Study Asset Migration Planning

The BioPharma industry is often in a state of transition with regards its clinical data landscape. This is due to mergers, acquisitions, and upgrading to new computer systems. Clinical Study Data stored on one platform often needs to be migrated in a one-off exercise to a new computer system.

 

There can be many studies (circa in the thousands) and the migration effort can spread over several weeks if not months. The migration process is not a simple backup from one system and restore to another.

 

This is because many of the studies are still on-going and can be active for several years. Migrating historical studies can be less of an issue, but active studies need careful management to ensure that data is not duplicated on both systems, or worse still missed from the target system.

 

Data Migration Projects

Many clinical research organizations are looking to migrate their current and legacy clinical and related operational data from proprietary software databases into enterprise data lakes, to enable a more data science-led approach to their R&D.

 

This can be a huge undertaking, which requires the whole organization to be onboard. Current, transition and future state planning is essential, including all stakeholders, alongside detailed technology expertise of legacy systems and on-prem/off-prem data lake solutions.

 

Achieve Intelligence have a wealth of experience bridging business and IT capabilities and can help you plan, manage and execute a successful delivery of your migration exercise to ensure your organization can leverage the benefits of a data science strategy.

KPI Metrics

Measuring key performance indicators for multiple studies, of differing phases, across all types of therapeutic area has been a challenge for many years in the BioPharma sector.

 

Inconsistency and inaccuracies have caused false positive readings leading executives and sponsors to panic when there was no need, and worse, false negative readings leading to costly trial conduct violations which should have been avoided through an accurate early warning KPI system.

 

Achieve Intelligence have developed methodology to consistently identify critical data points, within a landscape of multiple attributes, providing executives with a dashboard of actionable metrics; ensuring smooth operations & efficiency identification, across all types of clinical studies.

Tool Reviews

There are thousands of software products, offering similar benefits to the BioPharma industry, and though diversity can enable off-the-shelf requirements-fit, huge effort can be expended reviewing which capabilities are offered by which tool.

 

Best practice and regulations have identified that organizations need to audit how software is chosen, through RFP procedures – however companies should be able to realize additional benefits from these processes, without it turning into a tick-box exercise.

 

Achieve Intelligence have developed a method which identifies hundreds of products in the clinical data management space, categorizing their features and functions; to help companies fast-track their decisions during the long-list/short-list stages of the RFP process, within GCxP guidelines.