More than 64% of the trials posted on clinicaltrials.gov include at least one country outside of North America. For American-based sponsors, expanding trials outside the scope of North American regulators raises concerns around regulatory compliance, logistical methods, and participant wellbeing. Overarching all of these challenges is the question of how well international trials can be managed. PROMETRIKA has developed a management model to ensure informed and efficient communication and activities during global trials.
PROMETRIKA has formed strategic partnerships with like-minded and similarly sized local CROs in over 80 countries on 5 continents. These relationships have established guidelines for working together in the sponsor’s best interest. For a US-based sponsor, PROMETRIKA remains the global management CRO and utilizes the deep regional expertise of our partner CROs. We have created a culture of global community, which ensures that the sponsor’s goals are addressed seamlessly on the international platform.
Sponsors need to know they are selecting the right CRO for their company and for the specific trial. PROMETRIKA has designed its global strategy around five key pillars.
- Strong global oversight and deep local expertise
- A tailored approach and a commitment to partnership
- Streamlined communication
- Advanced technology and processes
- Flexibility and agility
When a North American sponsor is leading a global trial, PROMETRIKA’s Global Project Manager (GPM) is based in the US. Project Managers and other leads outside the US respect the leadership of the GPM, contributing to continuity and efficiency across the entire project. These local experts take responsibility for activities that cannot be wholly performed by the US-based CRO, such as site management, clinical monitoring, local vendor management, and addressing local regulatory obligations. A single set of standard operating procedures (SOPs) are used across the globe and all team members utilize the same technologies and tools.
The communication structure and methods are determined at the beginning of the project. Regular global project team meetings support knowledge sharing and relationship building. And local team meetings cover methods for decentralized execution and agile conduct of the trial.
Project team communication is only one part of successful project management. It is vital that the sponsor, third-party vendors, and study sites interact openly and effectively to maintain the quality of the trial, its timely completion, and the cost. Allowing sites to be part of developing effective communication, and allowing participants to give advice and feedback, enhance the aims of the sponsor.
The advanced technologies and updated processes currently available can help ensure that data are accurate, cohesive, and appropriate for the targeted analyses. Additionally, through technological advances and decentralized processes (e.g., wearable devices, remote monitoring, telehealth), sponsors can have near-real time views of trial data. These capabilities help identify any emerging risks to data or study integrity, allowing the project team and sponsor to make necessary corrections.
Despite careful pre-study planning, the sponsor’s needs may shift, expectedly or unexpectedly, during the trial. An effective CRO needs to be agile and flexible; able to quickly adjust workflows or methods to keep the trial on track. Here again, strong sponsor, CRO, vendor, and site communication are the key to an agile trial.
These are just a few examples of the CRO’s capabilities a sponsor must consider in making an effective choice for their project.
