Technology is the enabler of smarter, safer clinical trials. Implementation of advanced technological solutions have largely contributed to the growth of Indian clinical trial service industry. Sachin Jagdale reports
Technology till now
Eric Hodgins Sr. Vice President IT, Quintiles |
Technology is the basic requirement for any clinical research organisation (CRO). Clinical trials generate a lot of sensitive data which is needed to be managed and protected. Eric Hodgins, Senior Vice President, IT, Quintiles says, “A clinical trial is, at its core, an information management process that must protect patient safety and ensure data integrity. For many years now, technology has enabled that process, helping it go faster and improving the quality along the way. Standard solutions include clinical trial management systems (CTMS), electronic data capture (EDC), interactive voice response (IVR), laboratory information management systems (LIMS), ECG monitoring and safety surveillance. A robust data infrastructure, systemic approach to integration, and analytics capabilities are also key pieces of any framework.”
One can find niche providers of any one of these systems and many of the bigger service providers will offer all these capabilities. Hodgins talks about his own company’s initiatives. He adds, “What Quintiles does that’s materially different is that we provide solutions to our customers not just technology. We integrate the systems, data and process with Quintiles’ experience in an end-to-end platform for the industry called Quintiles Infosario.”
While Quintiles’ approach is to take advantage of global platforms wherever possible, local requirements have driven them to evaluate the need for local platforms. These platforms are typically simpler and are delivered at a lower price point to meet the demands of local business and customers.
IT perspective
It is impossible to perform clinical trials without an involvement of Information Technology (IT). Almost every major IT company has made available its services for clinical trial industry. Every new discovery and disease pattern make clinical trial more complicated and more challenging. The data generated out of these trials is enormous. To streamline this data IT is very necessary.
Harshal Shah Head-Clinical Informatics Group, Persistent Systems |
Harshal Shah, Head, Clinical Informatics Group, Persistent Systems informs,“Informatics for the clinical trial field is going through rapid change to cope with modern molecular biological technologies. These modern technologies make it possible to probe and understand the genetic basis of diseases, opening the possibility of personalised medicine. But this comes with an avalanche of data that cannot be analysed using traditional methods. Effective use of IT plays a vital role in improving clinical trials efficiency and there by leading to faster time to market with respect to drug discovery. Clinical informatics also helps in providing personalised care improving patient safety and care.”
Increased use of mobile devices in the IT has improved distributed nature of clinical trials. Clinical trials can now also be much more global than before and managing global trials have become much easier, thanks to the involved and efficient use of informatics.
Technology is transforming the biopharma industry in the same way other industries have been transformed in the past decade.
“The biopharma industry is complex and our customers face unique and significant challenges. The delivery of IT in this sector requires business domain expertise to set up and configure solutions that meet the development and regulatory requirements. Technology is being leveraged to deliver significant advantages to the industry including automation, process optimisation, and data transparency. In addition, the clinical industry handles vast amounts of data that involve integration needs, bringing IT into the delivery cycle. These advantages allow our customers to bring drugs to market faster and with a greater level of quality,” says Hodgins.
Shah feels that translational research informatics, which is a sub-domain of medical informatics, has gained significant importance due to the increased mutations in disease patterns, changing lifestyle patterns and increased risk of diseases through genetic malfunctions. According to Shah, major pharmaceutical companies are planning to invest in translational research with an aim to provide researchers with unique resources and expertise to translate research findings into novel therapies that will further help to improve the efficiency of drug development process.
IT into logistics
Proper and secure handling of clinical trial samples has always remained a challenge for every clinical trial service provider. There are many companies that are providing logistic services for this purpose. Marken is one such globally recognised logistics service provider. As supply chain solutions provider dedicated to the pharma industry, Marken offers a broad range of services along the clinical trial supply chain.
Sascha Sonnenberg Vice President, Business Development, Marken |
According to Sascha Sonnenberg, Vice President, Business Development, Marken, pharma companies are focusing more and more on tools that are helping them to get complete overview of there clinical trial supply chain. He explains, “SAP, Oracle are only the vanguard of a broad range of tools that can provide such information and in most cases they are interfacing with other internal tool such as IRT/IVR or IT systems on the vendor site such as logistics or warehousing-/inventory management tools.” Sonnenberg adds, “Pharma companies are facing the arriving shockwaves of the patent cliff in 2016. Cost pressure and re-organisation are terms that we are meeting across our client base. A common reaction to face such challenges is to reduce costs in the area of human resources. On the other side the general workload, e.g. number of studies remains the same or is even increased.”
Tools like Marken’s MAESTRO system can help to increase efficiency, communication and quality in the area of logistics of clinical trial samples by providing a central information platform on day to day operations such as shipments, but also as management information system by providing performance and quality reports or even complete sets of Key Performance Indicators (KPIs). “However, this is only a small part of the overall supply chain were IT can help supporting the daily workload clinical trial project managers are facing,” asserts, Sonnenberg.
Regulations and cost pressure are the major drivers for trends in logistics of clinical trials. Trends driven by regulations are for sure an increasing demand on temperature monitoring. According to Sonnenberg, the focus in this area is clearly on solutions that can be accessed via touch-less technologies such as Near Field Communication (NFC) or Bluetooth via a mobile device, for e.g. mobile phone to read the monitored data. Temperature deviations can be tracked and communicated much earlier using this kind of technology and therefore this helps to shorten the time to initiate a new drug shipment.
The IT applications help at various stages in clinical trials solution workflow. These applications benefit each phase of the workflow to ensure that trial runs smoothly and are automated wherever possible.
Persistent Systems’ Clinical Data Management (CDMS) helps to monitor sites and patients to
implement case reports.
Hi-tech future
Like with other industries, advancements in IT sector are going to impact the clinical trials industry as well. Increased adoption of IT has already facilitated more global studies in the clinical trial industry. “Clinical trials will be much more distributed in nature since this can be easily maintained by an effective informatics solution. Use of IT will also ease a participant’s registration process and hence increased participation. Mobility based solutions will allow participation in clinical trials from the home rather visiting a hospital or clinical research/trial center. Personalised trials and personalised care will be more common thanks to the increased use of IT and data analytics. Information processing will be considerably rapid and hence reduction in time to market,” predicting the future scenario as far IT penetration into clinical trial sector is concerned, Shah says.
India has already established itself as a generic superpower. India’s IT prowess is also globally accepted. Clinical trial is but another segment where this dual superiority can reinforce Indian advantages where we can be a super power.