Remote Monitoring Clinical Trials
Remote monitoring clinical trials consist of an off-site assessment conducted by the monitor away from where the clinical study is being carried out. Currently, remote monitoring has been globally embraced due to the current global pandemic. Remote monitoring is now a vital component of the clinical trial procedure and an essential nexus between the study site, the sponsor, and the clinical research organization (CRO).
The CRO and the sponsors must ensure that the investigation site carries out the trials directed by the protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and any other governing requirements. To monitor these undertakings, CROs and sponsors have in the past kept an eye on a site by sharing data via emails and fax and conducting onsite visits.
Remote Monitoring Clinical Trials: Why You Need To Utilize Them
- Remote monitoring refers to an off-site assessment conducted by the monitor away from where the clinical study is being carried out.
- Traditional Monitoring Approaches are being faced out due to the difficulty in trials and the hurdles to site access caused by COVID-19.
- Remote Clinical Trial Monitoring has numerous benefits, including tracking of research progress.
- Sponsors and CROs are having a hard time trying to blend new technology with the existing platforms.
Problems of Traditional Monitoring Approaches
In the past, onsite monitoring visits were a quintessential part of the whole lifecycle of research. Nonetheless, the demand for remote connectivity and sophistication of clinical trials has made numerous organizations look for cheaper and efficient alternatives. Now, the global pandemic has accelerated the search for remote monitoring clinical trials. The impact of remote monitoring on the outcome of clinical trials is becoming apparent with each new trial. The main issues with traditional monitoring approaches include:
- Incrementing Number and Difficulty of Trials
Registered trials have doubled in number since 2015. Unfortunately, the trials are not only growing in numbers but also in difficulty. On the other hand, monitors face incrementing pressure from the CROs and sponsors demanding a near-time oversight. Blending this with huge data sets affects extra strain on the conventional monitoring methods, which leads to slower research progression and possibly timely hold-up.
- Hurdles to Site Access
The need for digital connectivity has risen for the last ten years. And the current global pandemic has incremented the need for a quick digital fix because of the travel bans, heightened safety precautions, and restrictions.
Historically, software sellers playing the role of CROs and sponsors have attempted to solve this puzzle by utilizing a “sponsor-first” program to research sites. These programs have not been fully embraced since they bring extra workload, many portal logins, and fragmented procedures.
Benefits of Remote Clinical Trial Monitoring
Purpose-built systems, which enable clinical trial monitoring, generate cross-organizational efficiencies when the software seller considers both sponsor and site workflow requirements. Businesses that benefit from a LIMS system can also benefit from remote clinical trial monitoring. Rather than affording a “site portal” only to the study sites, CROs and sponsors are catering for the wants of a site in two ways: Integrating with the site’s existing platform or utilizing an Electronic Investigator Site File system, which is linked to the CRO’s Electronic Trial Master File.
A digital network, which allows remote clinical trial monitoring is laced with the following advantages:
- Improve Remote Site Access
Digitally linking the sponsor and site system enables the monitor to safely retrieve the trial documentation from any place in the world and at any time. The ability of the monitor to access trial documentation remotely means that onsite restrictions or even travel delays cannot limit him or her, and this saves him or her a considerable amount of time while lowering the entire expense.
- Effective Communication between CRO or Sponsor and Site
Numerous innovations, which permit remote monitoring are laced with features that enable streamlined communication, such as dashboards and notifications. These features decrease communication delays.
- Tracking of Research Progress
When clinical trials are digitized, one can keep an eye on research progress and site performance without involving the site staff. Monitors can set notifications for activity completion, and this will eliminate time wastage.
- Regulate Repeatable Workflows
The traditional approach utilized paper, and this restricted the ability for repeatable workflows to be made efficient. On the other hand, with innovation fuelling these repeatable processes, they can be made once within a process and implemented in a few clicks.
Challenges That CROs and Sponsors Face When Implementing Remote Monitoring Execution Implementation Tactics
- One of the hurdles in this process is blending new technology with the current platforms. Every site is peculiar, and most already utilize CTMS and eRegulatory solutions.
- Lack of robust integrations and integrated workflows can cause work duplication when innovations are executed. To surpass this challenge, select a software seller who is dedicated to integrations. Always keep in mind that interoperability is fundamental.
- Another challenge is the risk of poor adoption. New platforms demand training for one to become efficient. A software seller with an already known execution process, a well-organized support strategy, and role-dependent training plans should be selected to help ease the risk.
- The final challenge is authenticating software seller Quality Assurance and risk management that are typically a concern for sites. Numerous sites are not acquainted with utilizing or assessing innovation vendors. Hence, it can get overwhelming when a CRO or a sponsor decides to impose a new tool.
Nonetheless, you can address these challenges by finding a software seller like ObvioHealth.com who not only stands by relevant guidelines but lends a hand when you are implementing his workflows and innovations and avails resources and a dialogue to tackle the questions and worries.