Requirement:

The client suspected that its UK planning and tracking system for clinical trial management was inadequate; the system was isolated from other systems resulting in duplication of effort and information, this led to inconsistent and unenthusiastic internal use. Azara Logic was invited to assess the business processes that impacted on the system and recommend any immediate improvements. Any changes would also require a help shifting internal user perception. After the initial analysis, Azara Logic presented recommendations on how to change business processes to achieve best practice and reduce duplication of information; these were accepted by the business. The requirement was then extended to three further world-wide sites with the objective of generating a set of global business processes for the company.

Azara Logic Process:

• Analysis

  Azara Logic needed to understand how people worked before any recommendations could be made. Azara Logic personnel talked with directors, management team, finance, clinicians, development operations, pharmacy, regulatory affairs and trial clinics to investigate their methods of working and business practices. Information flow, communication channels and data capture systems were identified. Azara Logic supplied comprehensive UML modelling diagrams and documentation to illustrate these methods. Areas of data entry duplication and lack of interdepartmental communication were highlighted. This initial process took 6 weeks and lead to the original recommendations. Project expansion then meant interviewing three further and separate sites in the States. These sites were of varying size and used very different practices but required the same amount of questioning. Based on the UK experience, Azara Logic put together a questionnaire, co-ordinated a military like schedule and flew to the USA. The interviewing work was completed successfully within a week.

• Project Management

  Azara Logic’s aim was to focus on the ultimate global goal not just the processes to get there. The four separate sites were historically, independent companies but after various mergers are now part of the whole brand. Autonomy at different sites was permitted but this in itself provided additional work to appreciate each company’s ‘ways’. Azara Logic had to maximise efficiency without influencing cultural and attitudinal differences. This started with selling the concept across the board and then setting up international telecom meetings to explain the new processes and to outline new team and division requirements. The ultimate aim was for one site to be able help another but this took tact, persuasion and diplomacy!

• Delivery

  Azara Logic developed new business processes and models. Where these affected existing systems, interfaces and the timing of data transfer between systems were defined. Areas of data input duplication were identified and changes proposed that would streamline the processes and reduce overall workload.

• Support

  Azara Logic was the only human element for the UK site and central coordination point for the worldwide project.

Success:

For the client, success was in the streamlining of the processes that saved time and money and the much-improved communication between companies and departments. For Azara Logic; the local idea was taken and implemented on a global level. In an environment were all global projects were being run from the US head office, Azara Logic was retained to project manage the global implementation.