Case Study

Taking On Both Animal Health And Human Clinical Trials With One eClinical Platform

Global Data

A Broader Scope

  • CRO offering data management and statistics services
  • Specializing in Animal Health clinical trials, with recent expansion into Human Health
  • Staff bring extensive experience in both Human and Animal Health trials across data management and statistics

Why Medrio?

  • Multiple-subject data entry creates ease and efficiency
  • Granular audit trail helps with compliance
  • Medrio Partner Program increases market exposure to potential clients

Success for ClinData

  • Moved from final protocol to first data entry in just 5 days
  • Gained extra efficiency through ability to copy databases
  • Compliant with both Animal and Human regulatory authorities (e.g. CVM and FDA)

Background

ClinData International, a South Africa-based CRO specializing in Animal Health clinical trials, has used Medrio EDC since 2013. They recently joined the Medrio Partner Program, which offers business and training benefits to qualifying CRO customers, as they continue to expand into Human Health studies. Jaco Kasselman, Associate Director of Data Operations at ClinData, recently explained how organizations conducting both Human and Animal Health trials can enhance their clinical and business operations through the functionality of the Medrio system and the Partner Program.

A broader scope

“We’ve spent the last several years focusing on Animal Health and getting our data management resources in place to take on human studies as well.”

 

Jaco Kasselman, Associate Director of Data Operations, ClinData

ClinData’s continued expansion into Human Health clinical trials does not signify completely new territory for them. When it was originally founded, ClinData focused on pharmaceutical studies in humans, and built significant data management experience in this area. The company was eventually acquired, after which their headcount grew to over 500. It was only in 2012, after their CEO used the still-registered ClinData name to restart the company, that they turned their attention to Animal Health. In the subsequent years, they built a strong track record of success in Animal Health studies, serving a wide array of sponsor clients.

Their success in Animal Health, combined with their prior experience in pharma, place ClinData in a strong position to expand their services to the Human health sector. Much of their senior staff date back to the early days of the organization and bring over a decade of experience in human clinical trials. “We have a vast amount of knowledge in the human health sector,” explains Mr. Kasselman. “We’ve spent the last several years since the company was restarted focusing on Animal Health and getting our data management resources in place to take on human studies as well.”

Why Medrio?

“Multiple-subject data entry has been the main deciding factor in us using Medrio.”

 

Jaco Kasselman, Associate Director of Data Operations, ClinData

ClinData would now need an EDC solution that could assist in their expansion and has deemed Medrio an ideal fit for this task for numerous reasons. One is the versatility of the system. Over the past several years, they’ve found Medrio to be a highly effective solution to the specific challenges and data management needs of the Animal Health sector. In particular, Medrio’s multiple-subject data entry tool has been a major source of efficiency for their Animal Health studies. “Multiple-subject data entry has been the main deciding factor in us using Medrio, and staying with Medrio,” says Mr. Kasselman. “We haven’t seen other software tools that enable us to enter data like in a lab environment, just going from bed to bed or animal to animal and capturing the data we need. That makes life a lot easier for our team.” After Mr. Kasselman determined that the system was equally effective for human health studies - the team finds particular value, from a compliance perspective, in Medrio’s granular audit trail - it became clear that Medrio would serve as a one-stop shop for a company conducting both Animal Health and human clinical trials. This versatility and simplicity will be a major asset for ClinData as they broaden their services.

Another essential resource for ClinData will be more administrative in nature. By joining the Medrio Partner Program, the team will have access to marketing and business development benefits that will significantly broaden their market exposure and better position them to network with potential sponsor clients. Through priority co-marketing initiatives and other benefits, ClinData will accelerate their expansion into human studies by complementing their robust data management apparatus with stronger operations on the business side. “The Partner Program empowers us to increase our market exposure to companies looking for a data management and stats vendor,” says Mr. Kasselman. “And this is essential to our expansion.”

Success in both Animal Health and human studies

“Everything is as the sponsor needs. Getting everything standard and validated up front really helps us reduce study setup times.”

 

Jaco Kasselman, Associate Director of Data Operations, ClinData

In the years they’ve spent as Medrio users, ClinData has achieved a lot in the way of making their processes more efficient and reducing their study timelines. The ability to copy databases from previous studies and simply remove forms and make other revisions as needed has empowered them to significantly reduce their build timelines when starting new studies. As a result, their data management team has regularly been able to get their databases from final protocol to first data entry in just five days. This efficiency, combined with the high quality of their data, has gone a long way toward ensuring client satisfaction. “Everything is as the sponsor needs,” says Mr. Kasselman. “Getting everything standard and validated up front really helps us reduce study setup times.”

Looking forward, Medrio will be a major asset for ClinData from a regulatory perspective as they move into human clinical trials. The transition constitutes a major regulatory shift for the company - with human studies in their pipeline, they’ll now be accountable not just to the Center for Veterinary Medicine, but to the FDA as well. “We want to ensure that when we deal with the FDA, we have a top-tier data management tool specifically designed for clinical trials, as opposed to something like Excel,” says Mr. Kasselman.

With a one-stop-shop solution for their data management needs, ClinData is ready to pursue the same success in human clinical trials that they’ve had in the Animal Health sector. As Mr. Kasselman says: “We’re very excited to go back to the human health sector, where our original experience really lies.”

About Medrio
Medrio is a leading healthcare technology company providing eClinical solutions including EDC, eSource, and ePRO for clinical research. Founded in 2005, the company's cloud-based software platform and mobile suite of products deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively across drug, device, diagnostic, and animal health trials.  Medrio has extensive experience in all study phases and leads the market in early-phase trials.  The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations.  For more information, please visit www.medrio.com

About ClinData International
Founded in 2012, ClinData is a global CRO serving global customers with a team of engaged, passionate, knowledgeable and talented employees. We specialize in data management, CDISC SDTM and ADAM, statistical output generation and biostatistics. We provide quality, standardized, lean, compliant, innovative and value-added pharmaceutical service solutions for human and veterinary studies. ClinData has extensive experience in all study phases and pride ourselves in making the pharmaceutical research process as lean as possible and to develop standard, repeatable processes to deliver consistent, high-quality, cost-effective solutions appropriately addressing customer needs and industry changes.