As Contract Research Organizations (CROs) experience growth and success, expansion of service offerings can be a logical step in their continued support of their clients’ needs. Topstone Research, a CRO based in Toronto, Ontario, Canada and founded in 2012, knew that they were ready to add to their arsenal of services in early 2016.
While Topstone initially offered Clinical Monitoring, Project Management, Drug Safety, Quality Assurance, and Medical Monitoring, their long-term vision had always been to become a full-service CRO. In April 2016, the team decided to start setting things in motion to bring data management in-house, further developing their package of specialized clinical trial management services. Topstone quickly recognized that they had to find the right eClinical tools, not only to support the development of their new data management infrastructure, but to meet the demands of ongoing clinical trials with limited time and resources.
• Tasked with developing in-house Data Management infrastructure from scratch
• Took over multiple ongoing clinical trials
• Needed efficient EDC with easy setup
• Introduced to Medrio and decided to implement Medrio at Topstone
• Immediately found Medrio straightforward and user-friendly
• Impressed by bulk upload feature, integration capability, absence of programming requirement, and more
• Ultimately reduced study build to under 5 weeks, beating industry standard
• Managed multiple simultaneous demands with ease
• Able to run clinical trials smoothly across all study phases
Prior to bringing data management in-house, Topstone’s data management services were provided by a third-party vendor. For this reason, Topstone’s executive management had to start from scratch in developing their own data management team. They hired Bilal Muhammad to build out Topstone’s entire data management infrastructure, from developing SOPs to hiring multiple data managers. Additionally, Bilal was responsible for evaluating and determining which EDC system the new team would utilize.
“The system is easy to use. Someone with very little background knowledge in EDC and programming could be trained and start building studies quickly and efficiently.” – Bilal Muhammad
Having worked at various organizations in the clinical research industry, Bilal was familiar with several EDC systems. As he got involved in the ongoing studies previously handled by Topstone’s data management provider, he was introduced to Medrio, as this was their system of choice for multiple trials. Bilal’s initial impressions of Medrio were that the system is straightforward and user-friendly. “The system is easy to use. Someone with very little background knowledge in EDC and programming could be trained and start building studies quickly and efficiently,” Bilal explained.
The more Bilal dove into the system, the more he recognized that for various reasons, Medrio was an ideal system for a boutique CRO establishing in-house data management for the first time, a significant differentiator being the ease of study setup. The ability to set up the system easily without any programming expertise was especially crucial for him as he searched for data managers to join his team, as many may not have the programming background that is often required to successfully navigate other EDC platforms.
Beyond Medrio’s user-friendly interface, which does not require programming skills to navigate, there were numerous other features that enabled the new, developing data management team to manage their heavy workload, which included a rescue study requiring the import of thousands of previously collected records.
• Bulk Upload: This was critical for the rescue study, which had over 20,000 records of legacy data, over 10,000 of which needed to be uploaded to Medrio from the sponsor’s prior EDC.
• Bulk Import and Data Upload: Topstone deemed these essential to successfully uploading the old data into the new system and keeping trial operations running smoothly.
• Integration: Topstone has used Medrio’s application programming interfaces (API) to integrate Medrio with their chosen IRT, saving time and money.
“As we started data management in-house, Medrio was the perfect system for me and my team. We can run phase I-IV trials without any issue and it is a very successful system for data management execution.” – Bilal Muhammad
Topstone was able to get their first study set up with Medrio in five weeks, much faster than the industry standard of six to ten weeks for study startup. After completing some product training and accumulating more study build experience, Topstone was able to shorten that timeline to less than five weeks with their third study. More importantly, Bilal was able to balance numerous demanding tasks, from setting up the entire infrastructure of Topstone’s new data management team, including creating their SOPs, to interviewing and hiring data managers and building and managing multiple concurrent studies with Medrio. “As we started data management in-house, this was the perfect system for me and my team,” Bilal stated. “We can run Phase I-IV trials without any issue and it is a very successful system for data management execution.”
The simplicity and efficiency of Medrio allowed Bilal to offset the demands and complexities of his workload. “Building out an in-house data management team is a major project; doing so while in the midst of several ongoing studies is even more demanding,” commented Mike Novotny, founder and CEO of Medrio. “I’m proud that Medrio’s software was simple and intuitive enough to facilitate this process without adding any complexities or delays.”
About Topstone Research
Topstone Research is a full-service contract research organization (CRO) with an unwavering commitment to quality and service flexibility. It specializes in providing outstanding CRO services from protocol development to clinical study reports and beyond, with customized clients’ requirements and executed with well-designed workflow processes and procedures. Topstone’s studies follow ICH, GCP, and regulatory agency guidelines, and use controlled and secure computing environments with validated, 21 CFR Part 11-compliant software and systems. Their teams of experts can provide unique insights into the research environment, competitive landscape, and patient populations of a variety of therapeutic areas. And those teams support clients’ drug development needs by providing real-time, faster access to data, enabling them to make faster decisions and get their drugs to the market as quickly as possible, all while making patient safety a top priority. For more information, please visit www.topstoneresearch.com.
Founded in 2005, Medrio is a leading healthcare technology company that provides eClinical solutions including EDC and eSource for clinical trials. The company’s cloud-based software platform and mobile suite of products deliver fast, flexible, and easy-to-use tools for study sponsors and contract research organizations (CROs) that accelerate the collection of clinical trial data 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 the UK and India. For more information, please visit www.medrio.com.