TransCelerate’s growing portfolio of Initiatives focuses on the shared vision of accelerating and enhancing the research and development of innovative new therapies. Our Initiatives develop practical solutions to overcome inefficiencies in clinical research and are drawn from the combined expertise of our members and industry collaborators.
Clinical Data Standards
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.
Clinical Data Transparency
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
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.
Common Protocol Template
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.
Common Serious Adverse Events (SAE) Fields
The Common Serious Adverse Events (SAE) Fields Initiative intends to conduct a feasibility assessment, develop best practices relating to identifying the most critical SAE fields, and work with an industry standard setting organization to promulgate standards in this area, all with the intent of increasing the quality of what is reported and creating efficiencies for sites, CROs and regulators.
Common Statistical Analysis Plan (SAP) Template
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.
Data Monitoring Committee
This initiative aims to facilitate development of a means of expanding clinical trial sponsors’ access to a broader pool of candidates when convening DMCs, and to provide an approach for newly identified individuals to gain experience through mentoring relationships.
Digital Data Flow
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 increase insight into patients’ understanding, increase regulatory compliance, and reduce quality risks.
Interpretation of Guidances & Regulations
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.
Modernization of Data Analytics for Clinical Development
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 Patient Technology (PT) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce patient burden in clinical trials.
Pediatric Trial Efficiencies
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 Protocol Deviations Initiative has developed a toolkit to reduce confusion in definition and a holistic approach to the management of protocol deviations. These improvements should ultimately lead to improved patient safety, reliability of study data, human subject’s protections and data quality.
Shared Investigator Platform
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.
Site Qualification and Training (SQT)
The 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.