We've all seen the headlines, haven’t we? The cost to develop a new drug ranges from less than $1 billion to more than $2 billion, protocol deviations and amendments cost $5-6 billion/year, and not a tremendous southward movement in any of these figures for the last 10 years. We are only just getting better at quantifying this reality.

However, there are several bright spots before us. First, many emerging and established companies are working to tackle these challenges and create efficiencies in the overall clinical trial operations process. Second, sponsors are paying attention. The clinical trials ecosystem is also evolving – attracting new players due to advanced innovation via significant valuation companies.

In 2021, I was commissioned by Teckro to quantify the impact of Teckro on sponsors compared with standard operations. We used data for an average study involving 250 patients, at 40 sites, over 60 months. The model is agile and can be tailored to specific sponsors and protocols.

Based on interviews, focus groups and lots of literature searches, the team and I developed a model that estimates the following cost savings per average study:

• An estimated $126,000 due to digitization of the clinical protocol, study documentation and other site communication tools; this avoids the need for design, printing, shipping of study documents and updates, while providing improved access and searchability.
• A range of $55,350 to $162,000 by minimizing protocol deviations and violations, which can put at risk the safety, rights, and welfare of subjects, compromise data integrity, delay regulatory submissions and raise cost.
• A 30% reduction ($175,000+) in resource allocation needed for site communication, inefficient site contact and administrative work; and a 10% reduction ($28,000) for medical monitors’ time.

Based on two customer scenarios, this model estimates an impact of $118,000 to $456,000 due to Teckro. This is achieved by supporting inexperienced site staff with training materials, real-time access to study-related advice and a digitized, searchable protocol. This helps minimize human error, while improving sponsor-site relationships.

Outside of the positive financial impact, I also learned sponsors are leveraging Teckro to advance corporate strategic initiatives, including supporting community-based and research-naïve sites. We have all seen the importance of boosting the size of the site pool, enabling clinical research as a care option, and improving diversity, equity, and inclusion in clinical trial populations – all while ensuring high quality and compliance. I also learned just how much sites love using Teckro. Don’t believe me? Check out these customer testimonials.

Positive value drivers for all key stakeholders

Overall, Teckro underpins faster, safer, more efficient clinical trials based on multiple positive value drivers. These include:

• For the sponsor: Visibility, more rapid information exchange and increased compliance, and improved environmental sustainability due to reduced printing and shipping activities.
• For the research site: Increased protocol compliance, positive impact on recruitment and patient safety, better organization of study material, and more efficient communication and operations.
• For the clinical research organization (CRO): Reduced protocol deviations and violations.

The important benefits of Teckro can be applied to any type of clinical trial, including the decentralized approaches that have become increasingly prevalent during the COVID-19 pandemic, helping enhance communication among stakeholders and improve sponsor visibility, even under challenging conditions.

Jeanne Hecht

Founder & CEO at JTH Consulting & Associates

Guest

Jeanne Hecht is a Global Business Executive and Board Member with deep experience leading successful teams across mature and emerging markets within the product development, pharma services and life sciences space. She is passionate about elevating business leaders and utilizing networks to drive businesses and advance medicine.