DRUG DELIVERY DEVICES
remote monitoring by healthcare professionals. Such devices can be leveraged in decentralised clinical trials and connected via an app or cloud platform to the contract research organisation (CRO) or sponsor to allow remote monitoring of patient parameters during the remote trial. Injectable drug delivery devices fit the same model. Patients are familiar with self-injectors, whether from personal experience or through friends or family who regularly self-inject, for example to manage diabetes and auto-immune diseases. Adding digital technologies elevates their value during decentralised clinical studies.
Connected injectable drug delivery Compliance and data integrity are cornerstones of decentralised remote/hybrid clinical trials. With trials of self-injectable drugs, compliance with administration regimens – times and dosages – is challenging. Disparity between nominal doses and administered doses is common, and patients don’t always remember to self-inject at the right time. Injectable drug delivery devices that are equipped with digital technologies and wireless connectivity can reduce the risks of non- compliance or incorrect dosing. Trial operators (the CRO/pharmaceutical company/sponsor) can monitor injection activity, confirm compliance with the injection schedule defined in the study protocols, and gather data remotely. Connected injectable drug delivery devices
improve the entire communication process with all stakeholders and simplify the process of gathering and analysing data, with a level of data integrity and security that is not possible with manual self-reporting by the patient. They also help increase patient engagement. Patients can get timely feedback, which may include viewing their own trial data or study statistics, receiving updates about the current trial or upcoming studies, and getting reminders and other notifications that make participation easier.
SYNNECT®: smart drug delivery for trials DALI’s SYNNECT connected digital injection solution provides an exceptionally versatile and high-performance device for use in decentralised remote/hybrid clinical trials of injectable drugs. SYNNECT utilises sensing and connectivity technologies to accurately measure the injected drug’s data (administered volume, rate, and
58 | Outsourcing in Clinical Trials Handbook
pattern) and transmit it in real time through a dedicated mobile app to a secure cloud for analysis and sharing. SYNNECT can validate drug and patient identification, enabling an automated process that decreases the chances for mistakes that could invalidate study results. It also tracks drug storage conditions, including while the drug is at the patient’s home, simplifying the trial supply chain logistics. With its remote measuring technologies (RMT) and remote patient monitoring (RPM) capabilities, SYNNECT enables all stakeholders – pharmaceutical companies, sponsors and CROs – to stay updated and in control. With access to updated patient and injection data, the CRO can take proactive action if a patient fails to adhere to the prescribed treatment protocol, and potentially prevent patients from being excluded from the trial. Using SYNNECT in combination with a mobile app to send push notifications, such as injection reminders and alerts, can improve patient engagement, further helping with patient retention. SYNNECT transforms a basic syringe into a connected injection device that can monitor the injection process, offer injection administration alerts and integrate with trial data management platforms. Compatible with a wide variety of standard, prefilled and safety syringes, it replaces only the plunger rod part of the syringe, and does not require any changes to the drug’s primary packaging as it does not come into contact with the drug.
Combining the SYNNECT with a SAN-L
provides a full solution for decentralised trials, solving the challenges of patient safety, compliance and ease of use.
Conclusion
Digital health, remote monitoring, and connected devices are all vital elements for decentralised, remote and hybrid clinical trials. CROs, pharmas and sponsors have much to gain by integrating digital connected injectable drug delivery devices in clinical trials. The advanced features and capabilities of devices such as DALI’s full injectable drug delivery solution, which combines the SYNNECT smart injection solution and the SAN-L passive safety needle, make it easier to recruit and retain patients, while ensuring patient safety, compliance with trial protocols, ease of use, and data integrity.
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