Late-phase studies are growing! And they are doing so by almost every metric: size, complexity, popularity, and simply the number of studies. However, they are not growing because they are easy to implement! Indeed, recruiting a representative sample for such studies typically globalizes the project, creating many challenges, such as navigating different languages, regulatory environments, social healthcare systems, third-party vendors, etc. Additionally, some investigators may have no prior experience in clinical research or the processes and technology involved. Thus, when preparing to start a late-phase study, sponsors must begin by making some long-term decisions about their organization and study management tools – particularly regarding e-Clinical technology. These tools need to be user-friendly (for both patients and research staff), efficient across several modalities of data collection (safety, efficacy, outcomes, quality of life, etc.), compliant with multiple regulatory agencies, able to integrate with external systems, and obviously – worth their cost.
Why Viedoc when it comes to late-phase trials
An EDC system is essential for collecting and managing the ”big data” generated by large, late-phase trials across different countries and many sites. The below table summarizes the essential characteristics and requirements in late-phase studies and how Viedoc is the right tool for the job:
| Characteristic / Requirement | Viedoc | |
|---|---|---|
| Robustness, scale, globalization | Viedoc is used extensively and successfully in late-phase research globally. The system language is currently translated into 14 languages and additional languages can easily be added upon request. The eSource tool, ViedocMe, can be translated into any language. | |
| Regulatory Compliance | Viedoc is compliant with all major regulatory agencies, e.g. GDPR, FDA 21 CFR Part 11, ICH GCP, GAMP 5, HIPAA, APPI (Japan), PI-Specification (China). Moreover, our QA department plays a leading role in the eClinical Forum – an industry group which consolidates regulatory requirements from all over the world. Thus, Viedoc is “in the know” when it comes to best practices for clinical research – from global to local levels. | |
| User-friendliness / Usability | Viedoc has an intuitive and modern interface that is as good-looking as it is functional. It’s designed with the user in mind – both easy to understand and use. | |
| Training / eLearning | Viedoc’s eLearning contains step-by-step instructions, video tutorials, use-cases, training sites, and even prototype “sandboxes” for the study builders. | |
| Flexibility for complex protocols and amendments | Via a drag-and-drop interface and simple programming functions, Viedoc allows study builders to easily design an eCRF at any level of complexity. Even after the study is live, the eCRF can be updated with whatever changes are necessary. | |
| Integration-friendly | The Viedoc API facilitates the communication between external systems and the eCRF. Data can be pushed in or pulled out, as needed. Typical uses are for a Clinical Trial Management Systems (CTMS), an external system for Risk-Based Monitoring, a tracking system for drug supplies and payments, central laboratories, etc. | |
| eSource / Patient device | ViedocMe is the “app” for the patients to use to submit QoL data or any other data you want to collect directly from the patients. Add reminders (SMS and/or email) to ensure and increase compliance. Everything is translated to the local language of the patient. | |
| Clinical monitoring | Viedoc allows full visibility and control over the data collection process. A variety of queries and alerts can be raised on questionable or important data. Built-in graphical metrics and 24/7 access to data export provides a constant and thorough overview of the study. | |
| Support | Through Viedoc Admin, the Sponsor or CRO can supervise and control study access and provide first-class site support sites and users. For advanced issues, our in-house specialists will assist from our offices in Europe, China, or Japan. | |
| Randomization | Viedoc’s inbuilt randomization feature allows for both static and dynamic randomization of any complexity. Single kit assignments are also possible. | |
| Cost | Viedoc is a premium EDC available at a significantly lower price than competing products. Viedoc is priced to match the complexity of the study and no license fees are billed until the first patient is enrolled. |
"Data capturing has been made easy because of viedoc, it is incredibly robust and easy to navigate"