OUR INITIATIVES

TransCelerate’s growing portfolio of initiatives focuses on the shared vision of accelerating and enhancing the research and development of innovative new therapies. These initiatives develop practical solutions to overcome inefficiencies in clinical trials 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 while also contribute to a more rewarding clinical trial experience via better exchange of information with trial participants.

Clinical Research Awareness

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

Clinical Trial Diversification

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.

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.

Comparator Network

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.

eConsent

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.

eLabels

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.

eSource

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.

Interpretation of Pharmacovigilance Regulations

The Interpretation of Pharmacovigilance Regulations Initiative will share expertise to more efficiently and effectively meet the intent of pharmacovigilance requirements that seem ambiguous.

Investigator Registry

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.

Patient Experience & Technology

The Patient Experience & Technology (PE&T) 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.

Placebo and Standard of Care Data Sharing

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.

Quality Management System

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.

Risk Based Monitoring

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.

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 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.

Value of Safety Information Data Sources

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.

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