Temperature monitoring for clinical trials

Why temperature monitoring plays an important role in clinical trials

Clinical trials play a vital role in developing life-saving and life-enhancing therapies in all areas of medicine. Across the country, NHS Research Teams are involved in a mixed portfolio of clinical trials. These include both initiatives with commercial sponsors from private sector organisations such as pharmaceutical companies, and non-commercial trials, funded by public bodies such as the NHS, universities and charities.

Trials are not always Clinical Trials of Investigational Medicinal Products (CTIMPs); they may also be IPs (Investigational Products) focused around trialling equipment and technology, or even involve a combination of the two, such as new imaging techniques and medications.

Strict monitoring protocols

All are subject to strict monitoring regimes. CTIMPs conducted in both NHS and dedicated clinical research facilities are authorised in the UK by the MHRA (Medicines and Healthcare products Regulatory Agency). Good Clinical Practice (GCP) underpins all CTIMPs with human participants; the primary concern is always to maintain patient safety at all times.

Temperature monitoring for Good Clinical Practice

GCP focuses on two significant aspects; protection of participants from harm, and collection of quality data. Against this background, the ability to closely monitor the drugs and medications involved and to be able to demonstrate that they have been stored and maintained at the correct temperature levels can present a real operational challenge.

For each individual trial, it is the daily responsibility of a member of the hands-on research team to manage and document processes involving temperature monitoring, medicine storage, administration of medicines and data collection. Data may be requested by Principal Investigators (PIs) and Chief Investigators (CIs) at any time; having this information collated and easily available at the touch of a button simplifies and speeds up the response process.

The challenges for accurate temperature monitoring

Temperature control reporting for both ambient and chilled storage facilities can be a difficult and time-consuming task, particularly for multicentre trials, where linked research is taking place in a range of geographical locations to facilitate higher numbers of participants. Here, demonstrating effective temperature control at all times using manual processes can be almost impossible in terms of accurately ascertaining and reporting on the correct storage and efficacy of medicinal products.

Why choose an automated temperature monitoring system?

Save time and money, secure accuracy

An effective automated temperature monitoring system provides the perfect combination of accuracy, visibility of and access to the data required in support of trials. Collating and managing this volume of data using manual or datalogger systems would require significant levels of valuable research time as well as incorporating the potential for human error when collecting and transcribing data.

Keep the medications safe

A good, automated temperature monitoring system such as RemoteM provides evidence that the medications have been kept at prime temperatures to ensure their efficacy. It will also include an efficient alert system to advise 24/7 if a particular fridge, freezer or ambient area is out of temperature range – particularly important for some research facilities which may not be manned round the clock. The therapies involved in clinical trials are often extremely expensive and closely targeted, such as biologic treatments, and it is vital to control temperature to maintain the efficacy of the medications alongside eliminating the potential for wastage.

Ensure compliance

An automated temperature monitoring system is also advantageous for MHRA and CQC (Care Quality Commission) inspections, carried out routinely to monitor sponsor competency at clinical trials. For multicentre trials, a system such as RemoteM, which can be accessed from any device in any geographical location, makes it quick and easy for Chief Investigators to check and verify information. Quick and easy collation of data provided by automated systems also makes a valuable contribution to speed and professionalism.

Assist with infection control

Governing bodies like the MHRA and CQC also stipulate regular cleaning of fridges for infection control. The RemoteM system, with its small, flush standalone nodes, is a good solution requiring no probes, no tangle of wires and no pots of liquid, proving easy, quick and safe to clean and disinfect.

Mobile options

RemoteM also includes a mobile option for continuous monitoring of medications and biomedical materials in transit between locations or even on mobile research vehicles (MRVs) used by some research teams. This can prove particularly useful for temporary facilities like ‘pop up’ vaccination clinics.

How RemoteM works

Clinical trials are vital in the development of new treatments and therapies, and it is important to retain consistency in order to harvest good quality data. Providing the ability to monitor frozen, chilled and ambient temperatures with total accuracy, to alert in the event of temperature and even power outages, to enable remote access to multiple sites and to retrofit existing equipment, RemoteM is a powerful and capable solution.

Why not organise a demo to see how RemoteM could work for you?