'Arkivum offered the best package for the solution we are looking for. Their team was knowledgeable, very helpful and responsive from beginning to end. We are looking forward to working with the team for subsequent eTMF archiving needs.'
Celia Baula Head of Quality and Director, R&D Program and Portfolio Management, Neuraly
As two of Neuraly’s clinical studies are currently in Phase II (with three more in pre-clinical stages), the Quality function within the business sought to establish a Quality Management System (QMS). Part of this process included the outsourcing of the archival of the electronic trial master file (eTMF). The storage of the eTMF within the archive must be compliant with the requirements set by Good Clinical Practice (GCP).
Neuraly chose Arkivum’s solution because they needed a reliable provider who could help them meet regulatory requirements and compliance in storing their eTMFs offsite.
Arkivum worked with Neuraly to identify and define the requirements needed from an eTMF to ensure they were compliant with GCP standards, FDA regulations and in alignment with ALCOA+ principles.
'Cerevel felt that the Arkivum solution’s capabilities went beyond what their current organisational needs were but that they would be a partner who would be able to meet their preservation requirements not only now, but in the future.'
Currently, they have three ongoing Phase 3 trials and an open-label extension trial for Tavapadon in Parkinson's, two ongoing Phase 2 trials and an open-label extension trial for Emraclidine in schizophrenia and an ongoing Phase 2 proof-of-concept trial and an open-label extension trial for Darigabat in focal epilepsy.
These trials have and will continue to produce high volumes of valuable digital records and data. A large proportion of these records and data are managed through Veeva, their live electronic Trial Master File (eTMF) solution. While this system is an effective solution for the management of the live trial data, Cerevel is aware of the limitations of using this system for the archival of their records.
Cerevel felt that the Arkivum solution’s capabilities went beyond what their current organisational needs were but that they would be a partner who would be able to meet their preservation requirements not only now, but in the future.
'Not having an approved digital archive meant we couldn’t accept them [digital research records]; we were unable to provide a full service and didn’t have any oversight of the digital records. This created problems for research staff and sponsors and was logged as a high-scoring risk at Trust level.'
Sandra Blake
Corporate Records Manager for Barts Health NHS Trust
Barts Health NHS Trust, recognized for its significant research initiatives, encountered difficulties with storing paper-based records. As demands grew for digital record acceptance and with no long-term digital archive in place, the Trust's capacity to deliver comprehensive services became compromised, raising significant risks. To address this issue, the Trust adopted a risk-based approach and procured Arkivum's system, enabling the acceptance of hybrid transfer requests encompassing both paper and digital records. This strategic investment not only mitigated risks but also ensured compliance with long-term storage standards, enhancing stakeholder confidence in the Trust's commitment to research data preservation.