With recent changes in requirements and potential penalties for failing to comply, it's important for clinical research institutions to ensure compliance with disclosure requirements for ClinicalTrials.gov. For this reason, Forte has partnered with two industry-leading vendors, Virtify, Inc. and Deloitte Analytics, LLC, to deliver simplified processes for clinical trial disclosure. When integrated with the OnCore eClinical Solution, the Virtify CTRR (Clinical Trial Registration & Results) system and the Pharma CM CTR system provide a comprehensive disclosure solution.
In the wake of increased regulatory enforcement by government agencies and settlements under the Civil Monetary Penalties Law and False Claims Act, institutions conducting clinical research are under increased pressure to develop solutions for managing research billing compliance. This is why Forte Research Systems is collaborating with the experts at Aegis Compliance & Ethics Center, LLP as we enhance the research billing compliance functionality in the OnCore eClinical solution by creating a new Coverage Analysis module.
Compensating patients who volunteer to participate in clinical research studies is an important part of the clinical research process, but one that can be unduly resource intensive. For research sites, issuing checks and tracking cash payments can take substantial amounts of time and effort. For subjects, it can take weeks before their checks arrive, and once received, cashing their checks can be a hassle. For this reason, Forte has partnered with U.S. Bank AccelaPay® to develop an ePayments system for subject stipends. With seamlessly integrated systems, U.S. Bank AccelaPay® and Forte have created a more affordable and efficient solution with unprecedented ease of use for both sites and patients.
Motivated to implement continuous improvement strategies for better efficiency and quality, sponsors and CROs have collected a growing amount of data and metrics in recent years related to operational performance. Metrics can be powerful tools for implementing data-driven process improvements. One organization in particular, the Metrics Champion Consortium (MCC), is actively encouraging their use within the clinical trial industry. The MCC is a nonprofit dedicated to the development and support of performance metrics and quality tools within the clinical trial industry.
Currently, many metrics that are being collected, and the methods by which they are collected, are determined with a top-down perspective of what the sponsors and the CROs want and have little benefit for the sites. A shift away from requiring sites to enter seemingly arbitrary operational data into myriad sponsor and CRO systems and instead motivating sites to collect their own metrics for the purpose of measuring and improving their internal processes will not only improve study conduct at the sites but result in more complete and timely data for the sponsor and CROs to use. That is why Forte has joined the MCC and encouraged sites to participate in the consortium's eforts.
In order to streamline data exchange and eliminate barriers to information sharing in clinical research, standards must be set and utilized. This is why Forte has joined CDISC, a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.
Eliminating data silos and opening communication between systems improves clinical research operations across the industry. We know it takes a significant investment of time and resources to develop the domain expertise required to build great systems. For this reason, Forte has partnered with other established technology leaders with the goal of reducing data redundancy and the potential for data entry errors for the benefit of our common customers.
The OnCore SDK currently supports the exchange of protocol information and reviews with eIRB systems. Support for the exchange of SAEs, deviations, outside safety reports, and IRB-specific documents such as investigational brochures and consent forms is under development in collaboration with Forte's partners.
For more information on partnering with Forte Research Systems, please contact: