
ABOUT OPENCLINICA
OpenClinica is transforming healthcare through innovative cloud technology that simplifies running clinical trials. Proven in over 10,000 studies worldwide, the OpenClinica platform is trusted by leading biopharmaceutical companies, contract research organizations, academic institutions, and government agencies. OpenClinica is used across a wide spectrum of clinical research, including drug, device, and diagnostic trials, global health studies involving 200,000+ patients, adaptive platform trials, and clinical trials for some of the first gene therapies to be approved for market. Hundreds of small, midsize, and large research organizations leverage OpenClinica to capture better clinical data faster and to do so in a way that meets the highest standards for security and regulatory compliance (21 CFR Part 11, Annex 11, GDPR, HIPAA).
OpenClinica, LLC is headquartered in Waltham, MA. For more information on OpenClinica’s solutions for electronic data capture (EDC), eSource, eCOA/ePRO, randomization, and analytics & reporting – visit www.openclinica.com.
CONTACT INFORMATION
OpenClinica
1075 Main Street Suite #140
Waltham, MA 02451
UNITED STATES
Phone: 215-760-4294
Contact: Mary Lou McCoy
HOT PRODUCTS
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Discover why more life science teams are using OpenClinica Unite™ to automate source data acquisition from patient medical record systems to clinical trial research databases and case report forms.
FEATURED ARTICLES
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Discover how to maximize the potential of eSource Electronic Health Records (EHR) integration in clinical trials to benefit sites, sponsors, clinical trial researchers, and patients.
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Dive into the key advantages of using electronic informed consent (eICF) in clinical trials and the reasons why researchers are increasingly opting for modern digital technology.
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During DIA 2023, SMART on FHIR and its promising future sparked numerous inquiries from media, clients, prospects, and industry leaders alike, prompting CEO Cal Collins to provide helpful insight.
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Get an overview of SMART on Fast Healthcare Interoperability (FHIR) for clinical trials, including workflow improvements, real-world data (RWD) integration, and reducing researcher burnout.
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While historically challenging, unearth the ways studies can enhance patient enrollment, consent, engagement, and clinician satisfaction.
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Touted as one of the more challenging aspects of clinical trials, discover how patient enrollment and retention can experience better outcomes when patient considerations are placed at the forefront of a study.
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In clinical research, change can take many forms, making it essential for teams to be ready to adapt at a moment’s notice. Stay ahead of the curve and master change management with these tips.
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The key to recruiting and retaining participants in clinical trials is patient engagement. Discover how digital tools can help to open the “digital front door” to clinical trials and make them more accessible to participants.
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Read about the benefits of automated data capture for clinical trial researchers and how teams are getting the help they need amidst added pandemic and protocol stress.
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Learn how the built technology was able to eliminate expenses and errors associated with the manual abstraction of electronic health record data into clinical trial research databases, and case report forms.
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Discover how sponsors are turning to innovative solutions that deliver electronic health records to electronic data capture integration to automate documentation and improve site relationships.
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The need to manage change in clinical trials is unavoidable. Learn how to best plan for change related to the most critical element of trials – the data to support a therapy submission – can save substantial time, money and resources.
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There are plenty of ways to randomize the order of options in clinical trial design. You could, as many do, create multiple code lists containing the same options in a different order. But there is a more efficient way.
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Data managers invest a lot of time and attention documenting lab processes, and for good reasons. Also, ensuring the validity and clinical significance of lab results is critical to assessing safety and efficacy. While necessary, this process is often inefficient and error-prone.
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Data managers spend so much time reviewing submitted data for reasonableness and consistency. What if it were possible to guard against introducing error in the first place? With electronic forms, it is possible.
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Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.
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In this blog, see how each decentralized clinical trial is unique and has its own set of requirements. Based on your trial’s design, consider how to plan for necessary system interactions, leverage the data collected, and select the right partner.
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When running any clinical trial–decentralized, virtual, hybrid, or site-based–there are tools that capture better data faster without sacrificing data quality. One of your most valuable tools will be an Electronic Data Capture (EDC) platform. Access this checklist to discover EDC must-haves during your next clinical trial.
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Most of us rely on electronic data capture (EDC) to help us reach our study destination. How do we choose the EDC "vehicle" that will get us there safely, with minimal delays? Consider the relative importance of these key EDC features.
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Data capture entries, when left unresolved, not only create more work for monitors and coordinators, but delay interim and final locks.