In 2004, I started looking at the opportunities available for the training of pharmaceutical programmers, and have often felt that there should be a forum where people can get together to share ideas, thoughts, concerns and ask questions about the future direction of the industry. PhUSE providing the industry with the premier platform for creating and sharing ideas, tools, and standards around data, statistical and reporting technologies; PhUSE is a community of professionals who are passionate about advancement of clinical information.Share – Contribute - Advance

Member of the senior leadership team and responsible for leading the global business development, marketing, proposals and contracts teams as well as providing expert biometrics consultancy to our clients.

Co-founder of Cerafor, a specialist biometrics company, based in the UK. We provide bespoke biometrics services to help clients manage, analyse and report clinical trial data to global regulatory submission standards. Please visit our website to learn more about how Cerafor can help you: www.cerafor.com.As an Executive Director of Cerafor his responsibilities include provision of technical leadership, business operations and strategic business development.

To maximise the profitability of all sites, ensuring that staff & assets are best utilised, working closely with the Finance Director, Heads of Function & HR.Management of the company’s leases and insurance portfolio dealing with landlords and external providers and suppliers as required and control a continuous review of company property to ensure the best mix of cost, flexibility and adequacy of space is available to support the company staff strategy.To work with Heads of Function and HR to develop a staff retention programme.Ensuring all central support functions provide a timelessly and efficient service to all sites, whilst making sure that foreign subsidiaries maintain accurate HR, financial and legal records in line with local laws and the procedures and processes of the group.Complete reviews of upcoming work to look at staff utilisation via the tools that are available and run a monthly review meeting to control corporate costs, initiatives, and services.Responsible for maintaining current relationships and being the link-pin between operations staff and the customers.Investigated, sourced and implemented an electronic customer feedback web interface encompassing detailed live data analysis capabilities.Successfully managed complex relationships across all customers – especially those where there are a significant number of stakeholders and detailed matrix environments to navigate through.Point contact for receiving and reviewing customer feedback and subsequently investigating suggestions to then provide a continuous improvement strategy to operations.Launched the medical writing department from two individual writers to a functional, experienced team of 14 writers who are globally positioned to provide expert support and quality deliverables.Ensured both Medical Writing and Programming were compliant with all required procedures (both internal and external) and led a project to roll out a complete set of SOPs following an internal integration.

Established a fully functioning, highly motivated group of programmers and medical writers.Specified and implement a visual report to ensure corporate compliance to worldwide regulatory filing requirements.Achieved a decrease in both programming and medical writing cycle times as well as a reduction in the cost base without an overall lose of quality.Championed process change to allow clinical trial results to be analysed within 24 hours of data base lock.Took the lead in developing the future medium term strategy for the direction, the initiatives and the scope of a Global Function.Continued to lead the PhUSE conference and the committee to a second successful conference and set up a steering board to shape the future of programming knowledge sharing within Europe. Engineered, implemented and embedded a single set of global processes to enable load sharing and an effective use of service providers.

Managed a programming team through Phase II/III, submission and successful global approvals for an unmet medical need. Sensitively assisted with the closure of a European Office including the redeployment of several hundred clinical studies. Liaised with an external pharmaceutical company for a divested compound during the approval phase. Instrumental in the design and implementation of global standards and processes. Set up multi-million pound contracts with a new resource supplier. Built a global working relationship with another major site so that project work was load-shared effectively.Responsible for maintaining current relationships and being the link-pin between operations staff and the customers.Investigated, sourced and implemented an electronic customer feedback web interface encompassing detailed live data analysis capabilities.Point contact for receiving and reviewing customer feedback and subsequently investigating suggestions to then provide a continuous improvement strategy to operations.Led the programming component of a migraine program from Phase III through global submission and approval. Successfully worked with Japan in running and reporting a bridging study, together with the subsequent submission and approval. Provided subject matter expertise on the “end-game” of two further drug submissions. Organised and controlled the programming aspect of a successful MRP approval within Europe, whilst building strong links with the clinical, regulatory and statistics teams. Designed an “ongoing review of safety data” data presentation program across several drug projects.Extensive training to become an experienced SAS Programmer. Worked with a multi-functional team across Pfizer sites to redesign and code the way that laboratory results are analysed in clinical study reports. Led a team of ten junior programmers to re-map in excess of 100 studies for inclusion in two different submissions.