A successful clinical transformation requires a thorough understanding of people, processes and use of technology within an increasingly complex regulatory landscape. Every organization’s transformational journey differs – from breaking down siloes, standardizing and consolidating data and content and optimizing your business – NNIT provides the services needed to support you every step of the way.
What is Clinical Transformation?
During the past decade, Clinical has undergone significant changes. Technology has evolved, yet with increasing requirements from authorities the challenge is to maintain legacy systems which today are complex and costly. Many Clinical departments have a desire to transform their business through new technology, and to reap the benefits of innovation and IT optimization. The challenge is how this is governed, defining the roadmap for transformation and securing its long-term success.
The Technology Enabled Clinical Trial
Clinical Trials today, requires a multitude of systems supporting the clinical trial conduct - some manual and some electronic, with data and content in many instances managed in separate, fragmented and non-integrated IT applications, such as Electronic Document Management System (EDMS), Electronic TMF (eTMF), Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Statistical Computer Environment (SCE) etc.
While these IT solutions supports our individual clinical trial activities, the data and content generated and managed in these are typically siloed, hindering end-to-end process optimization, efficient collaboration and oversight while requiring significant workarounds and at times resource heavy manual data entry and duplication between systems.
The Clinical Transformation starts with a unified platform, enabling seamless data and content management, standardize data models and use cases, improving both compliance and operational efficiency.
Data Driven and Informed
Silos inhibit the access and use of data and ultimately results in unrealized potential in use and re-use of information. Clinical transformation looks beyond the individual clinical trial conduct and introduce the use of new technology to help us better identify risks and success rate early in the study design phase and through study start-up.