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A sophisticated clinical trial management system (CTMS) could go a long way to help overcome the lengthy and costly delays involved in clinical studies.
At present, 85 percent of clinical studies are delayed, and 94 percent of these delays are over a month. According to analysts, these delays may cost from $600,000 to $8 million every day. No doubt, these study delays are one of the biggest problems keeping stakeholders on their toes and unfortunately, there isn’t yet a perfect solution.
The reasons for these delays can differ. Many experts say the principal cause is the patient recruitment process or the long startup timelines, but these are not the only reasons. Sometimes meeting the regulatory standards is an obstacle. Sometimes it’s because a strategy is not well-developed, or there are gaps in the process management, or because of communication difficulties. On top of this is the complexity of the studies themselves.
Clinical studies are getting more and more sophisticated, including more procedures and criteria, more countries, and more sites. This means more unplanned time in every phase and respectively – additional costs. And when we talk about the costs, we should not underestimate the budget management and budget delays, which can also be a serious reason for the overall study delay.
The overall budget management includes three main streams – budget income, budget expenditures, and tracking the previous two streams. The financial relationships between the stakeholders are complex as each of them has different expectations, timelines, and plans. That is why the budget should be allocated properly and on time to the different stakeholders and the costs and payments should be constantly tracked and thoroughly planned. “When we enter the execution phase and the payments start running month by month, it’s crucial to know which payments are due, when to expect them, when to expect the payments from the sponsor, when our subcontractors should be paid and on which activities,” explains Ivailo Ivanov, the chief technology officer of BGO Software, the visionary behind Clinicubes’ CTMS.
All these payments can be tracked by an automated clinical trial management system. “There are still hospitals and clinical trial sites which rely on paper-based management and invest huge human and time resources in the process. Others are using Excel-based systems, but they are not sophisticated enough to answer the requirements of these complex studies and to interact with different stakeholders,” says Ivanov.
Each budget differs in structure, counts, and formulas, so the steps that should be taken to go through the different scenarios can differ. “This actually can be a burden for any organisation and lead to serious budget and study delays. Implementing a standardised tool and methods would allow the organisations to handle all these problems,” he said. The other problem that technology could solve is tackling the information spread on different media and computers. The data scattered in different places and sources can be a real challenge to every clinical study. “We must be sure that the information is stored securely in a single place to guarantee the proper execution of the study,” says Ivanov.
The third main reason to implement a CTMS is the necessity of taking quick financial decisions. “We need to be able to respond fast to requests for new studies and to weigh up whether to take an opportunity or not. Also, during the study, we need to make quick decisions and have the ability to identify what goes over, or is under, the budget and whether there are delays in the payments or we need to pay someone on time or we are late. Many cases need a fast reaction, especially in terms of financial relationships,” concludes Ivanov. And not to be underestimated, a good CTMS could grow with your needs, and respectively – with your organisation and studies.
Ivailo Ivanov is one of the speakers at Med-Tech World Summit 2022 and will share best practices for optimising clinical trial budgeting and improving finance tracking while enhancing efficiency. His keynote will take place on November 18th, 14:00h.
Med-Tech World takes place at the same time as Malta Week, SiGMA Group’s flagship event of the year. Combining all of the company’s brands into one massive event, this is the perfect opportunity for delegates to get the best bang for their buck.
Visitors of both Med-Tech and AIBC Summits will benefit from cross-pollination, experiencing the massive overlap between digital health and emerging technology, such as in the use of robotics in surgery, or the benefits of the Metaverse for the life sciences.
The event takes place in November, over two days of panels, workshops and networking opportunities at The Hilton Hotel Conference Centre in Malta.
More information below.