In this blog, PRISYM ID’s Clinical Trials Sales Manager Bob Bowdish looks at the challenges of in-sourcing label management processes for CDMOs, and explores how they can be overcome by investing in a cloud-based, validation-ready labeling solution.
Stick or twist? It’s one of the big dilemmas facing contract development and manufacturing organizations (CDMOs) today: to what extent should they specialize tightly around a core offer versus providing a full-service solution to sponsor organizations by bringing a wider range of services in-house.
Many are opting for the latter. The last eighteen months has piled pressure on CDMOs to deliver faster and better. The post-pandemic customer has seen the impossible made possible over the last eighteen months in terms of radically accelerated delivery times – and now expects more of the same.
When speed and efficiency matter so much in the clinical trials landscape, CDMOs of all shapes and sizes are being tempted to claw back time by smoothing gaps between concept development and design, the distribution of products through trial phase and the transition to scaled up production after regulatory approval.
Additionally, as outsourcing expert Rich Panicucci has pointed out, the trend towards the consolidation of CDMOs into large conglomerates has created a critical gap in the market, with orphan drug often de-prioritized by the bigger firms in favor of high volume products that carry a better margin.
Growing pains: the perceived barriers to in-sourcing label management
Yet for small to medium sized players now looking to fill that gap by scaling up their operations, there are some significant risks, particularly when it comes to taking on responsibility for manufacturing, labeling and distribution of products.
The ones that tend to be cited most often are:
• Financial challenges: i.e. taking on responsibility for labeling and distribution often carries a hefty upfront cost, which can be a difficult sell to nervous Chief Executives and Financial Directors.
• Corporate resistance: i.e. bringing more services in-house is a significant ‘project’, which requires new recruitment and expends corporate resource as it essentially means creating a new line of business.
• Skills shortages: i.e. smaller enterprises are less likely to have people with the technical skills to lead complex implementation of new IT systems, creating risk to business continuity if things go awry.
Easing the pain: how can the label management software address these challenges?
The benefits of adding labeling as a service are strong. It provides competitive advantage by reducing time from lab to patient, addresses sponsor needs to reduce suppliers and offers new revenue stream.
It can also allow CDMOs to increase flexibility, respond faster to customer requests while reducing costs and increasing margin – and there can be further competitive advantage by speeding up response times through label and booklet design and print automation.
So how do you address the barriers outlined above?
Firstly, the efficiencies driven by the system will reduce the number of people that you would have to hire. And, once you’re up and running the system will provide benefits and margin that would quickly overcome the cost of the solution.
While the numbers will vary, it doesn’t take much imagination to see that if your booklet labeling currently takes, for example, 12 days using manual methods and a label software system can reduce that to just six hours then the savings will very quickly gobble up the initial investment.
Secondly, consider the risks of the alternatives. Outsourcing the labeling and distribution process creates additional time pressures that are increasingly unpalatable to the post-pandemic customer so you may lose business opportunities as a result.
Meanwhile, relying on quick-fix, paper-based methods of assuring label content are both time-consuming and risky. A single label error can cost many tens of thousands of dollars in recalling products. Being audited for regulatory processes could delay or halt production entirely as teams scramble to access paper-based records. Investing in a content and label management system is a security against human error and the risk of non-compliance.
Finally, the implementation of our content and label management systems can be made simple through cloud-based services. PRISYM 360 – Clinical Trials Cloud is a validation-ready out-of-the-box solution that can be quickly deployed to support the development of label content, design and print of labels. This minimizes the time and in-house skills needed to oversee implementation. This case study describes how quickly a cloud-based solution can be onboarded, configured, and made operational.
In short, the pandemic has helped to rewrite the rule book in terms of increasing the agility and speed in which the pharma and biotech sectors work. Expectations remain high, with CDMOs increasingly adapting and growing their service lines to meet them.
We believe that investing in label and content management software can and should be a major part of the solution, helping CDMOs to mitigate risk, ensure compliance and rapidly deliver a return of the initial outlay.
To learn more about how PRISYM ID can help you build your organization’s in-house labeling capabilities, e-mail email@example.com.
About the author
Bob Bowdish, Clinical Trials Sales Manager, PRISYM ID
Bob Bowdish is Director of Clinical Trail Sales North America at Prisym ID. He has over 25 years’ experience in the life sciences in commercial and research development. His last five years has been helping life science companies leverage regulatory and clinical software to realize efficiencies that result in delivering treatments to the patients they serve.
Bob’s diverse healthcare experience gives him the insight on how regulatory and clinical data can contribute to commercial success. This insight has proven to deliver innovative software solutions that have shortened time to market and enhanced patients safety.