CLINICAL OPERATIONS
OPTIMAL STUDY EXECUTION THROUGH OPERATIONAL EXCELLENCE
Planning and executing clinical trials with high degree of excellence is vital to ensure R&D´s cost-effectiveness and to provide patients with health innovation in a timely fashion. Yet, many companies struggle to find ways to make it happen in a consistency manner.
Our Clinical Operations services are underpinned by technological solutions and agile processes so that we can leverage your potential to deliver high quality health innovation as if we were an extension of your team.
RISK-BASED STUDY EXECUTION
Identify which patients and sites have atypical data patterns that lead to the discovery of operational issues and optimize your CRA workforce capacity.
Higher Data Quality / Greater Resource Efficiency / Reduced Study timelines.
Our risk-based proactive approach to data quality and integrity can lead to a reduction of up to 40% in monitoring visits & source data verification.
FLEXIBLE PROJECT MANAGEMENT
Whether you need a permanent or a temporary solution to manage your clinical trials across different therapeutic areas and regions, we are here to support you.
With risk-based thinking embeded into our ways of working, meaningful project metrics/specification limits and balanced workload, our CPMs deliver high quality output through thorough project planning and execution.
CRO/VENDOR OVERSIGHT
Do you have outsourced studies and would like to ensure the best return on investment through data integrity, adherence to timelines and compliance with the project´s scope of work?
With our oversight solutions you will have an independent party looking after the important aspects of activities performed by your vendors and identifying trends that can be detrimental in the long run if not acted upon, so that you and your team can focus on strategic decisions.
MOBILE NURSES
With ever increasing costs in clinical trials execution, each piece of data must be looked after with the highest degree of attention.
Our mobile nursing services are a truly patient-centric solution to increase protocol compliance, patient retention and data integrity, while providing a better experience for clinical trial subjects.
e-TMF/e-ISF
To this date, inspection findings related to trial master files are still on the top of the list and, it certain cases, such lack of compliance may lead to applications being rejected by health authorities.
CLINERGY´s e-TMF/e-ISF solutions allow all stakeholders involved in your studies to create, approve and manage documents seamlessly through an easy to use CFR 21 p.11 validated system.
STUDY EXECUTION
At CLINERGY we pride ourselves on offering a trully client-centric approach. We can help you conducting your trial by providing operational excellence according to your needs:
- Study Monitoring
- Clinical Trial Applications
- IMP Importation and Management
- Medical Monitoring
