With increased attention on decentralized clinical trials, a growing number of sponsors and CROs plan to adopt direct data capture (DDC), eCOA, ePRO, and eConsent into their workflows. Several reputable vendors offer holistic eSource solutions. But what if you want to build and operationalize studies yourself?
For many drug developers, technology solutions and support services that allow them to build their own study — with their data, their team, their way — is all they need to execute an electronic data capture strategy.
A subscription-based model that provides the flexibility to use a variety of solutions and services, from ePRO and training, to help desk and translation support, enables companies to make the most of their internal resources and outsource less. This results in greater control of data to make immediate decisions based on real-time insights.
This model allows sponsors and/or CROs to:
- Bring more clinical trial functions in house
- Increase revenue by unleashing the full capabilities of internal teams
- Bring more visibility into study build and deployment to make decisions based on real-time insights
- Rapidly configure and deploy homegrown questionnaires with activity library access
- Simplify translations by using a built-in system function
- Rapidly accelerate speed to database lock
By licensing only the technology they have a desire to bring in-house, CROs reduce operating costs. They also have the potential to win new clients by offering eSource DDC, eCOA, and ePRO as a service — without acquiring a technology company to do it.
Sponsors that want more oversight of their data can gain the visibility needed to make critical decisions in the moment. At the same time, they can gain real-time data access to take control of their study.
As a first-of-its-kind subscription model, study build, translation and licensing questions remain. Register for this webinar today to get your questions answered and learn more about how this model for efficient data capture can deliver cost-savings and efficiency gains.
Kim Romanello, Senior Director, Outcome Solutions, Clinical Ink
Kim Romanello is an expert in ePRO/eCOA standards for solution design and implementation. With more than nine years of ePRO/eCOA experience, Kim has led multiple global deployments in various indications and phases of clinical trials. She leads Clinical Ink’s solution architecture team and represents the company as a member representative in the Critical Path Institute’s ePRO Consortium. Before joining Clinical Ink, Kim led life sciences project implementations for Oracle, and managed eCOA project implementation at PHT and ERT.
Brady Keeter, Manager, Product Innovation, Clinical Ink
Brady Keeter has over 10 years of experience in healthcare technology, leading product and engineering teams through the development of patient engagement and eLearning solutions. As Manager, Product Innovation, for Clinical Ink, Brady translates product strategy into technical requirements and prototypes. She also works closely with key functional leads to ensure commercial and operational release readiness, and with engineering teams to ensure successful delivery of Clinical Ink solutions.
Who Should Attend?
This webinar will appeal to individuals with the following, or related, job titles:
- ePRO/ePRO Category/Data Managers
- Clinical Trial/Clinical Study Leads
- Clinical Operations Specialists
- Clinical Operations Directors/VPs
- Therapeutic Strategy Leads
- Biometrics/Biostats Managers
As well as senior professionals who are:
- Working in the clinical trial transparency or medical writing domain
- Responsible to produce, review and/or approve plain language summaries
- Establishing processes for PLSs
What You Will Learn
- How to increase revenue by unleashing the full capabilities of the internal teams.
- How to bring more visibility into study build and deployment to make decisions based on real-time insights
- How to simplify translations by using a built-in system function
Clinical Ink, a global clinical technology company, offers data certainty from source to submission via our Lunexis™ eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules. This suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and provides anytime, anywhere data access, saving resources as your trials progress. For more information, visit clinicalink.com.