Apr 15, 2020
We will ensure that patient recruitment is delivered to plan. Our study management team is there to ensure your trial meets all regulatory requirements and effectively delivers a validated dataset as efficiently as possible.
Through the use of FARSITE we can offer greater capacity to carry out multi-centre trials by utilising GPs from a wide geographical footprint and provide access to patients that meet the required clinical trial protocol for quick and effective recruitment to your study.
Alongside our partners we work with you to manage trial delivery. Our unrivalled expertise and methodology in system and data validation, required for electronic health record (EHR) enabled trials, ensures the management of the study will remain data driven.
We will carry out all data management activities to ensure earliest possible database freeze and lock.
Our expertise in electronic health record (EHR) enabled clinical trials will provide you with close to real-time safety monitoring and reporting tools, allowing more comprehensive and accurate safety data to be collected. This new and innovative approach has the potential to set a "new gold standard” in safety reporting for clinical trials of the future.
ConneXon allows our patients to be closely monitored without intervention which helps maintain the ‘real world’ methodology, while maintaining patient safety and meeting regulatory requirements. This novel method of safety monitoring results in safety events being reported close to real-time, enabling safety signals to be detected more quickly than in a normal Randomised Controlled Trial (RCT).
We will provide interim datasets to meet your Independent Data Monitoring Committee (IDMC) requirements.
Here are some of the unique benefits of working with us during the trial delivery and data management phase of your trial;
· Reduced effort/cost for data entry and source data validation (SDV).
· Efficient and effective delivery from leveraging our existing relationships and network.
· More comprehensive and accurate safety data.
· Safer clinical trials.
· Close to real time and remote safety monitoring allows for a broader patient inclusion criteria and minimum intervention outside of normal care (more real world). monitoring.
We know more about our study patients than their doctors do. If someone is admitted to hospital we are automatically alerted and we can investigate and report within 24 hours.
Claire Williams – Clinical Safety & Quality Manager - NorthWest EHealth
Feasibility is the starting block for you to begin your clinical trial. We can help you by running complex and powerful searches over our depersonalized patient records.
We provide experts that enable you to design and mobilise a trial that allows you to gain the most value from the very start of the trial process.
Our team of experts will deliver your electronic health record enabled trial right from the initial stages we will be there to facilitate, support, and advise throughout.
Our validated technologies extract existing EHR data directly from source healthcare systems ready for transformation into clinical trial data that will be provided to you as a system independent data set formatted in accordance with your data requirements and Data Standards.
Through our unique relationship with the NHS and academic organisations we are able to provide a single point of contact for you to procure consultancy to help you both enhance your organisations capability and deliver your EHR enabled trial program.
NWEH is experienced in designing and delivering evaluation programmes for Complex Interventions. We can help you create the evidence needed to support the approval and sale of your Complex Intervention to the NHS.
For more information on how we can assist you with your trial please contact us.