effective treatment compared to conventional chemotherapies. This technology acts directly on the cancer cell, thus largely sparing healthy cells and minimizing side effects.

WuXi XDC is a leading contract research, development, and manufacturing organization (CRDMO) headquartered in China with a focus on the global ADC and bioconjugate market. To support a biotech company in a clinical trial for an ADC drug, WuXi XDC required a reliable label solution. Because the light-sensitive active ingredient is filled into vials as a lyophilized powder, effective protection against external influences was necessary. WuXi XDC found the most suitable solution through the cooperation with Schreiner MediPharm by implementing a Light-Protect-Label that perfectly met the specific customer requirements.

Schreiner MediPharm developed a solution with integrated UV and light protection that is suitable for transparent vials. The opaque label completely wraps around the container and offers optimal protection while a resealable inspection window enables an unadulterated view of the content. That is crucial for inspecting the condition and color of the reconstituted lyophilisate before it is administered and to thus ensure the efficacy of the medication. At the same time, the label from Schreiner MediPharm supports a dependable and safe conduct of the clinical trial by reliably blinding the investigational drugs. Hence WuXi XDC benefits from an efficient, multi-functional solution combining the protection of the light-sensitive active ingredient with reliable blinding during the clinical trial. This optimizes processes, accelerates trial workflow, and supports product and patient safety.

With Schreiner MediPharm’s Smart Blister Wallets, medication adherence in clinical trials can be monitored digitally and in real time. Supported by its partner Keystone, a leading US designer and manufacturer of pharmaceutical paperboard packaging, Schreiner MediPharm is now extending its product portfolio by a particularly child-resistant blister pack that can be customized and digitized by means of integrated electronics.

Key-Pak® is a flexible and versatile blister pack solution from Keystone Folding Box Company that is suitable for a variety of tablet forms, dosing regimens, and blisters. It has a special feature for opening the cavities ensuring a high level of child resistance as well as senior friendly use. Since its introduction in 2003, Key-Pak® has established itself as the clinical packaging standard and has been used in thousands of studies.

Schreiner MediPharm extends the child-resistant Key-Pak® Blister Wallet by an electronic function for digital medication monitoring. The blister wallet can be customized according to the respective clinical trial and its dosing regimen such as number of cavities, arrangement of the blisters, and various forms of tablets. Schreiner MediPharm’s development process ensures that the design of the integrated conductive lines is optimally adapted to the cavities. This guarantees that real-time data are automatically generated when the patient pushes a tablet out of the blister pack.

To track medication intake, for example, the time of removal, dose, and respective cavity are stored in the pack and transmitted by means of NFC or Bluetooth.

The Smart Blister Wallet based on Key-Pak® combines child resistance with high user friendliness for the patient and enables great flexibility for use in clinical trials. Digital tracking of patient compliance and the data gained optimizes processes, shortens trial periods, and accelerates approval processes for new drugs.

To ensure that clinical trial participants don’t know whether they are receiving the investigational drug or merely a placebo, the substances must be indistinguishable from each other. Schreiner MediPharm has developed a reliable blinding solution for vials used for clinical dosing: due to the use of colored film labels, the different liquids in the vials cannot be distinguished from each other—while the fill level can still be seen.

Before a new active pharmaceutical ingredient (API) can be approved for the market, extensive clinical trials are necessary to test its efficacy and safety. They involve comparative studies in which one group of the participants is treated with the new investigational drug, called verum, while a control group receives a placebo. It is crucial that the trial participants do not know which group is being treated with the investigational drug and which group with the placebo to ensure valid testing of the medication’s efficacy.

To ensure no one can tell which is the investigational drug and which is the placebo the two substances must not be visually distinguishable from each other. In the case of liquid APIs in transparent vials that is achieved by colored film labels from Schreiner MediPharm. The pharma expert developed them with WuXi STA. Among other things, the company offers clinical supply services for clinical trials and has been producing investigational drugs for clinical trials since 2008. To reliably blind, i.e., neutralize, its liquid investigational drugs, WuXi STA uses the film solution from Schreiner MediPharm.

The blinding solution consists of a self-adhesive label with semi-transparent yellow coloration that was developed precisely for the vials from WuXi STA. The label is transparent enough to see the fill level of the liquid in the vial. The solution from Schreiner MediPharm thus ensures efficient and flexible blinding of the investigational drugs and helps optimize the processes involved in a clinical trial—plus it complies with the requirements of clinical trial regulations.

Due to aging populations, the number of patients who are prescribed several drugs at the same time is increasing. In addition, the need for personal visits to doctor’s offices is declining as patients increasingly receive digital care and home deliveries of their medicines. However, the often complex medication plans do not always make it easy for patients to precisely adhere to them. To physicians, adherence monitoring poses an even greater challenge. The Smart Blister Card from Schreiner MediPharm can help resolve those issues.

In our aging societies, many people need to regularly take not just one but several medicines at different times of the day. That is the case in most industrial nations and the older people become the more drugs are added. Yet many patients and their families underestimate that polypharmacy, i.e. the permanent therapy involving several medications, may entail major risks. According to estimates, wrong parallel intake of different medicines causes up to 25,000 deaths in Germany alone. That risk increases especially when medication intake cannot be monitored by healthcare professionals—for instance when elderly patients take their medicines independently at home or receive in-home care by relatives.

In the case of polypharmaceutical applications, the medicines are frequently filled into standard blister packs according to the individual medication plan by hospital and large pharmacies. That eases the patients’ burden because the drugs are packaged in accordance with the dosage regimen. However, the attending physician or pharmacy have no way of tracking when the patient has taken the medications. That is possible with Schreiner MediPharm’s Smart Blister Card because it extends the standard blister pack by digital medication adherence monitoring of the patient. The conductive lines contained in the Smart Blister Card combined with an electronic unit enable automatic tracking as soon as the patient pushes tablets out of a cavity. That generates data in real time such as the time of removal, the dose, or the respective cavity. The data is stored in the Smart Blister Card and transmitted to a database via a smartphone app or a reader using NFC or Bluetooth technology.

At the same time, the application of the Smart Blister Card is a convenient and flexible procedure for physicians and pharmacists. After filling and sealing the blister pack, the Smart Blister Card is simply attached to the back of the pack without impairing the filling process in the polypharmaceutical application. The technology can be inconspicuously integrated into the packaging design, precisely adapted to the respective application, and is suitable for nearly all existing multi-dose and single-dose blister packs. Thanks to the transparent film with the conductive lines, the marking of each individual cavity concerning the medication it contains remains clearly visible. In addition, a temperature monitoring feature for sensitive active ingredients is an available option. Patients themselves do not need to do anything else than take their tablets as usual: With the Smart Blister Card, the cavities can be pushed through as easily as before. Smartphone apps provide patients with digital self-monitoring support of intake times and even enable a reminder function to comply with their medication plan. Thus, the risks of polypharmacy can be reduced and therapeutic success be enhanced.

Some years ago, incidental observations provided the basis for a new therapeutical approach in the field of cancer research: Following an infection with cowpox or rabies, cancer patients went into short-term remission. Subsequently, various types of viruses were tested against diverse tumors in clinical trials. These so-called “oncolytical viruses” are regarded as a novel kind of cancer therapy in which viruses infect and destroy the tumor cells. Yuan Song Biotechnology is a company engaged in viral therapy research. For its sensitive substance that is filled in vials, the Chinese pharmaceutical company needed a marking and documentation label. Schreiner MediPharm offered an ideal solution in the form of its Pharma-Comb IL Label.

One of the challenges during the label development for the unit dose vial was temperature stability because the sensitive active ingredients have to be stored and transported at minus 20 till minus 70 degrees Celsius and thawed prior to dispensing. The label has to reliably adhere to the vial at all times during this process. Healthcare professionals can check if the drug is flawless and the liquid is clear by means of a label-integrated transparent inspection window. As another key criterion, the label has to offer ample space for the most important information and include two detachable labels for documenting the medication administration in the patient and hospital files for the clinical trial.

The Pharma-Comb IL Label with detachable labels developed by Schreiner MediPharm convinced Yuan Song especially in terms of its multifunctionality and the temperature stability of the material and adhesive. It supports reliable and clear product marking from storage and transportation through to dispensing. The detachable labels have tabs for convenient handling and thus facilitate reliable documentation during the clinical trial.

With their specialized expertise, Schreiner MediPharm and AARDEX Group complement each other perfectly, and with their smart solution for digital medication adherence monitoring, are pursuing the goal of enhancing patient compliance especially in clinical trials. Non-adherence to the prescribed dosage regimen by patients participating in a trial may have severe consequences—such as inadequately documented efficacy of the medication or underestimated frequency of side effects. Stefan Wiedemann from Schreiner MediPharm and Bernard Vrijens from AARDEX Group talk about the capabilities of the digital Medication Adherence Monitoring solution and why it meets current and future trends.

How does the smart digital adherence monitoring solution from Schreiner MediPharm and AARDEX Group work?

Stefan Wiedemann (SW): Simply put, this is a smart form of pharmaceutical packaging combined with matching software. Blister packs for tablets are equipped with integrated electronics and sensor technology. Patients push their tablets out of the cavities as usual. The electronics are used to generate real-time data, such as time of removal, cavity, and dose, automatically store the data in the pack, and transmit it to a database via a smartphone app or reader. Specialized software subsequently serves to analyze the data.

How can digital adherence monitoring tools enhance patient compliance? Bernard Vrijens (BV): Digital Adherence Monitoring Tools can have a tangible impact on patient adherence to medications. But before we dive into the specifics of that, let’s look at the ramifications of poor adherence for the research industry. The stakes are high, both for drug developers and patients. When patients don’t take their medicine as prescribed, it can have life-altering or even life-threatening consequences.

Traditional, non-digital methods for monitoring adherence, such as pill count and self-report, do not consider such intricacies. They are subjective, open to bias, and merely provide a snapshot of medicine-taking behavior. Analogue methods also place an additional burden on patients and site staff, detracting from their utility. Digital adherence monitoring is different. It offers a holistic framework that can inform individualized intervention, even in therapeutic areas with notoriously high poor adherence rates, Oncology, and Psychiatry for example. What’s more, this type of approach is frictionless for the patients—all it asks of them is to take their medication.

What are possible drawbacks/challenges when it comes to digital adherence monitoring solutions and how can they be overcome?

BV: Historically, medication adherence has been the elephant in the room. And there’s a myth that drives this. Many know that poor adherence is prevalent in practice, but believe that it’s good in trials. We know that not to be true. Adherence is poor across the board. What’s more, some sponsors may not even realize that they have a non-adherence issue in their trials, and this is simply because what isn’t measured can’t be managed. This is a challenge—one that we can address quite easily in fact. Our approach to managing adherence is evidence-backed. Another challenge for sponsors is the change management process and the perceived complexity of implementing such solutions. This challenge isn’t exclusive to adherence management technology. It’s typical in industries that are very highly regulated.

SW: The complete solution for digital therapy control in clinical trials that we’ve developed can overcome exactly these challenges. It enables precise compliance with the requirements and dosage regimens for drug development according to the proposed clinical trial protocols of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Likewise, our digital tool can reveal structural deficits and collect important data about patient behavior. Such data can subsequently be used for marketing strategies.

What is AARDEX Group’s core competency and what is special about AARDEX MEMS® adherence software?

BV: What is measured can be managed, and on this front, AARDEX Group delivers. We’ve purposely expanded our ecosystem of partners to ensure that we have a device that can capture adherence behaviors—regardless of the route of administration. But collecting the data is only one side of the coin. The true value in MEMS AS® software is the statistical algorithms and behavioral analysis that underpin the solution. The inherent data processing capabilities negate the need for additional statistical analyses as the tool does it all automatically. Patient adherence analytics are conveniently presented in meaningful dashboard visualizations that can be interpreted at the patient, site, and study levels. Having access to readily available dashboards like these gives investigators the information they need to drive risk stratification and prevention. What’s more, the product is platform-agnostic and can be integrated with Interactive Response Technology (IRT), Electronic Data Capture (EDC), and Decentralized Clinical Trials (DCT).

What is the key benefit for AARDEX Group in cooperating with Schreiner MediPharm?

BV: Partnering with Schreiner MediPharm has allowed us to further reinforce our ecosystem with a solid partner for smart blisters. Together, with our common goal of enhancing the efficiency of drug development, by offering data generating packages and end-to-end solutions to manage medication adherence digitally, we will continue to thrive as the industry continues the shift to digital. What’s more, Schreiner MediPharm is a key player in this space, with solutions proven to deliver quality and high standards.

In your view, what are the key trends in Clinical Trial Management?

BV: For decades, the research industry has relied on the traditional trial model, where the majority of the trials conducted was built around sites, necessitating the need for in-person visits and monitoring. This was largely due to the fact that many sponsors were still using paper-based systems. However, when the pandemic hit, imposing restrictions on movement to reduce infections, the industry was pushed into a state of flux. While some sponsors had to halt trials, others embraced technology to ensure trial continuity. During this time, the industry truly realized the benefits of remote monitoring, not just for those conducting research but also for the participants. As a result, the use of remote monitoring has skyrocketed, prompting the FDA to create and publish draft guidance for the use of digital health technology in clinical investigations. I believe that the advent of this draft guidance will further cement Source Data Verification (SDV) for what it is, antiquated, and that the use of digital health technology and remote monitoring technology trials will rise rapidly.

How can digital adherence monitoring tools enhance patient compliance and how can they meet current and future trends?

BV: The utilization of Digital Health Technologies (DHT) is rising rapidly in clinical research. When talking about the decentralization of trials, David Burrow, the director of the FDA Office of Scientific Investigations, was quoted stating that they were “here to stay”. This, combined with the recent FDA draft DHT guidance, will serve as catalysts for the industry’s ongoing shift to digital. However, with fewer or no site visits on the table, this model could present an issue for sponsors that rely on traditional methods of measuring adherence, blood sampling, etc., Digital Adherence Monitoring bridges the gap by continuously monitoring patient medication-taking behaviors remotely.

What are the tangible benefits of the partnership between Schreiner MediPharm and AARDEX Group for pharmaceutical manufacturers?

SW: In our cooperation, we combine Schreiner MediPharm’s in-depth expertise in printing and packaging technology with AARDEX Group’s IT intelligence. We provide pharmaceutical manufacturers or CMOs with a wallet including printed electronics and all they have to do is integrate the blister. Their production processes remain unchanged. The flexibility we’re able to offer them is a major benefit. Due to roll-to-roll processing, our technology can be scaled from small volumes all the way to mass manufacturing. As a result, pharmaceutical manufacturers can fully exploit the potential of the digital adherence monitoring solution in clinical trials as well as use it in the commercial context.