Denver Health

Ricky Lopez

The establishment of open technology standards will enable pharmaceutical companies to introduce enhanced connectivity and efficiency into the clinical trials when collaborating with CROs.

The life science industry has experienced tremendous growth over the last few years. The innovation has accelerated the flow of drugs into the market. In the year 2018 alone, 59 drugs were approved for medical use. Although it has given great hope for personalized treatments, the cost of developing complex therapies has dramatically escalated.

Presently, the average cost of phase II clinical trials can range from $7 to $19.6 million, whereas in the case of Phase III clinical trials, it is as high as $52.9 million. Also, trials have prolonged timelines and can contribute to study delays and expenses. Although several sponsors hire contract research organizations (CROs) to conduct clinical trials, the absence of uniformity in data can drive up the time and cost needed to introduce new medicine in the market. The disparate systems and standards also make information sharing a challenging task.

Clinical outsourcing is being leveraged by sponsors to conduct almost all the phases of drug development, including preclinical research, clinical testing, and post-approval functions such as monitoring, consulting, commercialization, and safety management. Since many of the organizations plan on contracting multiple specialized services, it will introduce more complexity in terms of collaboration. The CROs often utilize disconnected technologies to conduct their tasks, which create more obstacles in the way of effective communication and data exchange.

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The information exchange is often carried out through e-mail, which might require manual reentry into different systems. There is little visibility in the processes, which often forces the sponsors to conduct regular audits to maintain accuracy in the data. Ultimately, it is not the CROs, but the pharmaceutical companies which hold responsibility for the clinical trials.

The implementation of a connected clinical network bolstered by open technology standards can significantly enhance productivity, reduce expenses, and streamline the clinical trials. Also, it can help the organizations in addressing the collaboration and technology challenges involved in the trial operations.

Several technology providers such as Veeva Systems are gathering input from the industry at large and collaborating with research organizations to develop open technology standards. Their purpose is to streamline information sharing during trials and offer enhanced visibility to the sponsors when working with CROs. The common standards will allow both parties to enhance efficiency and mitigate the risks involved in the clinical trials.

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