In order to ensure the optimal trial outcome and smooth execution of
clinical trials efficient site management is highly imperative. What can positively impact the quality of data collected and make sure the study is concerned according to the agreed timelines and within the budgets is choosing the sites as per the study protocol as well as the applicable regulatory requirements. Proper site management facilitates sites to both recruit & retain subjects effectively at the same time adhering to the study protocol & relevant regulatory guidelines.
Site management in
clinical research trials comprises effective site monitoring as well as constant communication among the several stakeholders throughout every phase of the clinical study – study start-up, study conduct & study closure.
“India as a clinical trial destination has undergone a course correction in the early part of the last decade. Regulatory processes have evolved and been streamlined over the last three years. It is reflected in the New Drugs Clinical Trial Rules (2019) which provides clarity on a few areas that are imperative for conducting global clinical trials. We have witnessed global biopharma showing renewed interest in including India as one of the key countries to conduct clinical studies,” says Abby Abraham, Global Head, Data Science & Country Head – India, George Clinical.
Cutting down costs
While Clinical trial site management costs sponsors as well as CROs millions of dollars every year, a recent report stated that complete clinical trials cost somewhere around USD 44 million and USD 115 million each. Out of those costs, around 11 to 29 percent are from paying administrative staffs, and 9-14 percent are from site monitoring & 9-16 percent from site retention and this means clinical trial site management makes up anywhere from 29-59 percent of the total cost of a trial. Therefore, if sponsors can cut down on these costs, they can save tens of millions for every trial.
However, achieving this is not easy as cutting down on administrative as well as site monitoring
costs without compromising the safety of clinical trials is a little difficult. Hence to make it easier there are a list of strategies used by other sponsors and CROs which can facilitate CRAs manage sites, enable remote monitoring as well as save millions without compromising on regulatory compliance.
1. Finding out the right technology for clinical trial site management
76 percent of sites and sponsors stated that most of their monitoring visits were remote in 2020, which is 18 percent up from that in 2019. Although the switch to remote monitoring was augmented by the pandemic, the industry is not looking back since 80 percent of sites now anticipate most of their monitoring to be remote by the year 2023.
In order to make remote monitoring feasible, sponsors & CROs are required to establish a technological link with the sites they work for. As a 1st step, most of the sponsors turn to email or online storage drives. However, these forms of tech are actually not designed for clinical trials and often are not secure or FDA-compliant too.
Although technology developed particularly for clinical trials is more likely to comply with FDA regulations & ICH GCP standards, compliant software is not just the requirement as we also require a software which will align with your workflows as well as the workflows used by your sites.
2. Look for site focused software
Some of the sponsors as well as CROs rely on sponsor-controlled portals for connecting with their sites. However, these portals come with an extra step on document management. Since sites should store documents in their own workspaces, and later upload those documents a 2nd time to the sponsor portal, it reduces the speed of studies, and increases start-up times, which leads to frustration for sites that may participate in fewer studies. Therefore, with an aim to avoid these delays, sponsors & CROs have started using site-focused software for clinical trial site management.
Site-focused software provides study sites their own workspaces through which they can save and store documents. This is built by keeping the sites’ workflows in mind since they can complete studies faster. Sites can also give permission to their sponsors for viewing documents within the software in order to monitor, SDV and SDR.
Conclusion
“India is a promising market for global medical device innovators. New regulatory requirements for registration of medical devices and submitting post-marketing safety data in India is a welcome move that streamlines this segment and ensures safe products and with assured quality is only used in the Indian population. This is already having global medical device-focused organizations conduct clinical trials to support the registration of their product in India,” says Abby.
The right clinical trial site management software will help in enabling in looking on the crucial monitoring activities. Therefore, it is important for the sponsor or CRO to embrace tech as it could make clinical trial site management highly efficient without sacrificing the safety as well as efficacy of the studies.
