Improve Your Labeling to Speed Up Clinical Trials
by Diana Headrick, on June 23, 2020
In the race for treatments and vaccines for the COVID-19 virus, pharmaceutical companies are working around the clock to deliver solutions in less time than was previously possible. Clinical trials include four main phases with expanding numbers of test groups and normally run for years; final FDA approval to bring a drug or a vaccine to market averages five to seven years. With the current crisis, companies are now hoping to shorten that cycle to less than 18 months.
Accompanying scientists’ efforts to develop, test and analyze the results of investigative new drugs (IND) are parallel efforts in the pharmaceutical supply chain. Under equivalent time constraints, manufacturing and supply chain managers are preparing to bring these products to market for testing, and, when approved, for full production. The challenges to meet these constricted timelines are equally immense.
Clinical Trial Label Requirements
The first step in making an IND available for clinical testing is the label. Both the EU and the United States have strict regulations requiring specific information that support patient safety and enable traceability of results. These include the name, address and telephone number of the sponsor, as well as the trial reference code on the label of an investigative medicine for a clinical trial. The complexity of this data expands as the trial phases progress to include more patients and more investigators across a wider global landscape. The content of the label, which will vary depending on if it is an open or a blinded trial, must include translations for the local languages used in the country in which it is tested. As the trials progress, content on the label, such as the directions for use, or the medication warnings, may require updates based on new information from previous results. Additional data, such as lot numbers and manufacture and expiration dates, can only be added to the label when it is printed.
The clinical trial label is a critical tool both to track the use of the IND as well as protect the patient. Accuracy is essential to guarantee proper traceability and ensure valid results. Creating accurate labels can take months, especially when factoring in the different data and language requirements in each testing country. Many companies still rely heavily on spreadsheets to manage translations and other required content and use emails for the review process. Not only are these methods time consuming, they risk introducing errors into the process and lack auditability. In today’s challenging environment, time is of the essence and accuracy and traceability cannot be sacrificed.
Reducing Labeling Errors by 95%
To shorten the time required to develop clinical trials labels without sacrificing accuracy or compliance, forward-thinking organizations are implementing solutions that combine Enterprise Labeling with Artwork Management. Integrating these solutions enable companies to manage required content and translations, drive labeling layouts and content based on business logic, integrate solutions with enterprise applications, streamline approval processes, and track and report changes for auditing purposes. One such company, a global leader in the pharmaceutical industry, was able to cut the number of labeling errors by up to 95%. Furthermore, it was able to reduce the end-to-end lead time to produce clinical trial labels by 50%, reducing label inventories and dramatically lowering their total labeling costs along the way.
Providing Solutions for Clinical Trial Labeling Today
The COVID-19 crisis has forced many in the pharmaceutical industry to drive parallel efforts in research and supply chain management to shorten the time required to develop, test and produce new treatments and vaccines. Loftware partners with a range of leading life sciences companies to provide the labeling and artwork management solutions necessary for them to meet their evolving demands. When it comes to clinical trial labeling, Loftware understands the requirement for flexible and scalable solutions that reduce errors, increase accuracy and enable compliance and auditability during the design, review and approval process for clinical trial labels. Learn more about Loftware’s solutions for pharmaceutical labeling, clinical trial labeling and IFU/eIFU management.