Ana Pulido
Director General

Digital Tools Streamline Clinical Trial Processes

Wed, 09/07/2016 - 17:14

Even though IT tools serve a broad spectrum of areas in different industries, Mexico’s clinical research segment is still highly under-attended. International CROs are forced to bring solutions from foreign providers as there are no local digital and electronic solution developers for Case Report Forms and clinical trial management systems (CTMS). This is mainly due to local authorities requiring paper records of all data generated by clinical trials. “Users are continuously seeking solutions that can adapt to study requirements so we develop specific solutions for them including support and training,” says Ana Pulido, Director General of Digitalizatxt. International platforms often require stable and innovative infrastructure in the clinical site to run effectively. However, this is not always true for all clinical sites in Mexico.

“The development of the eCRF took us two years, electronic data transfer (EDT) one year and the CTMS is taking us three years,” says Pulido. “We are also developing the trial master file solution. It is important to highlight that our solutions are integral and interoperate among them meaning our customers do not have to deal with individual tools.” Integral solutions allow users to have access to information on all platforms instead of importing and exporting data from one platform to the other. According to Pulido, this is a software solution that uploads data to the cloud instead of relying on a server so customers do not need to invest in sophisticated, expensive infrastructure and technical staff. Digital technology is gradually replacing electronic systems worldwide. If appropriate security measures are taken to protect confidential information such as clinical data companies become more competitive as they can focus on their core activities and avoid maintenance of expensive hardware, software, IT staff and infrastructure. Companies can save up to 30 percent with digital solutions and even if the set-up cost can represent a significant investment for them relying on paper can be more expensive in the long term, considering time, quality and productivity. Data analysis is much easier when the information is generated by clean and organized digital sources, which improves decision making and data integrity and reduces approval times.

For Mexico to reach its full potential in the digital healthcare field, authorities still need to modernize their processes and requirements. “Regulatory authorities still ask companies conducting clinical studies to keep physical records of clinical data,” says Pulido. She adds that a shortcut to a better competitive position in the healthcare and life sciences sector consists of incorporating digital solutions that help processes be quicker, safer and more reliable.

A number of companies have tried to enter the electronic records market in the last three years but only now is the business opportunity attractive. “In the past, many companies used to see digital technologies as an unnecessary expense but they are becoming aware they need to adapt to this global trend,” says Pulido. This digital platform already has been used by several CROs with favorable feedback.

There are still many gaps to be closed in the clinical research industry such as eliminating manual data manipulation because it can take weeks to transfer information from devices to electronic databases. But the EDT solution can reduce the work of an entire week to three minutes. “Our clients have become aware of the benefits of these tools. But greater effort is needed to explain the importance of optimizing processes with the aid of digital solutions,” says Pulido.

As a consulting company for IT solutions, Digitalizatxt has several business units including Naat Solutions, Naat Health, Naat Knowledge, and Naat Mobile. Naat Solutions and Naat Health are dedicated to clinical research and provide solutions such as the eCRF and the CTMS. Naat Knowledge is focused on training for several sectors such as finance, education, medicine and law, among others. It consists of a learning platform for online programs. These platforms help save costs associated to logistics, and transportation incurred by companies interested in training employees in different cities. According to Pulido, when employees are trained by different instructors they do not receive the exact same information, which is something that can be avoided with online platforms. As for Naat Mobile, it enables customers to have a broad range of educational, entertainment or business solutions in their smartphone or tablet, which is also an important trend today. Business people spend much of their time travelling and the use of mobile technologies has become quite popular and useful for business management. Digital services are changing the way companies develop new drugs in terms of time and patient empowerment. Future plans of Digitalizatxt include a patient diary where information regarding medicine intake and lifestyle changes can be uploaded. “We expect digital healthcare to greatly increase in the next five years and we want to be there when the market starts booming in Mexico,” says Pulido.