Compliant Clinical Label & Booklet Design

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Richard Adams
Richard Adams, CEO

PRISYM ID

 

“PRISYM ID provides the only labeling software designed specifically to streamline the process of producing clinical trial labels and booklets. Based on the Investigational Medicinal Product (IMP) and study protocol, PRISYM 360 applies predefined rules to automate the selection of country-specific label content, including indications, warnings, precautions, symbols, dosage, as well as language translations.”

A key challenge in clinical supplies labeling is the creation of clinical studies booklets, a process which can be slow and time-consuming, with many clinical supplies functions relying on disparate or outdated systems to collate the necessary content. As clinical studies often include clinical sites or patients across many countries, the diverse regulatory and language requirements make this an onerous task that can take weeks or even months to complete. It also heightens the risk of possible errors or omissions occurring on labels or booklets. Furthermore, as Regulatory Bodies change the labeling requirements for clinical trials performed within their countries, ensuring continued regulatory compliance of ongoing studies represents a significant operational overhead.

PRISYM ID provides the only labeling software designed specifically to address the complexities of clinical study labeling; its PRISYM 360 platform delivers innovative content management features which incorporate industry best practice, designed specifically to meet the highly complex regulatory requirements of clinical trial labeling.

Master Label Text /Country Label Text (MLT/CLT) functionality, Regulatory Rules and Phrase and Language management features enable labels and booklets to be designed quickly and accurately, whilst Approvals workflows streamline the review and approval process vital to assuring optimal delivery.

Richard Adams, CEO of PRISYM ID, says, “PRISYM ID is the only organization of its kind globally and it was clear to me that its unique labeling and regulatory information management technology can redefine these critical components within life science supply chains. Getting clinical study labels and booklets right is essential in assuring regulatory compliance, and more broadly it underpins the success of clinical studies and patient outcomes.”

According to Richard, the complexity of Investigational Medicinal Product (IMP) and study protocol data, the extensive regulatory and language labeling requirements, and the breadth of countries often included in a trial, create a content control challenge that ERP systems are unable to meet. PRISYM ID has collaborated closely with clinical supplies teams on the development of its software, incorporating this industry best practice, to address the specific clinical trial labeling challenge.

Finally, with a surge in clinical studies of potential Covid-19 vaccines and treatments, PRISYM ID has leveraged its SaaS platform to enable new customers to access its unique technology quickly and easily. Being Cloud-based, it is quick to onboard and needs minimal in-house IT set-up. And being pre-validated, the application removes a lot of the cost, time and risk associated with implementing and validating a labeling system.

In the future, PRISYM ID will continue to listen to its customers and bring new innovations to market to help manage their global labeling challenges. In particular, it will focus on helping medical device and life science industries remove risk, enhance efficiency and deliver their ultimate goals of safe, effective patient outcomes.

“We know we need to invest in attracting and developing great talent to deliver on our promises. We will also look to extend our geographical presence to ensure our products and services are more widely understood and to provide companies with the chance to benefit from our industry focus and leadership in our class,” says Richard.

“Since labeling now falls, in many eyes, under the broad umbrella of Regulatory Information Management Systems, we will work with clients to leverage their existing investments in our solutions to extend their benefits to other use cases beyond labeling.”

“Maintaining a single version of the truth for regulated content has numerous benefits and PRISYM ID will be at the forefront of enabling its customers to capitalize on those business advantages,” he concluded.