-
Clinical research is the indispensable method for determining the safety and efficacy of new treatments for human diseases and conditions. As crucial as dedicated biologists and chemists, medical professionals, clinical operations experts, data managers, and biostatisticians are to successful research, realization would be impossible without the participation of patients and their caregivers. Yet many potential participants, despite their willingness to engage in research, have faced some inhibiting barriers. For many years now, the industry has made progress in easing patient and caregiver burden through ever-advancing technologies. The advent of practical artificial intelligence (AI) tools is another step forward in making clinical research comfortable and attractive to patients.
-
The importance of keeping an inspection-ready electronic trial master file (eTMF) at all times cannot be understated; the TMF tells the story of the clinical trial and should serve as the ultimate source of truth for the study. An inspection-ready TMF is complete without being redundant and efficient while still upholding high standards of quality. This might sound like a lot of work, but don’t let it intimidate you; an inspection-ready TMF can be achieved by following the steps outlined below.
-
PROMETRIKA was one of the proud sponsors of the MassBio Rare Disease Day Forum in Boston. Several of PROMETRIKA’s team members from Clinical Operations, Biostatistics, and Project Management came away from the event with new insights and increased dedication to contributing in the rare disease space.
THOUGHT LEADERSHIP
