OUR INITIATIVES

This initiative aims to develop best practices and guidance around the application of interrogative methods towards various safety data sources.

The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.

The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.

Clinical Research Access & Information Exchange seeks to provide a better window into information about clinical research and trial options and to contribute to a more rewarding clinical trial experience via better exchange of information with trial participants.

Clinical Research Awareness seeks to educate the public about clinical research and encourage conversations about clinical trials between patients and their health care providers.

The Clinical Trial Diversification Initiative has achieved its goal of developing better practice materials for site and sponsors to improve engagement and recruitment of minority patient populations.

The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language to improve accuracy in data recordation and speed study start up.

The Common Clinical Serious Adverse Events (SAE) Fields Initiative intends to conduct a feasibility assessment, develop best practices relating to identifying the most critical SAE fields.

This initiative will develop a Common SAP Template, which aims to provide a common layout and model content for SAP documentation, and will link directly to TransCelerate’s Common Protocol Template (CPT).

TransCelerate’s Comparator Network establishes a reliable, rapid sourcing of quality products for use in clinical trials for participating Member Companies to avoid counterfeiting and avoid delays in study start-up.

This initiative aims to develop a framework / toolkit for Sponsors to use to increase the population of people with sufficient skills to serve on a DMC.

This initiative aims to move the drug development process from a current state of manual, study start-up asset creation (i.e. Case Report Forms, Procedure Manuals, Statistical Analysis Plans, and Schedule of Activities) to a future state of fully-automated, dynamic, study start-up readiness via an open-sourced, vendor-agnostic technical solution that will reduce cycle times and improve data quality for sponsors, third-party providers, sites and regulators.

The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to provide insight into patients’ understanding, increase regulatory compliance, and reduce quality risks.

The eLabels Initiative will support TransCelerate Member Companies in establishing an innovative information channel: Electronic Labels (eLabels). This initiative will work to enhance label utility for patients.

The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.

The Intelligent Automation Initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes.

The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of ambiguous regulatory requirements and guidances in both the pharmacovigilance and clinical areas.

The Investigator Registry initiative enhances TransCelerate’s Shared Investigator Platform, and accelerates identification and recruitment of qualified investigators, which will avoid duplication of standard site qualification and the creation of investigator documentation, and thereby reducing cost and trial length.

The Modernization of Data Analytics for Clinical Development Initiative aims to analyze methods for considering and validating novel statistical computing platforms to propose to Health Authorities and better enable them to support these platforms.

The Pediatric Efficiencies Initiative thoroughly assessed potential solutions that would lead to faster access to new drugs for pediatric patients. Rather than continue as a standalone initiative, we will transition the focal points of pediatric populations across the broader TransCelerate portfolio, where appropriate.

The Placebo and Standard of Care (PSoC) Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.

The Protocol Deviations Initiative has developed a toolkit to support clarity in definition and a holistic approach to the management of protocol deviations. Click before to access these materials.

Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.

The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences.

The Shared Investigator Platform (SIP) will facilitate interaction between investigators and multiple clinical trial sponsors, enabling study planning, study start-up and study conduct activities while reducing the administrative burden on site staff.

The Site Qualification and Training or ‘SQT’ Initiative collaborates with TransCelerate Member Companies, investigator sites, CROs and health authorities to achieve the goal of enhancing and simplifying clinical trial SQT processes and to reduce administrative burden on sites.

The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for single high value valid cases and develop a proposed method for aggregate reporting of lower value cases.