It’s not inexpensive to develop a new drug or medical device. In 2016, bio/pharma companies spent approximately $127 billion on research and development. By 2020, R&D expenditures are estimated at $148 billion globally, according to PharmSource Information Services, a leading research and news outlet.
Given the significant size of R&D investments, it’s important to ask: Are you making the most of your EDC Investment?
To provide an answer to that question, OmniComm Systems recently launched a new service. EDC CARE is a comprehensive TrialMaster® qualification program that uses a consultative approach to evaluate a customer’s readiness for building, administering and supporting studies in TrialMaster EDC utilizing advanced techniques and industry best practices to optimize efficiency throughout the study design and execution process.
Meredith Bell, OmniComm’s clinical solutions consultant and program lead for EDC CARE, spoke with our social media team recently. Below is an excerpt from that conversation and information about our free webinar: Maximizing the Value of Your EDC Investment.
Tell us a little about yourself.
I’ve worked in the clinical trials industry for 15 years, starting my career as an onsite clinical research coordinator. Back then, we didn’t have a favorite EDC platform, we had a favorite pen to complete our paper casebooks! Now I work with the Professional Services team at OmniComm, where I use my diverse knowledge to help our customers create a better clinical trial experience for their sites and patients.
What is EDC CARE?
EDC CARE is short for Cultivating Adoption, Readiness and Expertise in electronic data capture. EDC CARE extends OmniComm’s existing Enterprise Enablement service that already enables customers to fully leverage our software through immersive, hands-on training from TrialMaster experts.
When designing a qualification program for TrialMaster users, our goal was to supplement the training with a battery of collaborative exercises that extends beyond technical proficiency. Once EDC CARE-Qualified, customers are better positioned to reduce operational expenses, streamline data management activities and shorten study-development timelines.
What makes EDC CARE different from other qualification programs?
The majority of EDC providers focus solely on technical proficiency when it comes to obtaining certification. While technical proficiency is indeed essential, research suggests that the growing emphasis on implementing technology innovations to support clinical operations relies heavily on an organization’s ability to effectively manage change as well. A 2014 article in Implementation Science identifies two key factors associated with determining success in new technology implementations:
- Individual structure – the knowledge, skills and ability to perform the required tasks.
- Organizational structure – personnel, material resources, communication and formalized procedures (Khan et al.; 2014)†.
For this reason, EDC CARE extends proficiency evaluations beyond the skills obtained through traditional instructor-led training and delves deeper to help our EDC CARE-Qualified customers optimize organizational efficiency, while also providing them with an opportunity to become expert study builders in a leading technology.
Who should consider participating in the EDC CARE program?
EDC CARE offers the opportunity for customers at all skill levels to gain expert knowledge. This program is perfect for: 1) lean organizations looking for a way to optimize limited resources, 2) data management teams who want to identify and eliminate potential gaps in processes, and 3) experienced CROs who simply want to increase their organization’s marketability to potential customers by expanding their portfolio of technical expertise.
How did OmniComm’s corporate culture inspire or shape your work on this program?
It’s apparent to me that OmniComm truly cares about its employees, and this empowers us to extend the same care and respect to our customers. So, when tasked with creating a qualification program for our customers who are adopting TrialMaster within their own organizations, incorporating the concept of “care” somewhere in this program was an obvious decision. I also wanted this program to reflect the high level of collaboration OmniComm fosters with our customers, so EDC CARE is designed to be flexible and attentive to each customer’s unique needs.
About the Contributor
Meredith Bell is a clinical solutions consultant with the OmniComm Professional Services team. Her passion lies in improving human health by innovating a better clinical trial experience for sites and patients. Meredith’s professional experience centers around leading the design, development, launch and marketing of novel technology and business solutions. Prior to joining OmniComm, she served as the clinical systems product manager and lead business subject matter expert for the central laboratory division of Q2 Solutions (formerly Quintiles Laboratories).
About OmniComm Systems, Inc.
OmniComm Systems, Inc. (OTCQX: OMCM), is a leading strategic software solutions provider to the life sciences industry.
†Khan, S., Timmings, C., Moore, J.E., Marquez, C., Pyka, K., Gheiman, G. & Straus, S.E. (2014). The development of an online decision support tool for organization readiness for change. Implementation Science, 9:56. Retrieved from http://implementationscience.biomedcentral.com/articles/10.1186/1748-5908-9-56