With COVID-19 restrictions on travel, traditional monitoring and quality management of sites are not only expensive and time-consuming but also impossible. However, the clinical monitoring function remains vital for ensuring that clinical trials are conducted in a safe, effective, and accurate way. In the context of pandemics, remote monitoring became an absolute necessity, making it a solution that more and more companies are embracing.
There are a lot of technology solutions for remote monitoring available on the market. When a Life Sciences company decides to adopt a remote monitoring model, it has to answer a challenging question – “How to choose the solution that will be the most beneficial for me?”.
Business analysis approach will allow you to pick the right remote monitoring solution that fits your present needs and anticipates the future ones.
In this article, we will cover the main elements of the business analysis process. Taking them into account will help you to embrace the remote monitoring solution in a strategic and proactive way, optimising its implementation and supporting the organisational changes around it.
What is business analysis and why do you need to conduct it?
The business analysis allows you to identify the business needs and determine the right solution to your challenges. With a business analysis approach, you will be able to consider not only a software-systems development component but also process improvements, organisational change, and strategic planning and policy development. Such a holistic view will allow you to increase the benefits from your new remote monitoring solution and to harness fully the power of technology.
Why conduct business analysis?
- Investigate business systems and get a holistic understanding of the situation
- Evaluate actions necessary to improve the operation of a business system
- Document the business requirements for the IT system support using appropriate documentation standards
What are the main elements to cover during business analysis?
- Company strategy
- Change management
- SOPs and Processes, Regulations
Element 1: Technology
A number of technology solutions that are already available on the market allow you to perform remotely all tasks that are usually carried out by the monitors on-site. This includes such solutions as eTMF, EMR, eISF, rSDV, eCRF, RBM.
These solutions are available either on-premise/hosting or as a SaaS model. While choosing the right technology, you would need to take a strategic decision on whether you would like to manage the technology yourself or delegate this work to the vendor, and based on this choose the on-premise/hosting or SaaS model.
Change governance is another very important aspect to consider while deciding on technology. This involves buy-in commitment, communication between stakeholders, and training and coaching of employees who will work with this technology.
Element 2: Business strategy
In order to choose the most suitable remote monitoring solution, your company has to decide how it wants to embrace technology in the next years. It is crucial to identify the right partners that will accompany you on the road you choose. An expert partner will identify possible digital solutions and deliver data-driven recommendations for the strategy. It will evaluate which elements of Digital Transformation are technologically feasible and financially and functionally reasonable and will help you to achieve the desired goal.
Element 3: Change management
The success of remote monitoring project depends heavily on the effectiveness of change management strategies of the company.
Successful change management involves all the stakeholders, which means that remote monitoring projects should be done with them, and not for them. We recommend including the following activities in your change management process:
- Involve key stakeholders
- Foster their commitment
- Communicate effectively
- Focus on remote monitoring advantages
Element 4: SOPs, Processes, Regulations
Remote monitoring is a new paradigm in clinical trial development. The company QMS must be radically changed in order to face this disruptive task, going beyond established practices.
As part of the QMS change, you may face the following challenges:
- Foster the digitisation process maintaining compliance with the regulatory requirements
- Setting up the consent to the processing of personal data that allows sharing it with monitors for remote monitoring purposes and takes into account UE 2016/679 GDPR as well as other local regulations guarantees the patients’ privacy.
Element 5: Budget
Last but not least element of the business analysis process is the budget. Remote monitoring allows you to drastically lower travel costs and at the same time increase the profit from monitoring activities. These savings and additional profits can potentially cover the cost of the adoption of the new remote monitoring solution.