7 Must-haves in a Clinical Trial Management System

Just like every person is different, each vendor has separate features that define their value as a reliable Clinical Trial Management System. Add to this the current uncertainties due to the Covid-19 pandemic and all the existing practices need a major overhaul to meet the changing landscape. For instance, interest in mobile health applications as well as virtual trials through telehealth visits, etc. are gaining traction. I have put together a list of 7 must-haves when you finalize on a Clinical Trial Management System that will work for you.

Adaptability

The medical field is prone to a constant change in regulatory and clinical requirements. It is important to ensure that your Clinical Trial Management System is ready to adapt to these constantly evolving needs. What is more, such changes should require the least amount of programming changes or the need to rely on the vendor for updates. Lack of such agility will only turn out to be a big hurdle in the long run.

Interoperable

Each visit of the patient triggers off a series of actions that need to be completed i.e. reserve a room for the patient, set up reminders for the patient, order new lab reports, ensure the bill is generated, make information available immediately to the sponsor, ensure post-visit follow up with the patient, etc. A system that is not capable of automating all these chains of events would only result in loss of time and effort as otherwise manual entry of the data would be needed.

Seamless operations

The research process involves a series of actions that are connected and any mistake in them can impact the entire result. Hence it is important to have a system that can reduce the number of manual touchpoints to reduce the time taken to complete the task as well as limit any possible errors. The absence of such an intuitive system would result in increased man-hours for administrative work as well as an increase in training costs to mention a few of the problems.

Communication

Interaction between team members on the operation of such a large scale is very important. With emails, telephone calls, and in-person meetings- information is exchanged in several ways. In the case of Clinical trials keeping team members aware of information in real-time enables them to act on any next steps needed to ensure timeliness of executing tasks. Without such responsive communication, the results of the trials could either be delayed or have errors.

Integration

Every organization already has huge amounts of legacy data that they need to continually access for their work. Hence while selecting a Clinical Trial Management System, it is important to analyze if the system will tie in data from these legacy systems. In addition, it is critical to evaluate the capacity of your current IT department. The key is to understand if the internal team is capable of hosting and maintaining these programs or if it is important to have an external vendor take this up.

Patient management

As mentioned earlier, several Clinical Trials have suffered due to a lack of patient retention policies. An ideal Clinical Trial Management System should be able to address this problem. An agile system should be capable of managing patient recruitment, correspondence with patients during the trial, a reminder for appointments, streamline the invoicing and payment processes, etc.

Security

Last but not the least, regulatory compliance and protection of confidential patient data are one of the most important considerations. The system must be HIPPA and 21 CFR Part 11 compliant. In addition, it should be possible to monitor individual security permission levels as well as maintain an audit trail for reference.

In conclusion, the current fragmented Clinical Trial Management System sector does not have several all-inclusive solutions that will solve all the hurdles in Clinical Trials. It is time to replace old legacy systems with intuitive options that can rise to the challenge and offer intuitive support for future challenges in this field. Considering the rapid discoveries and advances in clinical trials, we need to offer solutions that are cost-effective as well as efficiency-driven.