5 Key Takeaways from our webinar ‘Don’t treat your Registry Like a Clinical Trial’

A patient registry, according to the Agency for Healthcare Research and Quality, is an organized system that collects uniform data from observational studies to determine a population’s outcomes for a specific condition, disease, or exposure.

Registries have evolved significantly with the focus on patient-centric needs, integration of real world evidence, and data collection using novel research and digital tools. But unlike standard clinical trials, registries are capable of providing meaningful data and results to inform research strategy and clinical care.

Navitas Life Sciences’ Experience in Managing Registries

Navitas Clinical Research (NCR, a part of Navitas Life Sciences) has over 30 years of experience in designing and managing registries, clinical trials, medical device trials and observational studies.

COMPREHENSIVE SERVICES TO MEET ALL YOUR REGISTRY DESIGN & IMPLEMENTATION NEEDS

• Multidisciplinary team with combined therapeutic/disease specific knowledge, scientific expertise and registry operation experience
• Common Data Element (CDE) and metadata driven Registry eSolution implementation
• Development of Pilot Registry with core and focused data elements and data sets
• Creation of data collection forms
• Development of patient reported outcomes module

Our vast experience and expertise in managing registries was leveraged to conduct an insightful webinar titled ‘Don’t treat your Registry Like a Clinical Trial’. Below are some key takeaways:

Takeaway 1: Identify the main purpose: There should be a clear reason for setting up a registry and its purpose and objectives should be well-defined. This will aid in collection of high-quality data that is most relevant. When the registry’s purpose is not well defined, there is a risk of loss of focus and collection of irrelevant or poor-quality data that could affect cost and timelines.

Navitas Clinical Research’s experience in building and managing large registries for research and clinical care purposes, and capturing clinical data from Electronic Health Record (EHR) systems across a wide array of products and settings lays the foundation for collection of the best real world data.

Takeaway 2: Effective stakeholder engagement: Patients, scientists, clinicians and more are key stakeholders whose engagement is important as they are the beneficiaries of registry data. Their insights could drive improved planning for registries. Involvement from such stakeholders will help provide continuous feedback throughout the registry life cycle.

NCR knows exactly what tools to utilize to collect patient-reported outcomes in multi-site, global registries, and we have experience developing and successfully deploying registries and clinical decision support tools that are highly usable and embraced by patients, physicians and clinical researchers alike.

Takeaway 3: Finding the right registry platform: There are multiple data sources available to set up registries, so it’s important to determine which one is most suitable to support your registry data. Important aspects to consider include managing logistics, handling data elements and harmonization procedures.

NCR utilizes state of the art web-based business intelligence tools and dashboards for clinical registries allowing sponsors, clinicians, project managers, data quality specialists and drug safety personnel to explore the data, identify trends or problems and create ad hoc quantitative reports and graphics at the patient level, supporting efficient and effective decision making.

Takeaway 4: Role of the Registry Coordinating Center: A registry coordinating center is made up of personnel who support registry operations, adhering to milestones and ensuring timely deliverables. Such coordinating centers ensure that the development of the registry is compliant with all regulatory requirements, support enrollment activities, and coordinate data management activities that support the integrity of registry data.

The total addressable aspects in developing a registry All stages of the registry life cycle, from protocol development to data analysis, publications, and planning for follow-on studies, are effectively managed by a registry coordinating center, allowing organizations to deliver on promises made to Board leaders and stakeholders.

Takeaway 5: A closer look at Sustainability: A successful registry is one that it is sustainable, which is best achieved by ongoing engagement with relevant stakeholders and deploying relevant technology to achieve identified outcomes. It will also require consideration of sources of funding and the appropriate use and sharing of data.

NCR works with your foundation and patient advocates to tailor data collection instruments to your specific disease state and specific patient concerns. By leveraging significant experience in operating registry programs, NCR is able to provide expert guidance in planning for future directions and ensuring that a registry can deliver meaningful results for the long-term.

Registries offer significant benefits when they are developed with stakeholder interests in mind, working to be game changers in the health care industry. They are uniquely suited to interrogate human diseases and conditions, providing insights for both patients, clinicians, scientists and more.

You can join the Navitas Clinical Research family of highly satisfied foundations and small/medium Pharma companies, as well as several agencies of the U.S Federal Government.

To find out more about setting up registries, watch our Exclusive On-Demand Webinar

Don’t Treat Your Registry like your Clinical Trials

Listen to our On-demand webinar as our subject matter experts explore key themes regarding

• How Registries are different from Clinical Trials?
• How to effectively support the development of a Registry?
• Which systems and strategies are necessary to develop a successful Registry

Yun Lu

Chief Science & Innovation Officer
Navitas Clinical Research

Sarah Lawrence

Sr. Clinical Project Manager
Navitas Clinical Research

Andra Matthews

Senior Clinical Project Manager
Navitas Clinical Research

To know more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.