We had a great turnout for the February 14th webcast on “The Joys and Woes of Clinical Trial Startup: A Global Perspective.” During the live event, we polled participants to learn what part of the global start-up process was their greatest pain point. Here are the findings:
What part of the global start-up process is your greatest pain point?
- Figuring out efficient processes all around (30 percent)
- Regulatory submissions and approvals (22 percent)
- Negotiating contracts or budgets (20 percent)
- Identifying sites (14 percent)
- Working with your sponsor/CRO/site vendor (14 percent)
I wasn’t surprised to see that creating and executing efficient processes was the biggest challenge faced by attendees. This is no small task when key stakeholders are dispersed across the globe and are sometimes using disparate technologies and systems. It is paramount that strategies be put in place to ensure information is not put in silos and all activities are fully tracked. Whenever possible, create a visual flow-chart that can be shared across teams and train using the “hear, see, do” method. Finally, technology-amplified solutions and service-delivery methods such as those offered by Clinipace ensure that all stakeholders are working from one common platform, looking at the same data in real-time – maximizing efficiency across all global teams.
Regulatory submissions and approvals was the second leading pain point. When starting a global trial, keeping up with the latest regulatory changes across different jurisdictions can be a daunting task. Working with an experienced global CRO whose Regulatory and Strategic Development team has local experience and good working relationships with the regulatory agencies is key.
They can help you submit final documents to regulatory bodies and create country-by-country flows (with CA, EC, contract, budget, insurance and other relevant information).
One common issue woven across a multitude of answers was the need to stick to timelines.
As pharmaceutical and biotechnology companies strive to increase productivity while cutting costs, optimizing trial start-up timelines has become a hot topic around the globe. Companies can positively impact start-up timelines by writing clear, concise protocols, considering global differences, and accepting the need for flexibility in site-specific issues, such as informed consent language and contract term.
To learn more about how to streamline to the global start-up process, watch the webinar in its entirety by visiting http://ow.ly/i2ldO.