Accenture Life Sciences perceives that clinical data management (CDM) requires technology and expertise to handle huge data. With site-monitoring and data-management accounting for 25-27 per cent of the total time spanning 10-13 years and amounting to $122 billion of the pharma R&D expenses, there is an increasing move by pharmaceutical companies to outsource the know-how.
According to Balaji CL, managing director, Accenture Life Sciences, innovation-driven outsourcing study designs are becoming increasingly complex, sponsors are becoming more reliant on e: clinical systems to handle complex protocols and handle ever-evolving regulatory requirements. Start-up companies are changing the way clinical research organizations (CROs) and sponsors collaborate through technology. For example, Gobalto’s Tracker (SaaS) makes access to critical data easier. It provides turnkey solutions to empower sponsor companies without having to hire, maintain and manage a large number of resources and programmers. Cloud Clinica is the next generation cloud-based e:clinical platform with an easy-to-use, pay-as-you-go platform to build and manage clinical studies from the ground up without any programming skills.
“The cost of handling data is seen to incur high costs but use of technology platforms would provide the much needed ability to process information faster and also ensure its reusability. Further, the healthcare market dynamics is shifting towards patient outcomes and maintaining huge data. Therefore, there is a huge business opportunity in CDM and disruptive technologies like Integrated Electronic Patient Reported Outcomes (ePRO), Mobile Clinical Studies and wearable devices are transforming CDM busniess, said Balaji at a recently concluded DIA event on Evolving Landscape of Clinical Data Management: Focus on Technology and Data Standards.
The challenge before the clinical research industry is patient recruitment, complex protocols and faster trials. There is need for faster adoption of technology. There are many tech-platforms with no additional investment but would provides the ability to process data at a faster pace. Clinical data management companies in India now need to operate using real time analytics, integrated standards and cloud technology, said stated the Accenture Life Sciences chief.
While ePRO allows patients to report clinical data themselves, cloud-based clinical trials is generating huge cost-efficiency. Mobile clinical studies which allow patients to report data on the move and wearable devices show great potential for patient engagement. The revolution of personalized medicine will encourage conduct of smaller clinical trials enabling individuals to participate in clinical development. Further risk based monitoring helps to create patient profile reports, review and identify data errors besides observe efficacy. These patient profiles automatically run algorithms to mine clinical data and identify the unusual data.
The focus is to create a pool of personnel who have the expertise in CDM with new posts like Data Scientists, Data Validators and Protocol Managers. It helps redefine audit of trials and ensure continuous improvement. The technologies trends like internet and social media are increasingly utilized by life science companies to engage patients in clinical trials, he said.