Key Regulatory Compliance Challenges Facing Life Science Organizations

Blockchain can help with some of the industry's most concerning regulatory and compliance problems.

Fremont, CA: A paradigm change in the life sciences industry is now getting brought about by new technologies, including blockchain, artificial intelligence (AI), and robotic process automation (RPA). These technologies can fundamentally alter operations and the way the industry approaches regulatory compliance challenges.

While RPA and AI have long since made major strides, blockchain advantages are still slowly realized.

Global businesses must abide by local and international standards to receive regulatory certification because healthcare legislation differs by region. In this situation, a hybrid blockchain implementation method to conquer compliance can be quite helpful.

Information may be stored and transferred securely across a peer-to-peer network using blockchain technology. On the blockchain, every information transmission gets authenticated by a number of network members. Regulatory agencies will find it simpler to evaluate the integrity of the documents.

Let's examine how Blockchain can help with some of the industry's most concerning regulatory and compliance problems at the moment.

• Pharmaceutical supply chain 

A blockchain-based system can increase supply chain openness and visibility for the pharmaceutical business, making it less expensive for regulatory agencies to track pharmaceutical items. At each stage of the drug's journey, all regulatory parties may use information systems built on blockchain that contain information like expiration dates and certifications of origin.

• Subject identification for effective clinical studies

Blockchain enables doctors and researchers to keep their observations on the same chain, while patients may preserve their medical data and contact clinical trial recruiters directly. In this approach, role-based access will ensure that patient data is safe, unaltered, and available to the appropriate parties.

• Communication between regulatory agencies and pharma sponsors

Blockchain enables collaboration with functional contributors, including regulatory bodies and pharmaceutical sponsors, and enables life sciences businesses to build a framework to handle submissions. Relevant data can be published on a public blockchain node and made available to parties interested in creating safety precautions, clinical studies, or cross-border compatibility after the sponsor has regulatory permission.

• Using smart contracts to standardize content

Smart contracts assist in establishing a single source of truth for all life science data and assure stakeholders of trustworthy execution of the contracts at a much faster rate than the existing approach. In addition, blockchain provides better communication protocols with smart contracts, and data can get easily transferred and kept anonymously.