Despite years of efforts, drug development continues to be challenging, complex, costintensive and time-consuming. The pharma R&D process requires years of research and huge data gathering. Through the whole process from discovery and development to clinical trial, a drug developer would have gathered massive data on compounds, diseases, patient information, test results, experimentation results, formula, dosage, and FDA compliance requirements. This data is kept in separate databases and it makes it challenging for pharmaceutical companies to utilise vast quantities of data.
Integration of the data collected from several internal functions and external partners is necessary to create a complete picture for the key stakeholders. With more players involved in the R&D process, pharmaceutical companies have to manage data sets coming from a larger number of databases.
Integrating and controlling clinical data at one place, a so called hub, can help life sciences organisations in making informed decisions based on more accurate and timely information. The hub collects clinical and non-clinical data from multiple sources into a single environment to analyse and report that supports informed decision-making and regulatory submissions.
With the growing need for adoption of digital technologies, companies have changed their approach by incorporating valuable insights from multiple sources of data, radically improving patient experience, enhancing clinical trial productivity, and increasing the amount and quality of data collected in trials. Different Electronic Data Capture (EDC) systems with its own portal, own system, own adverse-event reporting have been reducing the complexity in managing clinical data. The global EDC systems market is expected to reach US$ 1.16 billion by 2025, according to a new study by Grand View Research, Inc. The process of assessment of data and uncovering the patterns which are hidden in it is solved by big data analytics. Big data analytics also helps in maintaining drug efficiency and safety for regulators and pharmaceutical companies. According to MarketsandMarkets, the global life science analytics market is expected to reach US$24.73 billion by 2021 from US$ 13.26 billion in 2016.Using analytics to improve the efficiency of clinical trials by utilising data would be a great gain for pharmaceutical companies.
However, security risks are even higher in these cases as data is shared among multiple stakeholders. Access to confidential information such as a patient’s Personal Health Information (PHI) from clinical testing or health histories increases the risks of critical information getting compromised as there are a greater number of data transfers and sharing. Life sciences organisations have to be compliant and responsive to regulatory requests.
Use of standards to facilitate increased R&D efficiency, while ensuring regulatory compliance with comprehensive security, an audit trail, and traceability is the key for the providers of EDC systems. There is a lack of data standards to monitor and regulate master data for data-sharing among multiple EDC systems, between EHR and EDC, and among stakeholders. This remains an inherent challenge for pharmaceutical companies.
In the cover story, Suresh Selvarangan of Navitas Life Sciences explains the role of data integration and analytics and how it helps in faster decision making and clinical trials.