GxP Consulting, a leading provider of consulting services to the pharmaceutical, biopharmaceutical and healthcare industries, announces the expansion of its GCP compliance and clinical technology support portfolio to include statistical analysis support for clinical data assessment. GxP Consulting provides specialist knowledge and years of experience to offer cost-effective and time-critical off-site statistical and data processing services to the clinical trials industry. GxP Consulting also provides both clinical trial sponsors and technology vendors with e-clinical expertise across EDC, ePRO, IVR / IWR, CTMS, eCTD, document management and other technology solutions needed to manage clinical studies and improve data accuracy and integrity.
To accommodate the extended clinical technology support services and growing client base, GxP Consulting has also expanded its team of experts in this field. The new statistical analysis support service is led by newly appointed Timothy Haley, an experienced data analyst and SAS programmer.
Timothy has an impressive background in data analysis, with previous posts held at Novartis, Glaxo Group Research plc, Wyeth Research (UK) Ltd, European Commission and Serono. He has also lectured at a number of European Universities, conducting research and publishing literature on this topic, demonstrating his wealth of knowledge.
Mark Stevens, Managing Director at GxP Consulting, said: "It is an extremely exciting time for the clinical trials industry with the adoption of new technologies and the existence challenge of multiple vendors demanding the correct and efficient management of clinical studies. We are confident that our expanding clinical services portfolio and our growing team of experienced consultants will provide our clients with the necessary expertise to effectively manage the clinical trials process from specification all the way to project closure and eSubmission."
The comprehensive clinical technology support services offered by GxP also include assistance with strategic outsourcing decisions. This ensures products progress through the clinical trials pipeline as quickly and cost-effectively as possible. GxP practically advises on the systems and technologies to best serve the needs of the clinical study, the optimal method of managing technologies and how to efficiently integrate multiple systems. The consulting team also assists with the management of vendor selection and subsequent management of suppliers, as well as ensuring that organizational structures are implemented to gain the right results from deployed technology. Other services include assistance with expansion planning and training and mentoring services to help clients achieve business objectives.
The consulting division has already achieved results for several world-leading clinical technology organizations responsible for the management of several hundred drug trials around the world annually. By altering aspects of the company structure and suggesting modifications to business processes, GxP was able to generate significant time and cost savings in the product development cycles, whilst maintaining compliance standards. GxP Consulting provides high-value, results-focused regulatory compliance services to the highly regulated pharmaceutical and biopharmaceutical industries. This covers pre-clinical (Good Laboratory Practice), clinical (Good Clinical Practice), manufacturing (Good Manufacturing Practice) and wholesale storage and distribution (Good Distribution Practice) business areas.
GxP Consulting (gxpeu.com) provides businesses with high quality, results-focused regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GxP), qualified person (QP), quality assurance (QA), consulting, project management, validation, process engineering, computer systems, laboratory equipment, project management, design studies, training and clinical technology consulting services. Specializing within the Biotechnology, Pharmaceutical, Consumer Healthcare, Medical Devices and Veterinary industries, GxP Consulting provides a range of services to meet customer's needs.
For further press information please contact: Celine Callender, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom T: + 44 1477 539 539 F: +44 1477 539 540 E: gxp[.]scottpr.com