The Challenge

Increasing the efficiency of project turnaround times is a major challenge for pharmaceutical companies and Contract Research Organisations alike. Within these controlled, regulated environments the goal to reduce project completion times must never compromise rigorous study planning, the integrity of data management and accurate study reporting.

For bioanalytical studies report generation is a time-consuming, labour-intensive exercise. In contrast to the largely automated analytical ‘upstream’ processes, report generation often requires a great deal of manual intervention resulting in a pinch-point for project completion. Often data input is required from a number of laboratory computerised systems including LIMs, CRMs and ELNs. The resulting report therefore needs to be checked and then rechecked for accuracy before final QA approval and report submission. Similarly study plans, which may need to incorporate a number of bioanalytical methods, sponsor information and analyst training records often require lengthy validation and cross-checking before sign off.

Automating production of study plans and reports via validated data transfer from data management systems into custom built templates will eliminate transcription and data transfer errors, save time, cut costs and lets scientists concentrate on what they do best – the science itself.

Terrington Data Management, working in close collaboration with a major bioanalytical Contract Research Organisation, has risen to this challenge and has developed a new software product – OPAL – a study plan and report generating tool for use in regulated bioanalytical laboratories.

The Solution

OPAL (Open Project and LIMs) streamlines study plan and report generation. OPAL integrates core laboratory data from your LIMs (e.g. Thermo Fisher Watson^TM LIMs) and other supporting systems (e.g. ELN, CRM) into secure, pre-validated custom templates. OPAL automatically generates plans and reports without the need for lengthy checking procedures.

From OPAL’s main menu the user can prepare:

• Study Plans (using bioanalytical validation, clinical and phase design templates)
• Report Tables (automatically generated – with data taken directly from Watson^TM  )
• Study reports (with data imported from the report tables in to predefined templates)

Report tables can incorporate data from single or multiple analyte studies and the user can select the tests to be performed on the data. For complex validation studies these can include multiple tests (e.g. ISR, Calibration parameters & standards, QC’s, Matrix effects, selectivity etc.) by contrast sample analysis may only require a single test to be selected. Whatever the study, tables are generated automatically via validated data transfer into secure MS Word documents.

The Benefits

OPAL saves time without compromising quality and data integrity. For a typical multi-analyte validation study, which tend to have huge numbers of tables, the time taken for checking and cross- checking is reduced by 80% (from 2 ½ days to ½ day)*.

In addition to time savings OPAL also offers:

• Secure login via Active Directory
• Incorporation of large and small molecule studies
• Customisable templates for both Study Plans and Final Reports
• Configurable Watson reports
• Import data from ELN and CRM (any computerised system using Oracle or SQL Server database)
• Export to read only or editable MS Word or Excel documents
• ‘Sneak Peak’ function allows the user to check how the study is progressing
• Terrington developers on-hand to incorporate your exact requirements

For more information please complete the enquiry form on the CONTACT US page. We look forward to hearing from you

*Case Study to follow