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.

VIDEOS

  • Listen as OpenClinica Co-Founder and COO, Ben Baumann, discusses how our newest solution OpenClinica Unite™ makes it easy for sites to enroll patients into their clinical trials right from within their EHR.

  • Listen as OpenClinica's Co-Founder and COO, Ben Baumann discusses how their newest solution OpenClinica Unite makes it easy for sites to enroll patients into their clinical trials right from within their EHR.

  • Featured in the televised "In Depth" educational series, OpenClinica spotlights electronic data capture (EDC) eClinical systems and their role in ensuring high-quality, statistically sound data.

  • Rajeshwari Jakkam, Senior Solutions Consultant, demonstrates how image maps can increase speed and precision for physicians & researchers by enabling precise, visual selection of breast lesion locations.

  • At OpenClinica, our goal is to provide you with Better Data, Faster. Hear firsthand how our Senior Solutions Consultant, Galen Tran, has experienced building initial studies more than a week faster with OpenClinica’s solution suite, compared to other EDCs.

  • Quality and compliance go hand-in-hand. Hear Chief Executive Officer, Cal Collins, describe OpenClinica's dedication to ensuring that in every decision we make, compliance and quality are always considered first and foremost.

  • With easy to build CRFs, checks to determine patient eligibility, and multi-randomization options, OpenClinica Randomize can help you save time integrating randomization into your study workflow. Because randomization workflows should, well, flow.

  • Make the complex easy by providing better data, faster. In our latest video installment, hear Justine Pierson explain the easily configured & flexible aspects of our solution suite that simplifies the complexity of managing any study.

  • Clinical Data Managers play a critical role in the success of a trial. In this latest video CDM, Justine Pierson, shares why OpenClinica was the right solution for streamlining her heavy workload.

CONTACT INFORMATION

OpenClinica

1075 Main Street Suite #140

Waltham, MA 02451

UNITED STATES

Phone: 215-760-4294

Contact: Jackie Brusch

FEATURED ARTICLES

  • Learn why planning for change related to the data to support the therapy submission, can save substantial time, money, and resources in the short and long run.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • In this blog learn how data capture entries, when left unresolved, not only create more work for monitors and coordinators, but delay interim and final locks.

  • OpenClinica recently announced the launch of its electronic health record (EHR) eSource solution, OpenClinica Unite. Learn how Unite makes it easy for research teams to instantly obtain the data already sitting in the site’s EHR that is needed for the study protocol.

  • It’s easy to overlook the effects a survey’s format can have on responses, but those effects are potent sources of bias. Modern EDC allows you to systematically vary both question and response option order. This practice, called counterbalancing, guards against unwanted order effects.

  • Clinical data managers spend their careers ensuring the accuracy and integrity of clinical trial data. It’s a bit ironic, then, that perhaps the most important CDM test is one that is supposed to fail.

  • In the second part of this blog series, explore the ways to access clinical data resources even if you are not a data scientist.

  • This blog posts explains how "data science" can be inconsistent with terminology and navigates the answers to the following questions: Is a given example best characterized as data science, or data analytics, or perhaps business intelligence? Do you need a data visualization expert?

  • You’ve just been handed a protocol and asked to build it out in your EDC system. How can you make sure that the protocol is implemented in a way that maximizes efficiency and data quality? Learn how in the available white paper.

  • In this blog, walk through some of the terms that need to be known before embarking on the design of an electronic case report form (eCRF).

  • Clinical Data Managers sit at the intersection of busy information highways in clinical trials, but they do more than just direct traffic. Learn how this information can be managed in this Q&A with Justine Pierson, a battle-tested clinical data manager.