Unlike other industries, Life Sciences Industry has been utilizing several different IT systems for it’s unique needs. To meet strict regulatory and compliance requirements it is necessary to maintain subsets of data and information related to clinical trials in separate systems. This leads to inevitable data duplication resulting in reconciliation efforts across systems. There had been efforts over the years to integrate various clinical IT systems to eliminate reconciliation efforts and have single source of truth for the clinical trial data. It had always been challenging to ensure interoperability between systems built on different legacy technologies. Movement of some of the legacy systems to cloud made it even more difficult.
A native Veeva Life Sciences Industry Cloud Platform was spot-on. Starting with eTMF, Veeva became first of its kind, user friendly, fast, and simplified solution. After gaining huge traction in TMF space, maintaining same philosophy of keeping things simple and fast, Veeva went on adding different solutions to the cloud platform. With the use of advanced technology, solutions were designed to cater different clinical trial needs maintaining similar system architecture and user interface. This made it possible for Veeva to achieve interoperability between their system. eTMF and CTMS put together known as Clinical Vault proved how efficient things can become when native cloud system is build keeping interoperability in mind. The next game changer would be Veeva CTMS to CDMS integration which would leading to efficiencies the industry has not witnessed before. Country, Sites, Site User’s information can be synced to CDMS from CTMS whereas Subjects Status, Visits information can be sent over to CTMS from CDMS. Programmable protocol deviation generated in CDMS can be synced to CTMS and a combined list of manual and programmed PDs can be made available in CTMS. This has not only helped gain efficiency by reducing data redundancy but also ensured seamless data flow across systems. Furthermore, solutions like Study/Site Start Up(SSU), Site Payments, SiteVault being available on same platform makes it really unified.
As industry is seeing wide adoption of decentralization and digitization Veeva’s Clinical Data suite roadmap looks aligned with futuristic needs. With three planned major releases a year, with some exciting features, purely based on customer feedback Veeva is able make their products evolve by codeveloping them with their customers. The evolution of Veeva CDB over a very short period of time is astonishing. Industry had to wait quite a long to see a simplified workbench getting developed where we can aggregate data from multiple sources, review/reconcile and transform data. We have seen efficiencies in building databases with Veeva CDMS and the day is not far in the future when we will see significant improvements in database lock timelines with effective use of CDB which comes with features such as bulk querying, bulk freezing, bulk locking, and snapshots. It would be no surprise if Veeva’s new offering RTSM, ePRO and eConsent could also ensure similar evolution with interoperability with other solutions with same simplicity and speed.
In addition to unified platform, for the effective setup, conduct and closeout of Clinical Trials, a hardened business process is a must. Sponsors and CROs would have to evolve their SOPs to embrace the system advancements. There must be strong mechanisms in place to implement new features released every quarter ensuring impact assessments. The system and process evolution has to go hand in hand to reap the benefits. CROs should make best use of advantage they would have with experience of implementing systems and processes for several sponsors and wider therapeutic areas. Partnering with Veeva, CROs would be in best position to bring agility to overall clinical trial processes and harmonize data flow across systems.
To cater increasing data volume and velocity, expectations to adopt to platform, umbrella and basket trial designs, patient centricity, regulatory requirements such as diversity of patient population, a combination of robust business process and unified platform is absolute need of the hour. A services partner with experience of adoption can help drive the change management with systems, business process and people. A phased approach of adoption would be effective in minimizing risks of downtimes, disruptions etc. Handholding of early adopter teams by system & process experts could ease the transition.
