TransCelerate BioPharma Incorporated

In 2023, Transcelerate delivered the following accomplishments:transcelerate delivered 47 pragmatic solutions and adoption tools, bringing the total number since the inception of the organization to 570+. See schedule o for additional program service accomplishments.transcelerate partnered with the association of clinical research organizations (acro) to work on co-developing a series of solutions to aid stakeholders in navigating good clinical practice (gcp) guidelines.the interpretation of clinical guidances & regulations initiative released a paper "the renovation of good clinical practice: a framework for key components of ich e8," to enhance the understanding of specific topics detailed in ich e8 including qbd, ctq, fit for purpose, and stakeholder engagement. Biocelerate, a limited liability company classified as a disregarded entity in which Transcelerate is the sole member("biocelerate"), conducted an initiative to develop common templates for nonclinical studies, which wrapped up development at the end of 2023 and is now complete. Solutions delivered included a nonclinical common protocol template, a nonclinical common study report template, and supporting implementation materials.biocelerate established the biocelerate collaboration forum. This forum convenes stakeholders in preclinical research to engage on challenges, opportunities, and possible solutions. Two events were held in 2023 bringing together 17 organizations representing sponsors, cros, and health authorities. The privacy methodology for data sharing initiative created the methodology for data sharing toolkit to enhance data utility while protecting patient privacy . A privacy methodology informational resource video as well as a privacy methodology informational resource were also delivered. A transparency checklist was created as a template of key information, which allows a data provider to describe the data modifications/derivations performed. This information helps facilitate use of the data by data recipients.the digital data flow initiative (ddf) hosted a series of global workshops to identify learnings and garner feedback from stakeholders. The initiative work with a standard-setting organization, the clinical data interchange standards consortium (cdisc), to develop the cdisc unified study definitions model (usdm) v2.0. The initiative also created the study definitions repository (sdr) v2.0.1 reference implementation & associated source code, and a series of persona toolkits for clinical data managers, protocol medical writers, and information technology leadership and technical expert roles. The launch of the digital data flow technology architecture scenarios tool provides a set of scenarios for the technical implementation of the usdm.transcelerate strategically combined the efforts of its ddf and cc&r initiatives and our engagement in the hl7 vulcan fhir accelerator (hl7 vulcan) --which builds upon our previous esource workto modernize solutions on the evolving regulatory landscape. In 2023, hl7 vulcan launched a new project to collaborate with cdisc and ich m11 clinical cesharp. The real world data (rwd) audit readiness initiative published "assuring audit and inspection readinessconsiderations for the use of rwd and rwe in regulatory decision-making." A real world data health authority engagement awareness toolkit was developed to delineate a reliable, streamlined, and scalable approach for interactions with health authorities concerning the use of rwd for decision-making.the participant data return initiative (pdr) created an individual participant data return (ipdr) package that provides general considerations to enable data return to clinical study participants.the patient technology initiative updated the patient technology regulatory landscape tool that provides an overview of regulatory requirements related to patient technology and its use in clinical trials.the personalized clinical trials framework created a set of practical considerations across 14 potential opportunities to support the r&d ecosystem in offering options that help integrate clinical trial requirements more seamlessly into the lives of trial participants. The patient experience initiative (pe) created a gratitude toolkit along with an infographic that is designed to enable study sponsors and sites to show appreciation to clinical study participants. A set of practical considerations titled "personalized clinical trials framework" was created to support understanding and evaluating options that enable a more personalized experience for clinical trial participants across diverse populations. Transcelerate supported the accelerating clinical trials in the european union (act eu) working group by providing collective comments and recommendations to its "recommendation paper on decentralised elements in clinical trials." The diversity of participants in clinical trials initiative created the fda diversity plan early insights & considerations, an aggregated collection of insights and considerations gathered from member company interviews. Transcelerate's diversity initiative began work on modifying its earlier work to creat the u.s. regulatory landscape: diversity in clinical trials v2.0, which will reflect the evolution in the regulatory landscape since the prior version was released. The rapid signal assessment using real world data initiative (rsa rwd) released the "safety signal assessment." The initiative also developed a framework for rapid signal assessment using real-world data which provides an end-to-end high-level process map on using rwd as an option to conduct safety signal assessments more rapidly.the interpretation of pharmacovigilance guidances & regulations initiative's (igr-pv) team created essential tools to identify drug development opportunities for pregnant and breastfeeding patients and released a peer-reviewed paper "call to action: harmonisation of pharmacovigilance regulations for post-marketing pregnancy and breastfeeding safety studies." They also created an improving safety & efficacy of medicines for pregnant & breastfeeding people infographic. The pharmacovigilance agreements optimization initiative (pvao) team delivered a paper "negotiating your way through the vigilance agreement mazeis there a better way?" Supplemental materials were created to provide additional considerations. The initiative delivered a peer-reviewed article "pharmacovigilance agreements: negotiating safety data exchange timelines: to agree to disagree? That is the question." The intelligent automation opportunities in pharmacovigilance initiative (iao) released a peer-reviewed article, "individual case safety report replication: an analysis of case reporting transmission networks," that reports an analysis performed to provide a first-time quantification of the amount of icsr replication taking place. An artificial intelligence-based validation case study themes was created to provide themes from use cases focused on early adopters' experiences applying ai to pv applications. And "signal management intelligent automation opportunities for signal detection" was created to identify how a sampling of companies are currently using intelligent automations.