You have questions, we have answers

Typically, our clients will utilize the Complion platform for all new trials starting after a given go-live date. Conversion of existing and/or archived trials typically requires a significant amount of scanning, file indexing and uploading into the platform. We can provide tools to help you facilitate this process and/or services to convert the trials for you.

The Complion platform has been developed based on best practices in collaboration with leading research sites for the specific intended use of creating and maintaining documents and workflows. The Complion team consists of research certified experts as well as software developers with expertise in document and workflow management systems. Because of this experience and focus, the Complion platform does what a CTMS cannot do – create and maintain audit-ready, Part 11 complaint electronic records and signatures with comprehensive and easy-to-use features on any device. The Complion platform augments and is compatible with existing systems that manage institutional review boards (IRB), trial databases, patient registries, billing, coverage analysis, Electronic Data Capture (EDC), biospecimens and/or staff tracking.

While shared drives are readily available and may even be regularly backed up by your research site’s IT team, they lack key software features required by the FDA in an entirely electronic document system, including: safeguards for deletion/misconduct, eSignature capabilities, audit trails, user access controls, encryption, reports and more. Furthermore, a research site that develops these features in their shared drive is then also required to perform user validation, training, software development and server management following documented policies. Complion offers all of the above.

Shared drives are not Part 11 compliant and therefore require the research site to maintain redundant paper binders in order to be compliant. The FDA has and is continuing to issue inspection observations to research sites for using shared drives. Learn more about Part 11 compliance and Complion’s solution.

In accordance with ICH GCP, Complion’s platform allows the research site to own and control documents and records from startup through long-term archiving, which are separate from the sponsor’s own records. The Complion platform was built by clinical researchers, for clinical researchers, for the specific intended use of managing electronic documents and records in 100% compliance with all applicable rules and regulations.

There are specific FDA requirements for research sites that maintain electronic records and signatures. Therefore, using a sponsor-provided portal or electronic Investigator Site Files (eISF) is not compliant and will require your site to keep redundant paper binders. The FDA has and is continuing to issue inspection observations to research sites not in Part 11 compliance. Learn more about Part 11 compliance.

The Complion platform serves as the research site’s record as compared to the sponsor’s. Furthermore, it is compatible with sponsor-provided portals and therefore augments their capabilities. Typically, research sites on the Complion platform will receive various documents from the sponsor via the portal and then drag-and-drop those files into the Complion platform. Should the sponsor need to access their documents, the research site can provide access for the specific trial(s) and/or export appropriate audit-ready PDF documents for upload into the sponsor portal.

Please email webinars@complion.com and make a request to share your experiences, best practices and resources with the community. We look forward to hearing from you!

No. You can register up until the last second before the live webinar, however it’s a good idea to register early to guarantee your spot since space is limited.

It’s FREE …seriously. Even if you’re not a customer, we want to help by fostering a community that shares best practices, addresses challenges and supports one another. That’s why we have a robust library of resources and educational webinars to help your site achieve success. See our Resource Library.

The Complion platform streamlines the flow of information, reduces redundancy and protects an organization’s investment in existing systems through integration. As mentioned above, Complion enables single sign-on integrations with many other commercially available and internal IT systems, including: LDAP, SAML and ADFS. The Complion platform is standards-based with Application Programming Interfaces (APIs) that are designed to connect more easily with other systems, such as electronic Institutional Review Board (eIRB), Clinical Trial Management Systems (CTMS) and Electronic Medical Records (EMR).

We typically release new updates of software that require re-validation twice a year. The validation process is described elsewhere on this page. For every software update, the entire comprehensive re-validation process can be performed in a single meeting for every research site. This re-validation process may typically take thirty minutes for each new release, however we can take more time to meet your needs or expedite the process to fit your time constraints. Typically, for research sites deciding to perform this process on their own, this would require months of time and tremendous technical experience. Research sites are not required to validate or re-validate the platform on a per trial basis, but rather once at a platform level for all trials.

• Complion meets industry best practices for technical controls and security following documented and audited SOPs. All documents can be digitally archived indefinitely or following your research site’s record retention policy. Site documents and data are backed up in realtime to mitigate data loss in the event of a failover.
• Our data centers are compliant with FDA regulations. Please Contact Us if you would like to learn more about how we comply with FDA regulations.
• The research site owns all information on the Complion platform and we will keep your important information highly confidential and hold our employees to the highest ethical standards through documented training to ensure that we only access your information for support purposes. We maintain our own SOPs for hosting, software development and validation, and HIPAA security and privacy, including: software development, software developer validation, disaster recovery, backups, Complion staff training, cloud server installation, cloud server validation and internal audits.

Complion follows a trusted 21 CFR Part 11 validation process developed in collaboration with leading research sites to ensure compliance following industry best practices. Complion works with our clients to separately validate the platform prior to implementation and with any new software updates, and can complete this process in a single meeting with staff at the research site who have no formal technical knowledge of Part 11. First, Complion will provide an educational overview on Part 11 as well as industry best practices for validation. Next, we provide a validation protocol that defines Part 11 requirements, platform design specifications and end user test cases. We can also customize such documentation for you to support an existing IT validation process. Finally, we facilitate platform testing following the validation protocol and produce a validation record. This entire process can be performed in a single meeting for every research site prior to implementation and with each validated software update. This process may typically take one hour prior to implementation and thirty minutes with each new release, however we can take more time to meet your needs or expedite the process to fit your time constraints. Typically, for research sites deciding to perform this process on their own, this would require months of time and tremendous technical experience. Research sites are not required to validate or re-validate the platform on a per trial basis, but rather once at a platform level for all trials.

The research site identifies admin users who can control per-trial, role-based access to the Complion platform. When added to a trial, monitors new to the platform will receive an email in their existing email account with a link to register on the platform. Monitors that are already registered on the platform will simply receive an email notification and can access the new trial(s) on their next login utilizing their existing password for all research sites. Monitors have view-only access on the platform, but do have access to various search, export and communication tools to foster efficiency and compliance for both the research site and monitor. Additionally, monitors have access to all support and customer community content and training. Monitor access can be provided throughout the lifetime of the trial to greatly reduce the amount of correspondence with self-service access, or can be provided for a pre-defined period of time. In both cases, admin users can remove monitors from specific or all trials at your research site at any time.

No. Monitors register once on the platform and can access designated trials across all of their sites with integrated training and support. In fact, most sponsors and CROs currently have active monitors on the Complion platform.