MainEDC

MainEDC™ is an eClinical solution designed for the medical research industry. It offers a suite of tools and features tailored to meet the needs of pharmaceutical companies, biotech firms, and clinical research organizations (CROs). MainEDC™ is utilized by various professionals, including data managers, data science specialists, clinical trial investigators, and researchers in the pharmaceutical industry.

Key Features

Deploy studies in days: According to the vendor, MainEDC™ allows for the quick deployment of studies, with a median First Patient In (FPI) time of 9.2 days after the start. The platform provides ready-to-use tools, templates, and best practices in data management and data science.

Save budget: The vendor claims that MainEDC™ offers cost-saving benefits, potentially saving up to 85% on a platform (EDC, ERT, eCOA) and up to 75% on clinical monitoring. The pricing model is fixed, fair, and open, aiming to provide competitive pricing.

Automate drug supply management: MainEDC™ features an automated drug supply management system, which the vendor states can significantly mitigate the risk associated with human errors. This automation is noted by 97% of customers, potentially enhancing compliance and reducing potential mistakes.

Increase knowledge and advancement: MainEDC™ offers e-training opportunities where professionals can build their first study alongside experienced data managers. The vendor claims that this feature helps increase the knowledge and advancement of data management and data science professionals, as noted by 96.6% of specialists.

Premium security level, private cloud hosting: MainEDC™ ensures a high level of security compliance, including adherence to GCP E6 R2, GAМP 5, 21 CFR Part 11, GDPR, and HIPAA standards. The platform allows for quick deployment and adjustments to protocol amendments, providing an advanced Visual Edit-checks Builder for efficient eCRF building.

MainEDC™ ePRO for capturing patient data: MainEDC™ offers an electronic patient-reported outcome (ePRO) module, providing easy access for investigators via a dedicated website. The pricing is fixed, fair, and open, allowing users to pay as they go.

Accelerated project start time: According to the vendor, MainEDC™ aims to expedite the project start time in the clinical trial industry, potentially reducing the average time of 12.7 weeks to as fast as 5 days, ensuring faster initiation of research projects.

Transfer of Competence: MainEDC™ offers a unique transfer of competence feature, allowing for the sharing of expertise in data management, data science, or drug management. This transfer is facilitated through collaboration on a specific project, offering users the optimal solution for their situation.

Transparency at every step: MainEDC™ emphasizes transparency in its approach, providing best practices, useful techniques, and knowledge sharing throughout the project. Ongoing support and analytics are available to ensure a smooth and transparent workflow.

Compliance with industry standards and regulations: MainEDC™ is fully compliant with industry standards and international regulations, including ICH GCP E6(R2), HIPAA, GDPR, 21 CFR Part 11, GAMP 5, CDISC, and MedDRA. This ensures that research is conducted in accordance with the highest standards of data integrity and privacy.