MasterControl
MasterControl provides a unified manufacturing and quality management software platform to help life sciences companies deliver safer, more effective products to patients faster and more reliably.
Medidata Rave EDC
Medidata Rave EDC is a clinical data management platform that captures and manages patient data for global clinical trials while ensuring regulatory compliance and data integrity.
Quick Comparison
| Feature | MasterControl | Medidata Rave EDC |
|---|---|---|
| Website | mastercontrol.com | medidata.com |
| Pricing Model | Custom | Custom |
| Starting Price | Custom Pricing | Custom Pricing |
| FREE Trial | ✘ No free trial | ✘ No free trial |
| Free Plan | ✘ No free plan | ✘ No free plan |
| Product Demo | ✓ Request demo here | ✓ Request demo here |
| Deployment | ||
| Integrations | ||
| Target Users | ||
| Target Industries | ||
| Customer Count | 0 | 0 |
| Founded Year | 1993 | 1999 |
| Headquarters | Salt Lake City, USA | New York, USA |
Overview
MasterControl
MasterControl helps you bridge the gap between quality and manufacturing by digitizing your entire product lifecycle. You can eliminate paper-based processes and manual data entry, which reduces the risk of human error and ensures you stay compliant with rigorous FDA and ISO standards. The platform connects your documents, training records, and quality events in a single location so your team always works from the most current information.
You can accelerate your production timelines by using digital production records that catch errors in real-time rather than after a batch is completed. Whether you are a growing biotech startup or a global pharmaceutical leader, the software scales to meet your specific regulatory needs. By integrating quality directly into the manufacturing process, you can focus more on innovation and less on administrative paperwork.
Medidata Rave EDC
Medidata Rave EDC serves as the central hub for your clinical trial data, allowing you to capture, manage, and report on patient information with high precision. You can streamline the entire data entry process for site coordinators while maintaining strict adherence to global regulatory standards. The platform eliminates manual paper-based tracking by providing a unified environment where clinical teams can monitor study progress and data quality in real-time.
You can scale your research from small Phase I studies to massive global Phase III trials without switching systems. The software helps you reduce study build times and improve data visibility across your entire research portfolio. It is primarily used by pharmaceutical companies, contract research organizations (CROs), and medical device manufacturers who need a secure, validated environment for complex clinical research data.
Overview
MasterControl Features
- Document Control Automate your entire document lifecycle from routing and escalation to approval and archiving in a secure, centralized system.
- Training Management Automate the assignment and monitoring of training tasks to ensure your personnel are always compliant with current SOPs.
- CAPA Automation Integrate your corrective and preventive actions with the rest of your quality system to identify and resolve issues faster.
- Audit Management Streamline your internal and external audit processes with automated scheduling, customizable checklists, and real-time tracking of findings.
- Change Control Manage changes to processes or products with a structured workflow that ensures all stakeholders review and approve modifications.
- Digital Production Records Replace paper batch records with digital versions that validate data entry in real-time to prevent production errors.
Medidata Rave EDC Features
- Unified Data Capture. Capture all your clinical trial data in one place to eliminate silos and ensure a single source of truth.
- Real-time Data Validation. Identify and resolve data discrepancies immediately with automated edit checks that fire as soon as you enter information.
- Flexible Study Build. Build your electronic case report forms once and reuse them across multiple studies to accelerate your trial timelines.
- Medical Coding. Code your adverse events and medications quickly using integrated dictionaries like MedDRA and WHODrug for consistent reporting.
- Targeted SDV. Reduce your monitoring workload by focusing Source Data Verification only on the most critical data points and high-risk sites.
- Global Library Management. Standardize your data collection across all global sites by managing a central library of validated forms and folders.
Pricing Comparison
MasterControl Pricing
Medidata Rave EDC Pricing
Pros & Cons
MasterControl
Pros
- Simplifies complex regulatory compliance for FDA and ISO
- Centralizes all quality documents in one searchable location
- Automates repetitive follow-ups for training and tasks
- Strong audit trail capabilities for high-stakes environments
Cons
- Initial configuration requires significant time and effort
- Interface can feel overwhelming for occasional users
- System performance can lag with very large datasets
Medidata Rave EDC
Pros
- Highly scalable for large global clinical trials
- Gold standard for regulatory compliance and security
- Extensive integration with other Medidata clinical products
- Robust reporting capabilities for monitoring study progress
Cons
- Requires specialized training for study builders
- Initial setup and configuration can be time-consuming
- Higher price point compared to basic EDC tools