Simon Jones, VP Global Products, at PRISYM ID, explains how unique label management software is helping to get products into clinical trials quickly
A number of drugs are being tested in the UK’s Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial – the world’s largest randomised clinical trial of potential coronavirus treatments.
Elsewhere potential vaccines are being worked on at speed, including the University of Oxford’s primary vaccine candidate, ChAdOx1, which has gone from design to starting clinical trials in just three months.
To succeed in this time pressured environment, clinical trials companies need adaptive trial flexibility. But getting clinical labels designed and approved quickly can be a major barrier.
The lengthy, resource intensive process involved in clinical label design and approval poses a particular challenge when setting up clinical trials. This is because the label content not only varies according to the Investigational Medicinal Product (IMP) and trial protocol, but also in relation to country and regulator.
The common approach to creating Master Label Text (MLT) and Country Label Text (CLT) booklets is slow and cumbersome with many companies relying on disparate, outdated and unsecure systems – and sometimes even just spreadsheets and desktop word processing – to manage their label content.
Working in this way not only makes language labeling an onerous task that can take weeks or even months to complete, it heightens the risk of mistakes and omissions occurring on labels. It is also difficult to be flexible if label changes are required, in areas such as dosage and expiry dates, for example, or if a trial needs to be extended to additional countries.
Automatic labeling system
PRISYM ID provides the only labeling software designed specifically for clinical trials labeling, that enables companies to input IMP and protocol information, and then apply pre-defined regulatory rules and intelligence. The PRISYM 360 product enables compliant label and booklet designs and content to be automatically generated, which means that booklets can be created in less than an hour.
Clever print processes, incorporating industry best practice, can then support the need for any labeling changes that may be required once the clinical trial gets underway by providing access to the latest expiry dates and dosage requirements.
Batch or on-demand/just in time supply models can be used and labels printed for specific countries, using approved language translations.
To support clinical research organisations’ responses to the COVID-19 crisis and help them meet the urgent demand for treatments, PRISYM ID is offering instant access to a cloud-based, ready to use version of its of PRISYM 360 platform.
The PRISYM 360 SaaS Clinical Trials labeling solution is a pre-validated system, which removes a lot of the time associated with implementing and validating a labeling system, as well as the cost and risk. Indeed, it is so quick that companies can be operating live within a matter of days rather than months.
The solution comprises a pre-built software environment, including a pre-validated pack with industry standard print processes, rapid deployment and online training for employees.
As the world anxiously awaits the discovery of a treatment or vaccine for COVID-19, the ability to set up clinical trials quickly and then adapt them to meet changing needs will be critical to success.
In the past, the complex processes involved in clinical label design and approval, particularly language labeling and regulatory compliance, made it difficult for companies to be fleet of foot or flexible.
However, unique clinical labeling lifecycle software that enables companies to get MLT and CLT booklets completed in minutes rather than months and ensure regulatory compliance, is now playing a critical role in helping companies to rise to the challenge of COVID-19. Furthermore, clinical research organisations and pharmaceutical companies can now access this system instantly as part of PRISYM ID’s efforts to support them during the coronavirus crisis.
Simon Jones is VP Global Products at PRISYM