Utilising expertise and experience to deliver the best selection, integration and use of e-clinical technology solutions for your business.
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. GxPi 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 GxPi 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, GxPi offers a skill set and experience base that can help you achieve your business objectives and compliance requirements.
GxPi are members of the drug information association (DIA) initiatives for:
• The EDM reference model
This is a document management initiative aimed at developing a taxonomy/metadata reference model that can ultimately be shared by biopharmaceutical organizations as a common starting point for building sustainable, shareable EDM repositories.
• The electronic trial master file
This is a document management initiative aimed at developing a structure, taxonomy and content for building electronic Trial Master Files for submission.
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 maximise value from the e-Clinical technology within the business
• 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