THOUGHT LEADERSHIP

Throughout the 17 years that PROMETRIKA has offered Clinical Operations services, our goals have been to streamline and maximize efficiency in clinical trials and provide trial management transparency to our sponsors. We have steadily enhanced and integrated our trial data collection and management systems to achieve a fully integrated platform that will provide seamless coordination of EDC, CTMS, and eTMF data.

As a CDISC Platinum Member, PROMETRIKA has the opportunity to sit on the CDISC Advisory Council (CAC), which plays an important role in shaping CDISC’s development and direction. Platinum Member representatives serve on the CAC, contributing industry expertise and sharing real-world implementation experiences. The CAC represents a cross-section of organizations within the pharma industry; thus, making them a part of the review process for assessing and revising standards. Collectively, the CAC provides the CDISC Executive Team with recommendations that further the CAC mission of “unifying the voices of membership to influence and support CDISC goals.”

The accurate analysis and reporting of data is necessary to the evaluation of new treatments for human diseases. Regulatory authorities must weigh the risks with the benefits of treatments in their approval decisions. Often, regulators will ask sponsors to provide information about the analyses, such as the datasets and data selection criteria used to generate the results. The Clinical Data Interchange Standards Consortium (CDISC) has described their newest initiative to standardize analysis results in the form of tables, listings, and figures (TLF) and reporting of data across the industry.

Drug Safety & Pharmacovigilance professionals have long awaited consistency in the manner in which the US Food and Drug Administration (FDA) accepts Individual Case Safety Report (ICSR) submissions. For years, the industry has navigated different submission procedures for FDA compared with other regions, as well as differences between Investigational New Drug (IND) reporting and post-marketing pharmacovigilance reporting. The FDA has been working towards harmonization of ICSR submissions and the final guidance is here! FDA will require that both premarket and post-market safety reports be submitted electronically in the ICH E2B(R3) format, the format that is currently the standard in the EU. Let us explore the current FDA practices, the need for updated processes, timelines for implementation, and what pharmacovigilance professionals need to do to prepare for the change.

Current European law prohibits businesses from sending personal information about European citizens to companies in the United States (US) without specific contractual obligations to protect the privacy of the information.  However, the current Data Privacy Framework (DPF) allows US companies that are “Certified” under the Framework to import and process personal data of European citizens without these contractual requirements.