Directing a large technology-integrated site network, Justin Deck, Chief Clinical Officer of Tilda Research, knows “to make a mark in the clinical research space, you’ve got to do it better, smarter, and faster than everybody else.” Ram Yalamanchili, founder and CEO of Tilda also shares in this objective, “Our mission and model is to transform healthcare through innovative research.”
Tilda is a technology-focused research company. Deck and Yalamanchili understand that research is complex and that it is difficult for sites to manage operating issues, adhere to complex protocols, and stay economically viable. Adoption of technology like Electronic Health Records (EHR) integrations and Clinical Trial Management Systems (CTMS) helped Tilda reduce complexity and grow their business. However, these systems alone were not enough to achieve the digital transformation they had envisioned.
“The clinical trial industry must constantly embrace change to stay competitive,” says Deck, “and the emergence of COVID-19 is increasing the rate of this necessary change faster than anyone could anticipate.”
Success Highlights
To make a mark in the clinical research space, you’ve got to do it better, smarter, and faster than everybody else. – Ram Yalamanchili, founder and CEO
Veeva is a very well-established and trusted company. They offer many technology applications and we feel they will be an enduring presence in the industry. – Justin Deck, Chief Financial Officer
The Challenge
When Deck joined Tilda, he immediately noticed the mountains of paper building up throughout the office. “We had cubbies upon cubbies full of binders and paperwork all over the place.” Studies required full-time research assistants dedicated solely to filing, retrieving, and archiving documents. The costs of storing and accessing paper documents for a single study for up to 15 years could be up to $11,500. With over 350 active and archived studies, the administrative costs were high and were increasing as business grew.
In addition to the high costs of managing paper documents, Tilda’s operations team knew that there was valuable, untapped data within the clutter of paper. “Every study success is contingent on certain metrics being hit. We knew that if we had a metrics-driven site infrastructure, then the study lifecycle would be dramatically more efficient.”
Collecting these crucial metrics was a challenge. Tilda’s clinical staff was dependent on labor-intensive, human-driven processes. “Initially, we used spreadsheets and homegrown programs for the aggregation and reporting of metrics, but due to process limitations, we couldn’t get a full clinical picture of the trial’s progress,” noted Deck.
The Solution
To enable a metrics-driven infrastructure, reduce coordinator workload, boost transparency for their sponsors, and increase overall quality, Tilda made the decision to adopt eRegulatory software. Deck and his team evaluated many eRegulatory systems before selecting Veeva SiteVault Free.
“Functionality was essential,” says Deck. Coordinators and regulatory professionals at Tilda found the system easy to use. In addition, Tilda believed that SiteVault was the only eRegulatory system that could grow and scale with their business. “Veeva is a very well-established and trusted company. They offer many technology applications and we feel they will be an enduring presence in the industry. SiteVault Free works for us at our current stage and the integration capabilities in SiteVault Enterprise will help us scale as we grow.”
The implementation of SiteVault was simple and straightforward. “We didn’t need much handholding, but if we had a particular question, we could literally pick up the phone and talk to someone immediately,” says Deck.
The Outcome
| Faster study activation | Study start-up timelines have been reduced by up to 40% due to reduced administrative tasks and onsite visits. |
|---|---|
| Lower administrative burden | Regulatory tasks take 50% less time on average to complete. Much of this reduction is attributed to the searching and tracking capabilities of SiteVault. |
| Reduced storage costs | Tilda saves an average of $11,500 per study in office space, data access, and storage costs. |
| Faster document processing | Documents managed in SiteVault Free move from creation to signature and finalization 30% faster. |
| Improved visibility | Detailed metrics such as query response time, safety reporting status, deviation tracking, and enrollment forecasting have streamlined operations and improved visibility for sponsors. |
| Better quality | Regulatory documents have fewer errors and require fewer revisions and have allowed Tilda to deliver quality of service that exceeds customer expectations. |
Deck believes a big part of their success came from leadership’s dedication to innovation. Being a digitally enabled allowed them to grow their operations during the pandemic and support research more effectively. Capabilities around remote-based regulatory, monitoring, study startup, and execution became a key requirement for sponsors – especially when travel is restrictive.
The use of SiteVault was enforced by leadership. “All our operations staff know not to generate paper unless it is absolutely required. Nearly all of the administrative work now flows through Veeva automatically. Our team believes in the use of technology and are using it help our company to do bigger and better things,” says Deck.
Most importantly, SiteVault allows Tilda to deliver quality of service in excess of sponsor expectations. “At the end of the day, we want to spend more time with patients and help sponsors achieve the results they expect. It’s the highest level goal we have,” says Yalamanchili. “Veeva SiteVault allows us to continue to deliver the quality of service that our sponsors expect.”
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