"Born Out of Necessity"
"Born Out of Necessity"
This issue began during COVID-19 when site employees resigned from their jobs everywhere. The long-lasting job dissatisfaction paired with wage stagnation only made things worse. Today, we are seeing the highest rate of resignation in health care ever, which means fewer resources now more than ever. This downward spiral has caused sites to put a hold on new studies, function with 70-80% of regulatory staff, and start studies without even a CRC identified.
We took the time to interview a few sites and sponsors and here is what they are saying:
· “ I am only down to 25% in CRCs – have 4 lost one (the Lead) but also lost physicians. Need help with start-up since this was done by the University. We are drowning.”
· “Research staff is down 40% - we have managers answering the phones. We had 6 studies in the start-up process and stopped. We had to turn them all down. We have not opened any new studies in 6 months. Some of our sites lost physicians, some lost staff, but everyone is overloaded. This is our biggest challenge.”
· “Staff are being hired without research experience making the training curve super steep. You can’t find oncology experience so new hires are learning 2 jobs at the same time – research and oncology.”
· “We are so spread thin that as a CTM I am having to complete CTA and Lab personnel duties since we don’t have the resources. We need another third-party client that we can count on to assist us with getting in the data along with following up with the sites for other ad-hoc requests.”
If the above isn't enough, check out the latest article published by ACRP on September 27, 2022 highlighting the shear CRC scarcity in our industry. Website: rb.gy/br8jp0
The current model does not separate the primary study coordinator and data coordinator due to limited resources.
With CRDC Solutions, the primary study coordinator and site can focus on the patients, while we focus on the data.
Sites can't keep up with basic data entry and query resolutions. It's only getting worse with high turnover and entry-level hires. Born out of pure necessity, especially in the oncology discipline, we solve this bottleneck by leveraging external, remote, highly experienced Clinical Research Data Coordinators (CRDCs) who work in parallel with existing Clinical Research Coordinators and Data Coordinators (if available) from the sites. This proven approach at major institutions results in timely critical data entry into the Electronic Data Capture (EDC) system and faster response times to queries.
Re-imagine your research program with flexible, scalable support. At CRDC Solutions, we not only allow sites and institutions to focus on the patients and protocol while we focus on the data, but we offer Sponsors and CROs a safety net for not IF but WHEN issues arise. Our remote coordinators accelerate data entry, reduce data cut preparation times, and address ongoing data entry backlogs, including aging queries. Our scalable support can also help with listing reviews, IRT support, and safety reviews, and much more. We offer tremendous flexibility in customizing the support - from half-time for 6 months - to full-time for annual engagements.
We have partnered directly with long-standing recruiting companies to provide us with a large cohort of well-qualified CRDCs to meet your needs. We handle all the paperwork - sites, sponsor, CROs - agreements with proven templates and workflows. Our PMs are experts in assuring the CRDC is specifically trained for your protocols, SOPs and EDC environments. Most have previously worked at large academic institutions - so they hit the ground running!
Please send us a message or call us to connect.
CEO: Kary Inserra, CCRA, EMT
Cell: (609) 694-4294
Monday - Friday: 8:00am - 5:00pm
Saturday - Sunday: Closed
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