Data Transformation in Global Pharmaceutical Research: Overcoming the Challenges of Managing 10+ TB of Daily Scientific Experiment Data for Clinical Researchers Worldwide

The Onset of Pharma 4.0, Precision Medicine, and Managing the Daily Surge of Data

At the onset of Pharma 4.0 and in the era of precision medicine, alongside continuous and innovative scientific clinical research, pharmaceutical companies worldwide are experiencing a massive 10+ TB daily flow of data. This exponential surge presents both significant opportunities and challenges. When managed effectively, companies can leverage modern technologies like IoT, automation, AI/ML, and big data analytics to accelerate drug development while ensuring patient safety, product quality, and regulatory compliance. However, failure to ensure data accuracy and consistency, mitigate security risks, integrate data from disparate sources, and manage vast amounts of information due to poor data governance frameworks and tools puts these companies at risk of falling behind in the highly competitive pharmaceutical industry.

The Business Impact of Poor Data Management in Clinical Research for Pharmaceutical Companies

Poor Data Management in clinical research operations can have significant impact on Pharmaceutical company’s global reputation, financial health, and their speed as well as efficiency of drug development. There are some of the prominent examples of businesses that have faced severe consequences upon their failure to manage data effectively in their research operations.

Ranbaxy, an Indian drug major was fined USD 500 million to settle criminal as well as civil charges about data integrity with the US Department of Justice. The company not only lost a few millions from its accounts but also lost its reputation in the global Pharmaceutical industry that led to its complete business closure. On the similar lines, State of Texas filed a petition against Pfizer Inc. for its falsified data and failure to pursue adverse event reports in its COVID-19 vaccine trial, seeking injunctive and monetary relief worth more than USD 1,000,000.

The Imperative of Data-Driven Transformation: A Path to Data Mastery

To fully overcome such situations where business reputation is at stake, business processes become inefficient and error prone, and financial losses become a new normal, it is extremely critical for Pharmaceutical companies worldwide to understand the essence of data and the need to implement a robust data management strategy as well as infrastructure that is capable of handling high volumes of data from disparate sources without compromising on security and compliance.

Implementing a comprehensive data management strategy involves several key steps:

• Data Governance: Establishing clear policies and procedures for data collection, storage, access, and use.
• Data Integrity: Ensuring data accuracy, consistency, and completeness through validation and cleansing processes.
• Data Security: Protecting sensitive patient data from unauthorized access and breaches.
• Data Integration: Combining data from various sources to create a unified view.
• Data Analytics: Utilizing advanced analytics tools to extract insights and make informed decisions.

PureSoftware: A Trusted Data Partner

PureSoftware, a global software products and digital services company, has been driving transformation for pharmaceutical businesses worldwide with its comprehensive suite of data technology solutions, helping these companies navigate the complexities of data management.

By partnering with PureSoftware, pharmaceutical companies can:

• Generate data-driven insights from raw data by leveraging BI and data visualization
• Ensure data integrity, improve decision-making, and enhance operational efficiency
• Seamlessly transfer data across systems with uncompromised data security
• Overcome the challenges of data and information overload during clinical research
• Establish effective data management policies to mitigate data breach risks
• Optimize data storage and retrieval by centralizing data into a single repository

For more information about PureSoftware’s life sciences and healthcare capabilities, please visit here.

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Author:
Prasoon Agrawal
Senior Vice President and Business Head Americas