Simplifying Global Clinical Trial Labeling through Automation
The Current Landscape of Clinical Trials in Biotech and Pharma
The contemporary landscape of clinical trials is marked by an increasingly complex clinical supply chain. As trials expand globally, diverse regulatory challenges and logistical hurdles demand meticulous management to maintain timely delivery and international standards compliance. This globalization escalates the complexity of clinical product data management, with each nation's differing regulations requiring accurate, current, and compliant labeling across various languages and formats.
Clinical trial labeling, vital for compliance and patient safety, also faces challenges in this multifaceted regulatory environment, with labels needing to fulfill country-specific requirements including language, dosage, and legal disclaimers. The need for constant label updates as trials progress further complicates compliance, with non-adherence risking delays, product waste, and legal repercussions.
The Challenge for Smaller and Emerging Growth Sponsors
These complexities disproportionately affect small to medium-sized enterprise (SME) biotech and pharma companies which often operate with limited resources. They must maneuver through a maze of international regulations and manage multilingual data and label compliance, all while establishing a foothold in a competitive market where funding is often tied to achieving critical clinical trial milestones.
Labeling management systems to ease this burden have traditionally been too complex and expensive for all but the largest sponsors and CDMOs. New Software as a Service (SaaS) solutions now offer an alternative, bundling the key elements of project coordination, translation, regulatory compliance, and change management into a single platform.
Streamlining Labeling and Documentation
Ensuring the accuracy and compliance of multilingual and multiregional labeling is a formidable task, compounded by the necessity of frequent updates as trial data evolves. Streamlining these processes is not just about efficiency; it's about ensuring the integrity and success of your trials.
Each country where a trial is conducted may have different labeling regulations, including language-specific requirements. Ensuring that each label is accurate, compliant, and tailored to the specific region can consume significant time and resources. This complexity is further amplified when considering the need for frequent updates to labels as trial data changes, requiring a flexible and dynamic approach to labeling.
Solving for the 4 Main Challenges of Global Labeling Projects
In our work with sponsors and CMOs, four recurring challenges of global labeling projects come up time and again:
Project coordination
Maintaining approved phrases across multiple languages
Keeping track of regulatory requirements
Change management and version control
Let’s look at each of these challenges individually and see how a unified solution pulls all the elements together.
Project Coordination
Many sponsors are still utilizing Excel spreadsheets, email, and cutting and pasting to manage labeling projects. This methodology is inefficient, resource intensive, and prone to errors, putting your project and company at risk. Manual coordination of activities also leads to delays that translate to longer time to dose and lost revenue.
There’s a better way, with labeling management systems providing the seamless integration of project management, action items, messaging, and status dashboards. Sponsors are realizing time and cost savings using this integrated set of tools to streamline their activities, collaborate with vendors, and reduce errors.
Maintaining Approved Phrases across Multiple Languages
One of the biggest challenges faced by sponsors as their trials grow in scope and geographic coverage is keeping track of translated phrases. Trials are often expanding into a dozen or more countries in Phase 2 and sponsors need to assure only the most up-to-date, accurate, and approved translations are being used.
Third party translation management systems (TMS) are designed for marketing purposes, with few solutions built for life sciences applications. The best solutions for sponsors interweave translation management functions with a regulatory rules engine to ensure translated content is aligned with the country requirements of where trials are being conducted.
Keeping Track of Regulatory Requirements
Complexity of clinical trials grows with each new country a site is added in. While there is a myriad of regulatory compliance activities that need to be handled in terms of registering trials and submitting applications and trial data to regulatory bodies, there are many often overlooked labeling requirements that must be adhered to. The information required on labeling differs from country to country and failure to get the right data in the right format can lead to delays and other consequences.
Sophisticated label management solutions incorporate global regulatory requirements into a seamless rules engine, freeing up sponsors from the burden of tracking regulatory updates and changes. Sponsors are guided through what data is required and in what format as label projects are created, flagging errors and missing fields, prevented from using non-compliant formats.
Change Management and Version Control
To paraphrase a time-worn adage, the only constant in today’s clinical trials is change. As trials progress and findings are gathered, fulfillment, and subsequently labeling, requirements change. This is especially true for biologics with their large molecule volatility. These changes can wreak havoc on the best laid out supply chain planning. As new sites are added, new regulatory and translation requirements can stack up. The time required to track how your labeling content meets changing requirements can cause delays, waste and derail critical deadlines.
Label management solutions integrate change management and version control to assure fulfillment stays on track and milestones are met. The impact of changes are automatically assessed and guidance provided on what adjustments to labels need to be made to meet the regulatory requirements of new countries, while version control assures only up to date and approved phrases and translations are used.
Bringing it All Together
Streamlining labeling and documentation for clinical trials is a critical challenge, especially given the complex nature of today’s global clinical supply chain. As we’ve seen, the time-intensive, error-prone approach of managing increasingly dynamic clinical trials labeling with spreadsheets and email isn’t sustainable. Fortunately there are now integrated solutions that solve for the main challenges of project coordination, multilingual phrase management, tracking and adhering to changing regulatory requirements, while maintaining change and version controls. An automated approach is now in reach of sponsors of any size or at any stage of development, through streamlined, cost-efficient solutions. These can be deployed in a matter of weeks, enabling a rapid path to achieving significant improvements in efficiency and risk mitigation.
We're introducing a better way to manage clinical trial labeling and would love to hear from you
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