Many are also life sciences professionals who know the operating environment, the constraints and the possibilities, and they understand the background to successful science.
The following projects demonstrate the range of our experience in supporting lab-based organisations.
For more information or a discussion about a project, please do not hesitate to contact us.
Contact usLeading and resourcing multiple projects including: IS strategy, data aggregation/data-mining, trials management, systems upgrades and ongoing development, clinical systems – statistical system – LIMS interfacing and various validation projects.
Responsible for the services teams from the informatics suppliers delivering each of the products to create a single, cohesive solution. Under our direction, we structured the system to enable ‘management by exception’, removing transcriptions, and manual verification steps on ‘inspect results’ and using integrated instrumental workflows.
Deliver a ‘seamless’ workflow to encompass sample management, laboratory planning, test execution and results review. We managed the project scope through two phases with both clinical supplies and product development groups.
Maintain a high user satisfaction level while successfully balancing ongoing change requests and day to day support calls within a fixed monthly budget.
Implement a robust and effective LIMS with a short and immovable deadline. Providing 24hr onsite support for the duration of the sporting event.
Manage the design and implementation of a system to one site in China with plans to roll out globally.
The project began with a training course to lab employees referencing lims management requirements and ISO17025, leaving them with a sound appreciation of how it relates to the lab and how it impacts lab systems management. But the outcome was an immediate the need for a QMS update.
We provided a gap analysis of the existing quality management system to the ISO standard, referencing the management requirements and identifying amendments to the system. We updated all docs and delivered an updated QMS.
We provide that support from a strategic standpoint including system design and SOPs, and robust testing procedures all the way through to roll out. We also provide resources to support studies, including technical issues with the software and the platform that go well beyond vendor help desk responses.
There are often multiple vendors involved in an ePRO project and could be several studies going on with different stakeholders. In such situations, it helps to have someone on the team with an overview of the whole programme, both highly technical and with a commercial outlook.
The following projects demonstrate the range of our experience in supporting organisations conducting clinical trials.
For more information or a discussion about a project, please do not hesitate to contact us.
Contact usDevelop an ePRO strategy to move from paper based clinical trial diaries to e-diaries. The project entailed organisational change management, impacting all levels throughout the design, planning and execution and data management of clinical trials. We were responsible for securing senior stakeholder buy in, selecting long term vendor partners in a rapidly changing software environment, technology selection and embedding the platform for future trial projects.
Study specific requirements definition and validation of e-PRO system. We helped to create a replicable approach to clinical studies e-PRO implementation, translating protocol design and study team requirements into vendor facing technical requirements. We also undertook design and execution for rigorous user acceptance testing scripts.
Develop an ECRF upgrade business case and project plan. Managing the technical upgrade and software vendor engagement, ensuing SOPs and work instructions and training to reflect the new system. We also designed the validation model, created and executed performance qualification scripts.
