information systems

Service description

Information systems are critical to all stages of the development and commercialisation of new medicines. We aim to assist our clients deploy application systems to support various business driven initiatives, such as Time-to-Peak-Sales.

Our approach is to understand the business context of the proposed system, most importantly, what benefits it will. The detailed requirements need to be agreed by all stakeholders, in the form of a signed-off Statement of Requirements

The decision on the most effective development route depends on the balance of a number of factors, such as corporate attitude to build versus buy and whether suitable packaged applications or software toolsets exist in the marketplace. Our consultants adopt a rigorous approach to this major decision, with the evaluation leading to the most cost-effective development path being selected.

The outcome of the Development phase of the project will be a system that meets users requirements, as proved by a rigorous testing process. The key deliverable is a working system that has been accepted by the user community as meeting their needs.

The deployment phase is the moment when the delivered system impacts users in terms of changing the way they work and begins to deliver business benefit. A change management program is associated with the introduction of any business critical system to assist users make optimal use of the investment. The final deliverable, approximately six months after the system goes live, is a Post Implementation Review, which formally measures the value of the investment in terms of the cost-benefit relative to the original brief.

Case study

• The company is a multi-national biopharmaceutical company, headquartered in the US, with offices in all the main European markets.
• Clinical development teams working in US and Europe needed the capability to have online access to clinical data held in other offices in the form of paper Case Record Forms. Inability to review data promptly was identified by the team as a real impediment to conducting a co-ordinated international program with possible implications for registration timelines.
• An international team specified, selected and implemented a document management solution that made the entire clinical records archive available online to authorised team members on any site. The essential ingredient of the project's success was agreeing on a standardized approach on both sites, with a common technical architecture and consistent document indexing system
• From a user perspective the exact location of any particular file became irrelevant and team members could share data online. The document repository is also available to staff on remote sites, who save time compared to the previous practice of requesting faxed copies.