Ryan Jones is co-founder and CEO of Florence Healthcare, a leading testing software company.
The clinical trial industry has followed the generation at an unexpected pace in 2021. According to WCG Avoca, 97% of clinical trial sites had at least one form of remote generation as of June 2021. 89% of sponsors have followed decentralized clinical trial generation, and 88% of sites use or plan to use electronic consent software in form (eConsent). This is an update at a speed our industry has never noticed before.
I expect this update speed to continue until 2022. Regardless, slow users will adopt the technology, and other clinical trial organizations will upload software they don’t already have, whether it’s electronic investigator site files (eISF), eConsent, or electronic source knowledge (eSource).
So how can clinical trial technology corporations prepare for the rest of 2022?Here are 4 predictions about where the generation of clinical studies will pass in 2022.
1. Understaffed clinical trial sites shall use sponsors for other people and additional technologies.
Biotechnology and pharmaceutical sponsors will play a key role in 2022. Like many fitness organizations, clinical trial sites suffer from shortages. Given the prevalence of Covid-19 variants and hiring difficulties in the United States, this challenge is unlikely to go away as 2022 continues. .
Sponsors, especially major sponsors like Pfizer, AstraZeneca or Eli Lilly, have the generation and financial resources that small study sites don’t have. Therefore, sites will turn to sponsors for processes and software to help them manage their data and documents.
But sponsors can only provide this assistance if they have significant physical or virtual connections to the sites they want to support. These connections deserve to allow sponsor study groups to collaborate with the sites. This is where generation providers come in. In the past, vendors have created software for sites or sponsors. In 2022, we’ll have to focus on software that connects sponsors and sites.
2. La test generation will evolve into integrated, vendor-agnostic solutions.
Clinical trial professionals want to connect to multiple software solutions, each with a different purpose, to perform critical tasks. In a CRPA survey, two-thirds of respondents said their generation systems did not reduce duplicate data entry.
By moving to integrated responses that represent percentage data, clinical trial groups can reduce this duplication of work. With staff shortages, strict exam deadlines, and the continued need for accurate data, integrations will be more important than ever in 2022.
To create built-in generation networks, look for vendors with an open API to enable integrations between other vendor platforms. This is imperative because the clinical trial industry has many applications. Finding a vendor that excels in eConsent, eISF, eTMF, ePRO, eCOA, and CTMS software (among others) is almost, because studies are very important and the demand for functionality for a given generation is very important.
Clinical trial organizations will be more successful if they source from generation suppliers in 2022 who meet their broad wishes and are willing to integrate their products rather than sourcing from a single supplier to meet all their desires.
3. La exception will be one hundred percent follow-up of on-site tests; remote tracking with generation will be the norm.
One of the ultimate responsibilities of a sponsor is to monitor the protection and integrity of clinical trials. Whether they themselves supervise study sites or outsource follow-up to a contract study organization (CRO), sponsors have a final duty to ensure that sites comply with safety protocols and standards.
The pandemic has made remote tracking more critical than ever, as sponsors’ access to study sites was restricted. Eighty-seven, according to one hundred sponsors, now use centralized remote tracking software to view documents and data online. But now that a COVID-19 vaccine is available, remote tracking is here to remain because of the increased intelligence brought through virtual surveillance and the need for CROs to manage the capacity of Clinical Research Associates (CRAs).
The consistency of remote tracking will also help another challenge in CRO’s global billing. A 2020 study found that ARC turnover rates ranged from 24% to 29% in the U. S. In the US and between 14% and 22% internationally. Rates are also similar for clinical research coordinators (CRCs) of the site. Keeping all information stored in a single data source available remotely allows jobs to continue predictably when a painter leaves a site or a CRO.
These high turnover rates, combined with a shortage of fitness staff, will mean fewer CRAs will have to monitor more sites in 2022. Promoters will rely on remote tracking software to make this possible.
4. La industry will automate and generate virtual reports as it moves toward decentralized testing.
Previously, the focus on clinical trials was balanced between sites and sponsors. With decentralized clinical trials (DCTs), this effort is moving more toward the edge of the price chain: to access things like CVS and inpatients.
As works move away from sponsor influence, those sponsors will expect the software to deliver workflow automations that query sites and access issues through commissioning, reporting, and the end of the study. Automation and more important reports as top touch search volume of perhaps less experienced personnel in DCT. Automation will come with intelligent alerts to get certain responsibilities finished and documents updated.
Meanwhile, the reports will come with automated knowledge analytics, drawing the attention of clinical trial practitioners to trends in patient knowledge they have collected. Automated reports will also summarize knowledge not only from labs and sites, such as in the classic study price chain, but also from home health care providers, issues, and local devices.
Sponsors and researchers want a single source of data to draw definitive conclusions. As DCT becomes more common, the industry will rely on generation platforms to create this unique source through integrations, automation, and synthesis.
By 2022
Clinical trial software corporations will face a number of exciting demanding situations this year. We want to ensure that our product support sites and sponsors connect, integrate with other software solutions, enable remote monitoring, and offer as much automation as possible. Otherwise, it will stop the studies to carry it forward.
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