With study protocols are becoming more complex with changes that require amendments it is crucial to find a partner that can define, build, test, confirm, and deploy quality studies.
Patient compliance was a serious concern, particularly regarding the reduction of sun exposure. Running a dermatology trial, especially in the middle of summer, can greatly affect patient compliance and the resulting, potential flare-ups in any dermatological condition. Read how implementing various layers of risk mitigation can assist in offsetting any foreseen compliance issues.
CNS trials especially can become mired down and derailed by a too-low enrollment rate. Read how using a patient network and identifying sites that best fit the needs of the trial can help overcome this challenge.
Discover how Almac helped one pharmaceutical company streamline processes and remove risk from their multiple clinical trial applications while maintaining data integrity with One Unified Clinical Trial Supply Solution.
Compromised data collection effectively stalled a clinical trial study of an inflammation control drug. With help from a CRO, important lessons were learned about the need for discipline and following protocol as well as the identification of Russia as a highly desirable site for clinical trials.
Premier Research was given a tight timeline of less than four months from delivery of the final protocol to first patient in. With proper site selection to accommodate the needs of a fast start-up along with open and frequent communication with the principle investigator and the project team, they were able to meet this timeline.
Late Phase Research in the Life Sciences segment is undergoing a rapid transformation due to the digitalisation of healthcare and the greater availability of, and access to, Real World Data (RWD). This transformation is arriving not a moment too soon, given the changes anticipated from the Twenty-first Century Cures Act, EMA’s Adaptive Pathways approach, and the increased demand for Real World Evidence (RWE) generated from these RWD. In addition to supporting regulatory decisions, RWE is playing an ever expanding role in developing the product value propositions that are driving reimbursement decisions globally.
Some sites have a lot of experience, and those are generally sought after, but they can be busy running other trials and may not prioritize yours. It may be beneficial to include less experienced sites in order to have better chances of enrolling. But of course, there are some necessary considerations when turning to these sites.
Learn how automating payments to research sites improves research site performance, supports site sustainability and delivers a more collaborative, trusting relationship between research stakeholders.
Trial design, site selection and recruitment, all tailored to the specific oncology indication. It’s what we do. Best.
Best-in-class processes coupled with industry-leading technology to fight for your trial’s success.
Biorasi builds partnerships with our sponsors. Your challenge is our challenge. We identify with your unique needs and leverage our systems, methodologies, and processes to design optimal solutions specifically for your trial.
Clinical trial management and late stage research to achieve regulatory approval and optimize product commercialization