The importance of controlled conditions for clinical trials

Investigational Medical Products (IMP) are often vulnerable to temperature fluctuations that can cause catastrophic impact during clinical trials. Medical products can easily become less effective, totally ineffective or even dangerous when exposed to unacceptable environments. Current guidelines suggest that a member of the clinical trials team records the temperature of the storage conditions daily (excluding weekends and bank holidays). Of course, things never go wrong on a weekend or bank holiday do they?

So how can researchers maintain confidence in their products effectiveness if environmental conditions are not strictly monitored and logged every day (including weekends and bank holidays)?

Dedicating staff time to manual record keeping during clinical trials is not only limited by staff working hours but can also remain open to human error and cost time and money that can be better spent elsewhere. Similarly, downloading data from loggers only inform researchers of temperature breaches and failures after IMPs are exposed to them potentially costing departments more time and money in product replacement.

Affordable wireless temperature monitoring technology is easily accessible to so many of us now that it seems illogical to do anything else, doesn’t it?

A wireless monitoring system is like an insurance policy, ensuring researchers adhere to watertight regulations without actually having to do much other than react to immediate temperature alarms or file report printouts for audit trials.

Hanwell provides temperature monitoring equipment that adheres to 21 CFR Part 11 and MHRA regulations and provide calibration certificate at initial purchase and annual calibration in-house or on-site thereafter.

Contact us on 01462 688070 and speak to our Healthcare Business Development Manager for further advice on temperature monitoring for clinical trials today.

Hanwell – Established within Healthcare for over 25 years