The journey of a new drug from scientific concept to NDA submission is fraught with complexities. The stakes are high: successful development offers the potential to save lives and revolutionize treatment, while failures can be financially devastating.
In this age of relentless innovation, the pressure to bring new drugs to market faster and more efficiently has fueled a rise in clinical trial outsourcing. Sponsors are increasingly leveraging the expertise of CROs to navigate the intricacies of global trials. Biotechs are leading the charge – investing twice as much in R&D spending than large pharmaceutical companies.1
Outsourcing offers several benefits for fast-growing biotechs, including access to strategic expertise, improved efficiency, and a global development engine. But, it also introduces a new set of challenges that sponsors must overcome because they are responsible for the trial’s integrity, safety, and success.
Hidden challenges in outsourced clinical trials
Despite CROs’ resources, reach, and infrastructure, sponsors often encounter obstacles when outsourcing trials that can impact timely study execution.
- Fragmented data: Data resides in various CRO systems, spreadsheets, and legacy databases, making it difficult to gain a holistic view of trial progress. Essential insights and trends can remain hidden, hindering informed decision-making.
- Communication silos: Silos can form between sponsor and CRO teams, leading to misunderstandings, delays, and quality issues. Critical updates can get lost, and timelines can slip due to a lack of clear and consistent communication channels.
- Oversight burden: Ensuring adherence to regulations across multiple CROs, each with its own processes and systems, becomes a major hurdle. The risk of inconsistencies and errors increases dramatically, diverting resources and focus from core trial activities.
- Inadequate technology: Many sponsors rely on tools like Excel, SharePoint, and data lakes to monitor the progress of their outsourced trials. These solutions aren’t built to handle the complex requirements of clinical trials, leading to data integrity issues and delays.
Are you at risk for a critical inspection finding?
Sponsors who are unable to show adequate documentation of their oversight can be penalized with severe fines from regulatory bodies.
Beyond the challenges, however, are effective solutions. A CTMS can act as a bridge, connecting disparate teams and data, fostering collaboration, and ensuring smoother processes.
Bridging the gap: the CTMS advantage
By providing a central platform for study oversight, communication, and information sharing, a CTMS eliminates silos, fosters real-time transparency, and ensures alignment across all trial partners. This improved communication and visibility allows for faster issue identification and resolution, accelerating the path to more efficient trials.
CTMS is the central hub where all pertinent information resides, creating a single source of truth. It eliminates the need to compile data scattered across disparate systems, improving accessibility for all stakeholders and providing a holistic view of progress across the portfolio.
Documenting a comprehensive oversight plan, a critical step for regulatory compliance, is straightforward with a CTMS. You can clearly define roles and responsibilities for both sponsor and CRO teams, monitor performance metrics to ensure CROs adhere to agreed-upon timelines, conduct co-monitoring visits, and capture all activities and communications to make compliance audits easy.
Why do I need a CTMS if a CRO runs my trials?
A CTMS centralizes planning, performance tracking, subject information, deadlines, oversight, and trial milestones in a simple and direct way. Having an auditable and reportable record of oversight activities is critical to satisfy regulatory requirements.
Taking control: leveraging a CTMS for successful outsourced trials
Sponsors can unlock several benefits by embracing a CTMS.
- Efficiency: Automate data transfers, optimize workflows, and collaborate on study execution. Manual data entry and extracts become a thing of the past, freeing sponsors to identify trends faster and focus on strategic initiatives.
- Visibility: Identify potential roadblocks early, adjust strategies on the fly, and make data-driven decisions that optimize trial success.
- Accuracy: Centralizing data minimizes the risk of errors, providing confidence in the integrity of trial data.
- Compliance: Alerts keep sponsors informed of upcoming deadlines and automatic document filing in eTMF ensures inspection readiness.
Oversight without overinvestment
Successful oversight is the result of harmonized people, processes, and technology. Technology supports both the data and processes, minimizing the effort required from people. For example:
- Automated data transfers maximize accuracy without manual intervention
- Workflows ensure that accountable personnel comply with appropriate steps
- Reports and dashboards provide an at-a-glance view of progress
- When a threshold is crossed, alerts notify teams to take action
Start with technology to ensure that data collection, process management, and reporting are handled well. With these foundational capabilities, oversight can become a positive opportunity rather than an expensive burden.
Selecting the right CTMS
Clinical trials are dynamic, demanding flexibility and adaptability. Selecting the right CTMS is a crucial decision that can make or break the efficiency and success of your trials.
The power of scalability: Your organization’s needs will evolve, so your CTMS should too. Look for a full-featured solution that addresses current requirements and accommodates future growth. Whether you handle trials in-house or outsource to CROs, a scalable CTMS ensures continued support regardless of operating model.
Connected clinical ecosystem: The right CTMS acts as a central hub, facilitating seamless data exchange and fostering collaboration. It also connects with other key applications to automate activities such as document filing in eTMF and study personnel training based on protocol updates and milestones.
Innovation is the engine of progress: Seek a CTMS from a forward-thinking provider with a commitment to continuous innovation. This commitment translates to a system that can adapt to changing regulations, industry best practices, and the ever-evolving needs of your clinical trials.
Key CTMS capabilities
- Maintain study roster
- Track investigator, vendor, and site information
- Manage study milestones
- Track enrollment
- Conduct monitoring oversight (MVR reviews)
- Manage issues and protocol deviations
- Document study oversight
- Collaborate on study execution
- Track trial trends and progress with real-time reports and dashboards
The Vault CTMS difference
Flexible
Easily support different operating models and study-specific needs in one system.
Unified and connected
Work seamlessly across data and documents and reduce integrations to drive cross-functional efficiencies.
Enhanced analysis and insights
Interactive dashboards allow users to move directly from insight to action to optimize trial performance.
Clinical trials are the engine for growth and innovation. With the right tools and strategies in place when outsourcing, you can bring life-changing treatments to patients faster and more efficiently, fulfilling the true promise of clinical research.
Contact us to explore whether your outsourced trials are efficient and compliant.
Contact Us1. 2022. McKinsey & Company. CROs and biotech companies: Fine-tuning the partnership.