A Critical Mission: Clinical Trial Material Storage

Posted on June 20, 2016

Clinical Trial Material Storage

Storage of Investigational Medicinal Products (IMPs), ancillary supplies and patient samples is a process that requires careful planning, and it is subject to change at every stage. There is a lot at stake for both sponsors and Clinical Research Organisations (CROs) and/or Central Laboratories, from being responsible for IMP’s that represent millions of dollars in investment to the health and safety of patients participating in the clinical trial. The appropriate storage and distribution of such sensitive products can be challenging and should be carefully planned and managed prior to and during the execution of the study.

Generally during the planning stages of the study, Project Managers should clarify essential questions to prepare for the successful storage and logistics of all clinical trial materials at any time. The first step is to identify the parameters that affect quality and stability of. These should include: product stability data and shelf-life; available product quantity; frequency of administration; storage conditions (e.g. controlled refrigerated 2-6°C); study length and planned enrollments.

Temperature excursions during the storage of temperature-sensitive clinical trial materials pose major safety and financial risks, including:

  • Patient could be administered an unsafe product
  • Increasing liability due to lack of compliance
  • Inconsistency of results due to thermal variability
  • Loss of unique patient samples

Arguably one of the highest risks can be identified as “loss of samples”. Due to the unique character of the samples, they are highly valuable and irreplaceable. At no other point in the future will it be possible to collect another sample at the exact same conditions. As a result, storage conditions of samples should be planned carefully and monitored at all times.

Storage conditions can be complex to plan ahead, because of the many variables impacting temperature in refrigerated or frozen conditions. Large facilities, such a CRO’s or Central Laboratories, generally operate large walk-in refrigerators or freezers, which are well monitored. Participating clinical trial sites, however, more often than not don’t have access to similar secure facilities. Investigators will have to rely on a compact fridge or freezer for temporary storage of the IMP or patient samples.

MediCapital Rent is here to help

For the past 20 years, MediCapital Rent has been carrying the slogan “Your reliable partner in clinical research”. This is a commitment we take very seriously, so we don’t just offer rental of temperature control and monitoring equipment, but we can help plan according to the study requirements.

We know that storing 5 boxes of IMP in a 2.5 cubic feet refrigerator has another effect on the internal temperature, then storing 20 boxes in the same refrigerator. Opening a door once a day, or 10 times a day and storing liquids or solid materials, all have an effect on the temperature conditions of the refrigerator and how long it will take to “recover” after an event.

When renting refrigerators, freezers and/or incubators from us, we will provide the exact same type of equipment to each site in a continent, to eliminate any variability that could be caused by equipment specifications. Before a study starts, we are there to help select the correct equipment and even run test setups to measure the effect of storing certain volumes of samples or IMP in the equipment.

For critical applications, we offer various systems to constantly monitor temperatures and/or humidity that will keep meticulous temperature records over time and can even alert the investigator, the site monitor, and the project manager whenever an excursion occurs.

So now: when you are planning temperature controlled storage for your next study, please don’t hesitate to contact us and discuss with one of our product specialists how we can help you to keep your clinical trial materials safe!