The globalization of drug development has shortened the time to commercialization in key markets and expanded the availability of important new treatments. Before the ability to efficiently conduct a global clinical trial, separate region-specific trials were required in a number of major markets. Recent advances in technology, and collaborations among regulatory agencies, have shortened the time to gathering the data necessary for multi-region approvals. But globalization comes with a number of challenges that may be daunting for small and emerging biopharma companies. For these sponsors, there are advantages to partnering with a small global CRO. Here, we will look at PROMETRIKA’s solution to meeting the diverse regulatory requirements presented by global trials.
In most countries, health authorities must review and approve initiation of a trial in human subjects. In some cases, there are additional regional or local considerations. Meeting the regulations for approval requires full knowledge of documentation, language specifications, and legal requirements in each region in which the trial will be placed. Having local experts with deep understanding of the regulatory and legal landscape, current submission guidelines, and language requirements will make these processes as efficient as possible. But how can a small CRO provide such broad coverage?
PROMETRIKA has 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. When sponsors partner with PROMETRIKA for a global trial, PROMETRIKA conducts the global trial management utilizing 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.
Interaction with regulatory authorities requires senior level of expertise and knowledge. Like PROMETRIKA, our CRO partners have experienced regulatory personnel who actively engage in every project. In addition, communication plans across the CROs ensure that relevant information affecting all regulatory interactions are communicated in a timely fashion to all parties. Each CRO partner, PROMETRIKA included, recognizes their responsibility to keep the entire team informed of regulatory achievements or concerns.
We and our global colleagues share centralized tools and systems for each project. Tracking of safety events is managed in Argus, a recognized platform with direct submission capabilities to international regulators. Trial documents are housed in the CTMS and eTMF, to which all parties, including sponsors, have access during a trial. Our Regulatory professionals work closely with the Clinical and Regulatory teams across locations to identify all the items necessary for successful submissions. Working with smaller, more agile CROs such as PROMETRIKA and our global associates provides sponsors with personalized attention in combination with global reach.
