Project experience

Find out how we’re helping scientists worldwide

For a small consultancy we have a pretty big impact, working with top tier, global pharma and vaccines companies as well as smaller lab-based organisations around the world. Client confidentiality is critical to life sciences so naturally we cannot present detailed stories, but the following outlines should provide an idea of the range and depth of work we are involved in.

Scimcon’s people are different from IT consultants because they all have lab experience.

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 us
The digital lab
Long term partnership (2004-present) leading significant IS projects
Customer: Top 5 vaccines development in USA and Europe
Roles: Project leads and technical specialists

Leading 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.

The digital lab
Implementation project for LIMS, test execution and CDS across six sites, Europe and USA
Customer: Top 5 Global pharma
Roles: Project lead, Chromatography Data System (CDS) Specialist

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.

The digital lab
Replace in-house LIMS and integrate with Electronic Lab Notebook
Customer: Top 10 Global pharma in USA
Roles: Project leads (two consultants) and Electronic Lab Notebook (ELN) specialistists

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.

The digital lab
LIMS upgrade, ongoing change control and validation services
Customer: World leading drug surveillance laboratories
Roles: Technical Specialists & Remote Systems Admin

Maintain a high user satisfaction level while successfully balancing ongoing change requests and day to day support calls within a fixed monthly budget.

The digital lab
LIMS implementation
Customer: Drug surveillance for world class sporting event in the UK
Roles: Technical specialists and onsite systems administration

Implement a robust and effective LIMS with a short and immovable deadline. Providing 24hr onsite support for the duration of the sporting event.

The digital lab
LIMS implementation (including formulation, batch production records and inventory management
Customer: Top 5 Global FMCG
Roles: Project Lead and Business Analysis

Manage the design and implementation of a system to one site in China with plans to roll out globally.

The digital lab
Quality management system updating, and training for lab systems
Customer: National Gas Utility Co, Major ME production site
Roles: Project Lead and Business Analysis

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.

Companies involved in clinical trials need advisers who can interface with a vendor to define the requirements of the system, and provide support in the implementation and validation.

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 us
Clinical trials electronic systems
ePRO strategy and vendor selection / initial roll out
Customer: Top 5 vaccine company
Roles: Project Lead and Business Analysis, Technical Specialists

Develop 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.

Clinical trials electronic systems
ePRO management and roll out of ongoing studies
Customer: Top 5 vaccine company
Roles: Validation Leads

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.

Clinical trials electronic systems
Electronic case report forms (ECRF) major system upgrade
Customer: Top 5 vaccine and pharma company
Roles: Validation Leads

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.

For more information, please contact one of the Scimcon team today

+44 (1638) 661 631

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