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Clinical trials
Pharmaceutical industry
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Clinical trials

Ensuring the success of your clinical trials

Ensuring the success of your clinical trials

The logistics of clinical trials is complicated by the fact that knowledge of the reaction of the product under unusual environmental conditions can be incomplete. Clinical trials have an impact on human lives and so it is essential to find transport solutions within cold chains that are extremely reliable at every stage of the trial.  With 40 years’ experience in the pharmaceutical cold chain, Sofrigam is there to assist you in the success of your clinical trials.

The advance of clinical research

Our expertise is in maintaining the temperature of pharmaceutical products and highly sensitive biotechnological products, to help your innovations.

Whatever the logistic circuit, whatever the temperature, whatever the constraints … the solutions that Sofrigam packaging can provide will reduce the risks and guarantee the maintenance of the cold chain.

From development to commercial application, the Sofrigam cold chain packaging will help ensure success in your clinical trials.

Securing the logistics of the Clinical trials from start to finish

Biological matters, specimens, samplings … each phase of a clinical trial necessitates an adapted transport solution. Let Sofrigam join you on each and every stage of your project:

  • Active packaging solutions allow the transport and storage of trial clinics at the correct temperature to and at the heart of investigation.
     
  • The insulated pouches ensure the maintenance of the cold chain of the medicinal products right up to the point of them being administrated to patients.
     
  • The UN3373 qualified cold chain boxes can guarantee the safe transport of specimens and biological samplings in Category B from the investigation centre to the analysis laboratory.
The objectives
  • To transport safely the active pharmaceutical ingredients (API), the specimens, biological samplings and the experimental medication (IMP) in total security. This requires both active and passive. transport solutions within an adapted cold chain.
     
  • To offer packaging solutions that meet even the most demanding statutory constraints of the industry (Afnor, ISTA, WHO)
     
  • To dispatch the biological samplings and specimens within Regulation UN3373 covering the transport of Category B products.
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Competence Certificate – examining the impartiality and the independence of a certifying body, according to the norms in force. Through accreditation, an authoritative body formally recognises that an organisation or individual is competent to carry out certain tasks. Accreditation establishes a large degree of confidence in the body’s ability to issue certifications, representing confirmation from the relevant organisation. The certificates, delivered by those accredited to do so, are thereby endowed with complete trust and credibility on the market.
Crate or insulated container equipped with the Coldway Inside° refrigeration production system (usually in the upper part).
Insulated mobile crate equipped with Coldway Inside° refrigeration system (in its lower part).
The title of this regulatory reference is: ‘Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use’ (2013/C 343/01). This document is issued by the institutions, bodies and organisations from within the European Union. It fixes the rules in respect of the distribution of medication (storage, transport, sub-contracting, etc.).
CertiCold is a quality label for cold chain products delivered on the basis of private technical specifications and established in conjunction with the relevant manufacturers and the professional users. The label CertiCold Pharma relates to cold chain equipment for health products – for packaging solutions for the transportation of health products and for transport units under controlled temperature for health products.
Procedure by which a third part gives written assurance that a product, process or service conforms to specified requirements.
This is the full method used to maintain a product at a constant temperature throughout the transport process, all the way to its final destination.
An autonomous, active refrigeration system using the technology patented by Coldway Technologies. The Rolls and active Containers are all equipped with this technology, facilitating constant and controlled refrigeration which is both silent and de-carbonised.
This is a measuring device which records and stores temperature readings. It is equipped with a temperature probe, memory storage, a display system and alarms. Some recorders can also communicate the results in real-time.
Packaging case (or box or container) comprising of a thermal insulation on each wall to reduce heat exchange with the environment.
Insulated box equipped with a refrigeration source (refrigeration accumulators). The refrigeration source may be eutectic plates or phase-change materials (PCM) or even dry-ice.
The pharmaceutical supply chain from start to finish, or End-to-End, involves the logistical operations of transporting and storing medication, from the manufacturing site to delivery at the health facilities such as clinics, hospitals, and dispensaries – and in some cases even to the patient himself.
The eutectic plates are water-based thermic accumulators (for cold or heat). The aqueous solution facilitates the stocking of thermic energy in the solid or liquid sensitive phase and by the changing of the solid/liquid phase. With fusion temperatures below or equal to 0 °C, the eutectic plates permit the maintenance of temperature differences between +2/+8 °C, under -5 °C, under -15 °C, under -18 °C or even under -20 °C.
A characteristic of a material represents its aptitude to accumulate a greater or lesser amount of heat for a given variation in temperature. The thermal inertia of a material depends on its density, thermal conductivity and mass heat.
This material is characterised by its low thermal conductivity. The most commonly used insulating materials in the manufacture of isothermal packaging are: - Polystyrene – the traditional thermal insulator whose thermal conductivity varies between 0.03 and 0.045 W.m-1.K-1. There are two notable versions: expanded polystyrene and extruded polystyrene. - Polyurethane – is the best classical thermal insulator. Its thermal conductivity varies between 0.02 and 0.025 W.m-1.K-1. - Vacuum Insulated Panels (VIP) – a super-insulator in the form of vacuum panels.
This is the last stage in the logistics journey, culminating in the final destination. Health professionals and patients are an integral part of that last mile logistics.
“A document established by consensus and approved by a recognised organisation, that contains – for common and repeated use – regulations, directives or characteristics for activities (or their results) guaranteeing an optimal level of order in a given context” (a definition as set out by the ISO – International Organisation for Standardization – and the CEI). The norm is an indisputable standard on a given subject, suggesting technical and commercial solutions and used to simplify contractual relationships. To be considered as a norm, the document must fulfil two conditions: the means and the methods described must be reproducible, by using and conforming to the conditions indicated, and they must be recognised by all. In a general case the application of a norm is facultative but the law or regulations may render it obligatory. It may also be imposed by the principal to fulfil a contract.
Normalisation is the process by which norms are published and promoted. According to French regulations, the object of ‘normalisation’ is “to supply the reference documents containing solutions to technical and commercial problems concerning the products, goods and services that occur repeatedly within the relationships between economic, scientific, technical and social partners” (Decree n°84-74, 26/01/1984).
A patient-centric approach is one in which the patient is placed at the very heart of the health care system. It is based on a partnership between the patient, his family and the health professional to travel on an adapted treatment pathway together. Professional expertise and patient experience – acquired little by little throughout his life – are linked as both of them learn from the patient’s health and psycho-social problems, the illness itself and its implications on his lifestyle and that of his close family. This approach helps the patient to obtain self-caring skills, being able to adapt and manage his illness. through listening, monitoring and receiving support from the professionals throughout his treatment.
The phase-change materials (PCM) are materials that allow the storage of thermic energy by the solid or liquid sensitive phase and by the change in the solid/liquid phase. With fusion temperatures over or equal to 0 °C (positive), the PCMs allow the maintenance of the temperature differences between +2/+8 °C, +15/+25 °C as well as other specific temperature differences under specific hot or cold outdoor temperatures.
A temperature profile simulates the variations of temperature in a logistics circuit, from the moment the packaging is loaded until it is unpacked. The temperature profiles can be cyclic and composed of segments, or remain at a constant temperature. Some standards allow for pre-determined levels, others leave the choice and the responsibility to the user and the manufacturer.
The qualification relates to equipment such as cold chain packaging. It consists in showing, in a documented manner, the aptitude of the solution to meet the specific demands using norms or specifications. It confirms the performance of the solutions in pre-defined conditions through laboratory tests.
This is the optimum temperature to maximise and maintain healthiness and the security of the products inside an isotherm container.
This sensor contains a sensitive element to measure the temperature. A number of technologies involving temperature sensors exist. The most common are resistive probes (Pt 100 for example) and thermocouples.
This is a captor with a sensitive element which monitors temperature. Several temperature probe technologies can be seen working here; the most used are the resistive probes (such as Pt 100) and thermocouples.
Thermal stabilisation of a materiel is the maintenance of the temperature and its state at a predefined temperature.
Thermal stabilisation of a material is the conditioning of its temperature and its state at a predefined temperature.
This is a financial estimate covering the direct and indirect costs generated by the ownership and use of a product. For an isotherm packaging solution the calculation of the TCO will reveal the global financial impact of the solution. The purchase price is just one part of the global implementation cost, as transport, storage and preparation cost must be added – as well as conditioning and repatriation charges should the solution be reusable, After Sales Service is an additional expense to be considered, as are costs related to security risks such as loss, theft and temperature excursions.
This is a test carried out with an insulated or cooling packaging in a thermostatic case – this simulates the variations of the environmental temperature. It is then possible to qualify the thermal performance of the packaging by simulating various temperature changes in the surrounding environment. It is thus possible to qualify the case’s thermal performance and to check the capacity to maintain temperature-sensitive products within a required range of temperatures for a given period and a pre-defined temperature profile.
The validation relates to the complete transport procedure using the temperature-controlled packaging boxes. It consists in verifying and confirming in a documented way that the solution functions correctly in real-time conditions.
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