Pragmatic clinical trial database advice and provision
Our clinical trials information systems(IS) expert is retired from full-time employment giving her time to Aligns.
No surprises - fulfil your clinical trial expectations with expert individual expertise at Aligns - get trials up and running!
What do we offer?
The integrity of clinical trial data begins with the system(s) that collect & protect it.
We can provide advice on information systems and data governance for Clinical Trials Units, Chief Investigators, and Sponsors, both academic and commercial, including SMEs that don’t have a data management department but require compliant data to move forward with their product, at a reasonable cost. In addition, we can work with you to develop a clinical trial database that is in adherence with your clinical trial protocol and facilitate choosing which electronic data capture meets your needs.
The systems that hold clinical trial data carry more weight than ever.
The use of direct data capture from electronic patient-reported outcomes (ePRO) and other sources such as wearables, use of NHS routine data, means that clinical trial data is increasing in complexity. This makes clinical data management (CDM) critical to efficiently consolidating these disparate data sources into one centralised place while maintaining data integrity and quality.
Computerised Systems Validation (CSV)
We offer a range of specialized services tailored to meet your individual needs.
Provision of Regulatory advice
We offer a range of specialized services tailored to meet your individual needs.
Who?
Sharon Kean is an experienced triallist. With over 35 years of experience in clinical trials, using that expertise, can produce key essential clinical trials documents or act as an independent reviewer within her areas of expertise. Sharon’s career has encompassed overall responsibility for clinical trials IT infrastructure, software developments, IS systems management, data security, and the required data management and data integrity capabilities/compliance that underpins the conduct of clinical trials and observational studies within a clinical trials unit setting.
Sharon has made a significant contribution to building IS operational and technical capacity at one of the UK’s most productive trials units, in her role at Robertson Centre for Biostatistics, within the Glasgow Clinical Trials Unit. Her leadership has supported the delivery of landmark trials across cardiovascular medicine, diabetes, neurosciences, and rehabilitation — including WOSCOPS, DiRECT, ALL-HEART, SCOT and FAST— ensuring that the data systems and processes underpinning these studies meet the requirements of quality and regulatory compliance.
Sharon’s contribution to the wider UK clinical trials community was extended through her active engagement with the UKCRC Registered Clinical Trials Unit Network whilst working in Glasgow. She has played a central role in the Network’s Information Systems Operational Group, which brings together IS leads from registered CTUs across the UK to develop shared standards, tools, and guidance for the conduct of clinical trials. Her work within this group contributed to a landmark piece of methodology research, published in Clinical Trials, developing a risk-proportionate approach to the validation of statistical programming — a project embedded within both the Information Systems Operational Group and the Statistics Operational Group of the UKCRC Registered CTU Network. This guidance addressed a significant gap in practice, providing CTUs with a practical framework for ensuring the scientific integrity and reproducibility of statistical programmes in a resource-efficient way.
Sharon’s national profile is further evidenced by her affiliation with the Liverpool Clinical Trials Centre (LCTC)at the University of Liverpool, a leading UK clinical trials unit and methodological research group with full UKCRC registration,. Sharon worked at LCTC for 3 years and contributed to methodological research on the design and delivery of clinical trials, and has presented on behalf of Health Data Research UK at national trials methodology forums, including the Trials Methodology Research Partnership (TMRP).
Sharon has presented her work at leading international clinical trials conferences, including the International Clinical Trials Methodology Conference (ICTMC) and the Society for Clinical Trials (SCT) Annual Meeting. Her presentations have addressed information systems, data management, and technology innovation in the context of trial conduct.
