Celerion to Present at Upcoming Veeva Summit
Celerion, a leading clinical research organization (CRO) provider to the biopharmaceutical industry, will deliver a key address on the final day of the Veeva R&D and Quality Summit, being held online October 13-14, 2020. The annual event brings together pharmaceutical, biotech and medical device & diagnostics leaders to discuss the latest innovations in the industry.
Julie Saathoff, Celerion’s Executive Director, will offer insights on how to Automate Information Sharing in Clinical Trials, examining critical drivers for change and the potential to improve manual document exchange and collaboration from study start-up to close-out.
Her presentation will be on Wednesday, October 14th at 11:45 AM (EST).
The presentation will demonstrate the utilization of the Veeva Vault Site Connect application for the data flow connection between remote clinical trial sites and trial master files. The application’s compliant electronic Internal Site File (eISF) allows electronic filing and remote monitoring of site-level source documents.
Celerion is one of the automated information-sharing platform’s early adopters, currently utilizing the technology for remote monitoring at their Early Clinical Research facilities.
Saathoff notes that key processes such as feasibility, study document exchange, safety and study subject status can be more easily stored and transferred electronically, for faster study execution in a validated manner. Additionally, the Vault Site Connect option adds a real-time aspect to compliance enforcement via documentation and project-specific team study training.
“The use of this technology eliminates the redundancy of multiple portals, manual transfers and the many ‘touches’ required when sharing data with sponsors during clinical trials,” she adds. “The resulting boost to productivity benefits patients and clients by measurably increasing efficiency and reducing cost.”
Virtual trial operations are becoming a reality during the race towards therapies. Celerion’s Vice-President of Global Clinical Development, Dr. Zori Cheshmedzhieva, shares how Vault Site Connect contributes to the virtual trial space:
“This technology moves the industry toward a single source for sponsors, sites and subjects to allow for rapid data access. The real-time analytics enable adaptive decision-making across both sponsors and CRO operational teams simultaneously.”
Dr. Cheshmedzhieva adds that Celerion’s Global Clinical Development group will utilize Site Connect to enhance its capabilities in implementing risk management and project activities as part of the greater effort towards virtual project delivery.
“This can be especially useful in the middle of a singular pandemic, when efficient, multi-site trial management can deliver a better experience for clinical trial volunteers,” she says.
A recognized global leader in early clinical research services, Celerion “translates science into medicine” through scientific excellence, medical expertise and broad clinical operations experience.
For fifty years, Celerion has been providing industry leadership in the execution of early clinical research studies in highly controlled clinical environments such as first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function.
Celerion’s Global Clinical Development team identifies challenges in the earliest stages of development and are well prepared to take your study to its full potential. Whether they are difficult to recruit trials in rare or orphan indications, multi-arm or adaptive design trials with sophisticated IMP setup, complex logistic, or trials with heavy recruitment competition, we have the ability to deliver robust and reliable results.
Celerion enhances this with superior data management, biostatistics, clinical monitoring and bioanalytical services. Our enduring mission is to help clients get their drugs to market in a timely fashion that benefits people in need the world over.