ICT Magazine interviews Ricky

November 29, 2019

As clinical trials expand and regulations evolve, Ricky Lakhani at PHARMASEAL speaks to ICT about the benefits and challenges of adopting a trial management solution, from its impact on data collection to mitigating costs

ICT: What are some of the marketplace trends for clinical trial management systems (CTMS)?

Ricky Lakhani: Historically, CTMS solutions have been rightly considered expensive, monolithic, and costly to both implement and maintain. Through improvements in technology, this has begun to change with Software-as-a- Service (SaaS) offerings. The continued growth and adoption of SaaS technology solutions, especially with a CTMS, will be a key industry trend in the coming years. This is true for small- and medium-sized companies striving to reduce the cost/ overhead of either home-grown or hosted solutions. Further to that, with the continued focus on data collection and analysis, companies are adopting CTMS solutions to eradicate the inefficiencies of spreadsheets and other manual tools. In regard to data collection, CTMS solutions are increasingly positioning themselves in the middle of an ecosystem of inbound and outbound data, reducing the amount of manual data entry and increasing the transparency of data for reporting and informed decision making.

How can a company benefit from a more adaptive CTMS?

Using a CTMS that is adaptive, both functionally and technically, can benefit a company in a multitude of ways. An adaptive CTMS can improve the ability to manage more complex trials and can substantially reduce the cost and time spent by eliminating duplicative or unnecessary tasks. Furthermore, they can improve communication and increase collaboration across multiple stakeholder groups, providing greater insights into clinical trial data, and thus reducing inefficiencies that have previously existed with siloed business processes.

What should be considered when designing an effective CTMS?

When designing a CTMS, you have to come at it from a number of perspectives, such as technical and functional perspectives, and identifying what your USPs are going to be right up front. As with any other enterprise software, building a CTMS requires some up-front design to ensure the foundations are scalable and maintainable as the product grows over time. Not putting in strong foundations will increase the costs of adding features and maintaining the software. Then there is interoperability – a CTMS should be designed to be able to exchange data with a variety of other systems using mechanisms that can reduce the need for custom point-to-point integration. Then, functionality and usability needs to be at the core. Legacy systems have failed because their focus has been on capturing the data, rather than the outcomes, that the end user needs to achieve from utilising the technology. Other key factors are configurability, ease of adoption through data standards, and pre-configurations to reduce overhead.

What are some of the challenges of implementing a CTMS?

A CTMS will support multiple groups within a sponsor/CRO and different roles at varying levels in these companies. Each will have different requirements and goals, as well as different priorities. Designing and agreeing the future state of business processes to help realise the return on investment on a CTMS is a key challenge to overcome. Other challenges include the lead time required for setup and configuration, and, unfortunately in some cases, customisation − which increases the cost and time of implementation.

How can a CTMS impact on data access and collection?

If the right CTMS solution is chosen and implemented in the right way, the impact on data access and collection should be hugely positive. A good CTMS solution should increase the capture of structured data and reduce the need for data duplication through both inbound and outbound integration capabilities. This streamlines processes and speeds up data collection; it also increases data access for a wide range of stakeholders wishing to have insights into various aspects of the clinical trial portfolio.

In what ways can using a CTMS mitigate costs?

Adopting a SaaS CTMS system in place of an existing hosted solution, or even just to replace home-grown solutions, is the common way to mitigate costs in your trial management spend. However, just replacing the system isn’t the only way to achieve this. Adopting standards, increasing collaboration through the use of a single system, and streamlining the processes of CTMS implementation can all help reduce cost pressures.

What does the future hold for CTMS application?

As indicated by market research, I believe that CTMS solutions will continue to play a fundamental role in the clinical software ecosystem, especially as the number of clinical trials continues to grow and regulations continue to evolve. Markets such as Asia Pacific continue to invest heavily in clinical research, and the new EU MDR legislation could increase the number of trials in the medical device market, potentially increasing CTMS adoption in this segment. Furthermore, I anticipate growth in the mobile optimisation of aspects of CTMS solutions in areas such as analytics, business intelligence, and site monitoring. CTMS solutions will continue to form a fundamental part of the ecosystem of clinical and operational systems that companies will have.

Thanks for reading and if you have any questions or would like to receive a copy of my ICT QA please contact me ricky.lakhani@pharmaseal.co