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FDA Launches Crackdown on Deceptive Drug Advertising
FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.
During clinical trials, data quality and study efficiency are of the utmost importance. Electronic Data Capture (EDC) software helps sponsors collect trial data and manage processes including patient form design, medical coding, and source data verification. Prior to EDC, clinical trial data was documented on 3- part NCR paper, which was liable to various pain points. Data captured incorrectly at the source, forms delayed in transit, and inefficiency in back-and-forth communication were just a few challenges that sponsors faced. Nowadays, life sciences organizations typically capture data electronically at the source (“e-source”) or transcribe paper forms into an EDC system.
A well-designed centralized EDC supports global libraries, enabling reuse of data across studies. With an intuitive, user-friendly interface, data managers may create and review studies as soon as the protocol is approved. Protocol amendments may be implemented with no system downtime thanks to advanced tools.
As pipeline grows, so does the complexity and number of trials. While legacy EDC relies heavily on custom functions and external data verification checks, modern EDC systems offer built-in form edit checks and direct data entry to significantly reduce source data verification efforts. EDC reporting capabilities and search filters allow Sponsors, Sites and CROs to quickly assess study progress. Many EDC solutions can even be configured to effectively accommodate studies across different therapeutic areas.
Many vendors enable integrations to connect EDC with CTMS, safety databases, RTSM, and ePRO to establish a single source of truth. Not only can EDC absorb data from a large range of sources, but it also allows repurpose of this data downstream. Trial processes are simplified; once researchers log in with secure credentials and fill out the relevant eCRF, sponsors may review study progress in real time. With a centralized platform, protocol violations and out-of-range values are addressed before they influence the outcome of the study.
Sponsors often consider whether to take an EDC in-house or partner with a CRO. While this decision depends on the unique Sponsor and study, here are general benefits of each operational model.
Sponsors, contract research organizations (CRO), and sites play critical roles in clinical data collection. Common EDC roles include:
Partner with ProPharma to optimize your clinical trials using their advanced Electronic Data Capture (EDC) solutions. Leverage ProPharma's expertise to ensure seamless data management, enhance study efficiency, and improve data quality with their comprehensive EDC support. Contact ProPharma today to elevate your clinical data capture processes and drive successful trial outcomes.
It’s critical that EDC solutions provide features that streamline processes for each user group. There are numerous EDC vendors in the life sciences space, all of which generally provide study build tools, customizable eCRFs, and data analytics. Below, we’ve listed some solutions that our clients use.
Medrio's user-friendly, scalable, and cloud-based solution offers reusable templates to build studies faster.
Medrio's user-friendly, scalable, and cloud-based solution offers reusable templates to build studies faster.
Read LessOpenClinica enables randomization from directly within eCRFs, mobile-friendly interface, intelligent reporting, and data import via batch upload or API.
OpenClinica enables randomization from directly within eCRFs, mobile-friendly interface, intelligent reporting, and data import via batch upload or API.
Read LessWith 30,000+ clinical trials ran, Rave EDC is a cornerstone of the Medidata Platform. It unifies key features such as Rave Coder for medical coding, Rave Safety...
Read MoreWith 30,000+ clinical trials ran, Rave EDC is a cornerstone of the Medidata Platform. It unifies key features such as Rave Coder for medical coding, Rave Safety Gateway for ICH E2B format transmission, and Medidata TSDV for clinical monitoring.
Read LessAdopted by 100+ organizations, Vault EDC can consolidate with other applications in the Vault Clinical Operations Suite: CDB, CTMS, RTSM, ePRO, and Payments to improve the...
Read MoreAdopted by 100+ organizations, Vault EDC can consolidate with other applications in the Vault Clinical Operations Suite: CDB, CTMS, RTSM, ePRO, and Payments to improve the clinical trial process. Explore ProPharma's Veeva Vault Support Capabilities.
Read LessZelta’s key features include data integration, query management, study-level reporting, and monitoring tools that are tailored towards both CROs and Sponsors.
Zelta’s key features include data integration, query management, study-level reporting, and monitoring tools that are tailored towards both CROs and Sponsors.
Read LessBefore contacting vendors, it’s important to collect the following information about your organization:
EDC solutions are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if CTMS integration and no coding are requirements, confirm that potential vendors will support those needs.
EDC systems should be viewed as an investment. Licensing, system support, and subscription fees may be continuing costs that should be compared against your department’s budget. Consider how pricing may change as you build more studies and add system users.
Consider each vendor’s proposed implementation timeline against the time constraints of your company. If a critical study is starting in eight weeks, narrow consideration down to vendors who can complete the project in that timeframe.
Purchasing an EDC is an investment not only of money, but also of time and effort. How much training will your staff need to learn the system properly? Additionally, factor in your team’s adaptability and buy-in when selecting a particular solution.
Does the EDC software meet all requirements imposed by HIPAA, GDPR, and 21 CFR Part 11? Assess the vendor’s agility in releasing new features to support evolving regulations.
ProPharma's R&D Technology team understands the criticality of selecting the right CTMS and excels in aligning your companies’ needs with regulations and GxP system best practices. Our comprehensive approach and expert knowledge ensure that your organization is set up for long-term success. Our team has extensive experience in the following areas:
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Strategy & Business Process Optimization |
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Clinical Research Solutions |
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Implementation Support |
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Validation |
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Managed Services |
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EDC Study Build and Edit Check Programming |
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If you are interested in implementing or optimizing your EDC system, ProPharma's R&D Technology team comprises experienced consultants who can advise your digital transformation. If you are interested in partnering with ProPharma on any of the services above, contact us via the form below. We look forward to working with you!
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