Consulting > Clinical Technology
Service Overview
Our team has unrivalled experience of working both with sponsors and vendors on a wide variety of technology issues and applications relating to management of clinical trials. This experience covers the spectrum of activities from pre-clinical through to phase IV clinical trials. Our consultants are fully conversant with the regulatory requirements of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and how to integrate smart use of technology to help meet these requirements. GxP Consulting provides both biopharma sponsors and technology vendors with unrivalled e-clinical expertise across EDC, ePRO, IVR / IWRS / IWR (IXRS), CTMS, eCTD, document management and other technology solutions in order to help deliver your clinical studies.
For sponsors GxP Consulting offers your business a “vendor neutral” view of the world – being able to advice on the most appropriate technology from the most appropriate vendor. For CROs and other service and technology providers, GxP Consulting offers a skill set and experience base that can help you achieve your business objectives and compliance requirements.
The Need
e-Clinical technology is now an accepted part of the clinical development landscape. Many applications and many vendors.
In a crowded space how do you make the right choices for your business?
- Decide on the right technologies to use
- How do they fit together
- How do you select the most appropriate vendor
- How do you manage the process from specification, through implications to project closure?
Strategic Consulting
With the collective experience of successfully delivering hundreds of clinical studies, our team is ideally placed to help you address the challenges and questions that must be addressed, including:
- Which systems and technologies should be used to best serve the needs of the clinical study and the business?
- If multiple systems are to be used, how should they integrate?
- How should these technologies be managed?
- Management of vendor selection processes and subsequent management of vendors
- Organisational and management structures to ensure you get the best from the technology within the business
Tactical services
- Specification management for application eg IVRS
- Implementation of e-clinical applications
- e-Clinical testing and validation support (IVR / IVRS / IWR, eCTD etc.)
- Project management of new technology implementation and of vendors
- Crisis support – when things are going wrong what do you do?
- Specifying job roles and functions needed to manage and implement technology
- Recruitment support including job specifications, personnel specifications and interviewing and appointment
- Training and knowledge transfer in understanding and use of e-clinical technology
