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The very essence of a true entrepreneur lies in the ability of an individual to identify challenges as opportunities. The story and career trajectory of Rama Rao, CEO, and founder of Bloqcube®, follow a similar trail. Having been in the pharmaceutical industry for over 27 years, serving in multiple senior roles, Rao observed several strategic, operational, and tactical challenges in the clinical trials space. These included challenging issues like data integrity, deployment of siloed, legacy software systems, uncertain or delayed payments in the clinical trial cycle, and other problems combine to create far too many headaches for everyone involved with clinical trials while slowing down the development of medicines and the release of life-saving medicines to the public. While searching for a way to solve these issues, the idea of the decentralized clinical trial was born. He thought this notion could be the future way of conducting clinical trials. To bring this idea to reality, he established Bloqcube® in NJ, a highly innovative company that has built a decentralized software solution for clinical trials. Gartner Group ™ had listed it in the Hypecycle™ report for 2020 in their section on Life Science and Blockchain companies. Today, the company is known for its transformative technology for the efficient management of remote clinical trials. “Our ultimate objective is to use innovative technology to solve the problems in clinical trial space by bringing the trials to the patients instead of taking patients to trials,” says Rao.

In every crisis lies a seed of opportunity. The current COVID-19 pandemic has brought the entire world to a standstill. It has obligated every industry, including pharma, to shift entirely to the digital world and remote working to prevent virus transmission risk for both site staff and patient.

Our ultimate objective is to use innovative technology to solve the problems in clinical trial space by bringing the trials to the patients instead of taking patients to trials

Besides, substantial portions of resources are allotted to the development of COVID vaccines, which has created an execution challenge for the trials of other diseases, hindering the early development of treatments for non-COVID patients. Against this devastating backdrop, Bloqcube® has emerged as a novel alternative. The company’s solution perfectly aligns with the current regulation from FDA, which says clinical trials must take place by securing patients'/subjects’ safety in the trial. To meet this end, decentralized trials are a key solution.

Bloqcube® uses a cloud-based electronic data capture and distributed ledger and technology to accelerate clinical trials to deliver real-time immutable data transparently and provide fully decentralized remote clinical trial management tools. Blockchain technology and its cryptographic algorithms lay the foundation for the governance of the trials, which allows them to maintain data integrity and security. In fact, Bloqcube® is one of the pioneers, if not the first, in identifying the advantages of Blockchain and applying it to accelerate clinical trials and drug development.

The current clinical trials industry is faced with a suboptimal financial system, with limited integration into accounting; additionally, sites are paid late, endangering their financial health, imperiling their solvency resulting in high dropout rates. Bloqcube® addresses this issue through its integrated financial module. The financial module is called Continuous Clinical Trial Accounting (C2TA™). It uses an algorithm within the financial system called the smart contract that automates specific processes for the payments due and accounts for it.

It gives users a real-time view of their current resource position and enables them to make informed decisions to enhance their business growth strategies. Another interesting aspect of Bloqcube® is that it offers a lesser degree of vulnerability to ransomware attacks.

Substantiating the efficiency of Bloqcube®’s CTFMS, Rao cites a case study of an academic medical center that was performing an observational diabetes study from an area in South India. This study required visiting the patient’s homes to collect data and effectively pursue the study. Bloqcube®’s platform allowed them to collect data from the patient’s location easily. They were able to effectively collect data from 150 selected patient’s homes in just 12 days. Additionally, the principal investigator received a daily report of the patient’s condition and was able to view the complete patient’s details. “Besides, e-signature, our electronic informed consent module has capabilities to translate the entire study into the patient’s language ensuring that the patients with inadequate literacy or no knowledge of English are informed suitably,” adds Rao.

With their exquisite mission of accelerating trials for patient’s benefits, Bloqcube® is striving to explore areas of rare diseases where treatment options are negligible. Besides, they are looking towards engaging with larger trials with over 200 to 300 patients. They are also focusing on the future of AI, NLP, Gaming, and other technologies to improve clinical trial space. However, Rao believes in strengthening Bloqcube®’s foundation before enhancing platforms and technologies. They have also submitted an application for a grant from the NIH, specifically NIDA, for leveraging Bloqcube®’s technologies. As a part of the expansion plan, Bloqcube® is looking to extend its footprint and deliver the platform to customers worldwide. “Like all the other entrepreneurs, even we have very lofty ambitions and a truly clear picture of the process to get there. To achieve it, our first step is to strengthen our platform and demonstrate our execution capabilities with our base offering,” concludes Rao.