From reporting challenges to data integration and data silos with clinical data management, to the continuing search for greater automation, clinical operations and contract research organizations (CROs) face mounting challenges. The squeeze on the bottom line means they must do all of this – and more – with fewer resources.
Crucially, clinical trials require closer collaboration between many different functions and all too often this results in deploying a wide range of systems that aren’t integrated, making seamless data sharing extremely difficult. Clinical is then forced into a difficult situation – working across several vendors that either can’t or won’t collaborate. This results in an all-too-common problem: vendor fatigue.
The need for an integrated, end-to-end approach to managing all aspects of a clinical trial, including all clinical database software, is pressing.
A Matter of Pacing
For many companies, addressing the issue of poor integration and data silos can be attributed to resource constraints. Unfortunately, many companies respond very slowly to the traditional issues that plague the industry, never mind current and future developments, such as mobility, an increase in data from sources such as wearables, automation and, increasingly, machine learning.
There are multiple reasons for this, be it cost-related, concerns over how a solution will integrate with existing software and infrastructure, compliance restraints, and uncertainty in global markets.
To counter these barriers, companies need a versatile multi-tenant cloud-based solution, that enables a single source of truth for greater efficiency and improved data quality, and is fully configurable to reduce the cost of conducting clinical trials.
An end-to-end solution is important not only to reduce vendor fatigue but also to enable IT departments to better support their business counterparts. A common technology stack enables efficient, scalable and seamless data integration across systems used by other functions.
Furthermore, the fact that clinical trials are increasingly global can add to data challenges. Having a complete cloud-based clinical trial management system makes it easy to manage data centrally and thereby achieve costs savings and improved access to data.
Consider study set-up, including activities such as randomization and trial supply management (RTSM), investigator selection, and document distribution and site visit planning. Automating these activities helps to significantly improve productivity as well as quality.
Another challenge that clinical battles with is the high cost and disruption of updates, whereas multi-tenant cloud-based architecture removes those barriers through rapid innovation and seamless updates, helping companies to enhance total cost of ownership.
ArisGlobal believes a clinical trials solution should enable cross-functional effectiveness, scalability and flexibility to facilitate integration and collaboration with partners, and out-of-the-box capabilities with the lowest risk through pre-validated industry standard practices. Our LifeSphere® Clinical adopts a TCO approach to tackling the multiple challenges that clinical operations departments and CROs face.