Clinical Trial Process Platform
The Clinical Trial Process Platform is the underlying process-based foundation of the TranSenda Central® system of integrated modular clinical trial applications. This powerful platform contains much of the common functionality utilized by each of TranSenda's solutions – helping companies engaged in clinical trials take control of their trials by managing them more efficiently and realizing the following benefits:
- Faster time-to-market
- Better compliance with both internal and external regulations
- Integration and exchange of data with disparate systems such as EDC, Document Management, IVRS, and Pharmacovigilance systems
- Enhanced visibility for proactive decision-making
- Reduction in errors
- Better resource allocation
The Clinical Trial Process Platform's open standards architecture, based upon Microsoft's .NET technology, allows our applications to integrate with legacy systems and other solutions in the TranSenda Central system. The platform allows for the exchange and presentation of data from multiple systems to internal and external users in real-time utilizing industry standards such as CDISC or other XML-based conventions. Maximum interoperability is maintained through links to outside third-party applications or databases for complete end-to-end trial management.
Because all solutions are built upon the Clinical Trial Process Platform, the solutions inherit characteristics that impart extraordinary manageability and maximum scalability. By utilizing applications built upon the platform, business logic and workflow can be applied to create universal exchange and presentation of data from multiple systems to internal users and sponsors in real-time. Our no-code-required™ technology enables unprecedented process control, allowing efficient creation and modification of workflow to remain in compliance with business and regulatory requirements.
Compliance
In addition, the platform supports 21 CFR Part 11 compliance for all TranSenda applications. The FDA defines a computerized system as not only hardware and software, but also the users, policies, and procedures that ultimately run that system. Therefore, no software package alone can fulfill the FDA's compliance requirements. However, TranSenda will work with clients to define a compliant deployment, validation, and maintenance strategy. Additionally, many of the features in Clinical Trial Process Platform will help ensure compliance including:
- The ability to control message content and automatic email notifications
- Sophisticated auditing and reporting to expose potential violations early so corrective measures can be taken to avoid penalties
- Built-in security features to control users, groups, and permissions
- Digital signature capabilities compliant with 21 CFR Part 11
- Encryption of sensitive or confidential information and email messages to meet HIPAA requirements
- Quickly incorporate new compliance regulations into clinical trial processes and revalidate only the updated components
