Outsourcing Clinical Trial Activities Without Sacrificing Study Oversight

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.

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.

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.

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. 

Bonne Adams is the vice president of operations at Inhibrx Biosciences, a clinical-stage biotech with a lean team of 17 clinical and four IT employees. Even though Inhibrx outsources 75% of its studies to CROs, Adams still views the company’s CTMS as essential. “The CTMS is your base system for setting up all other systems. Study metrics, global contacts – they all flow from your CTMS to other systems,” Adams explains.

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.

“The CTMS is your base system for setting up all other systems. Study metrics, global contracts – they all flow from your CTMS to other systems” Bonne Adams, vice president of operations, Inhibrx Biosciences

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.

The manager of clinical trial systems at a biotech that outsources 60% of its studies to CROs, started small when first implementing a CTMS. “Your process should be really simple to start, and that’s how you can scale up,” he advises. “We started by having everyone write their oversight monitoring reports in Veeva CTMS. Then, once they felt comfortable, we asked people to also put their KPIs in. Next, we moved on to risk management and more.”

The company’s clinical team also uses CTMS Transfer to easily receive data from one of their CROs. This feature automates the daily transfer of study data from its CRO, providing the team with secure, read-only access to their trial data. “With CTMS Transfer, we maintain oversight and visibility while allowing the CRO to leverage its own Veeva CTMS,” says the manager of clinical trial systems. “It saves us significant time, effort, and costs associated with manual data uploads and reconciliation.”

“Your process should be really simple to start, and that’s how you can scale up. We started by having everyone write their oversight monitoring reports in Veeva CTMS. Then, once they felt comfortable, we asked people to also put their KPIs in. Next, we moved on to risk management and more.” Manager of clinical trial systems at a late-stage biotech

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.

For example, as the late-stage biotech grew to over 500 employees, the organization’s needs changed. “We've had to upscale, but we have been able to do it without losing the integrity of the solution,” says the company’s manager of clinical trial systems. “Having a validated system like Veeva CTMS is much better for scalability and repeatability. It is so much easier to run reports and have top-level oversight.”

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. 

At Inhibrx, Adams has seen the financial and time savings of having a connected platform. “I’ve looked at our budgets, and we save a lot of time and money by having connected solutions like Veeva’s. Plus, there’s no redundancy anymore. The effort it takes to manage the systems goes down drastically,” she explains.

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.

The Veeva 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.

“Having a validated system like Veeva CTMS is much better for scalability and repeatability. It is so much easier to run reports and have top-level oversight.” Manager of clinical trial systems at a late-stage biotech