Compliance in Clinical Research
Structured clinical data collection and management with Arxspan Electronic Lab Notebook
Clinical research is an expanding area of study, as academia, government, and industry seek to improve the success rate of clinical trials and the overall efficacy of new medicines, devices, and diagnostic tests. Efficient clinical data management is critical for compliance
At the bench research stage, scientists need standard electronic lab notebook functionality for recording their chemistry and biology experiments. As compounds progress to the animal testing stage, recording workflows for the handling of animals and materials becomes important. In sample processing laboratories, analysts need a more structured platform to ensure compliance with properly following procedures, accurately documenting results, and accurately tracking samples. Clinical researchers need an ELN to record and manage clinical data and observations and to manage documentation associated with various processes.
These diverse information management needs require an electronic lab notebook that is versatile and highly configurable to accommodate multiple and divergent workflows, yet robust and structured enough to maintain integrity and uniformity of processes. The Arxspan Electronic Lab Notebook has the flexibility to effectively manage recording of scientific and clinical data from its earliest stages at the bench all the way through to the clinical trials process.
Benefits For Clinical Research
Scientists have full ELN functionality to record discovery research and preclinical safety and metabolism data within Arxspan Electronic Lab Notebook. Custom workflows can be deployed to manage sample, animal, and material workflows. Patient questionnaires and approvals, sample protocols, test results, and project plans can be attached to experiments or other workflows. Arxspan Notebook has the capacity to store large data files, such as next-generation sequencing data.
The Arxspan platform is 100% cloud-based, fostering information sharing throughout the clinical research ecosystem’s network of sites, pharmaceutical companies, and academic research institutions. Biorepositories can be established and groups of patient samples can be linked to experiments for research and testing purposes. Arxspan Electronic Lab Notebook has decision support capability so that clinically relevant data can be sorted, speeding clinical decision making.
The system is 21 CFR Part 11 qualified and offers full experimental audit trails, digital signing and witnessing capability, and optional support for SAFE BioPharma signatures.