As part of the Modernizing Clinical Trial Conduct (MCTC) initiative, a suite of robust solutions has been created to support a more patient-centric clinical trial ecosystem.
These solutions leverage TransCelerate’s mission of cross-industry collaboration to improve clinical trial processes for patients, sites, and sponsors, incorporating lessons learned during and beyond the COVID-19 pandemic. Solutions span trial planning through to trial closeout and include tools to support sponsors facilitate the implementation of decentralized methods, resources to enable the collection of patient and site feedback to inform decentralized methods, and surveys compiling data on Member Company experiences with the adoption of said decentralized methods.
Navigate the suite of solutions by clicking on each step in the clinical trial process below.
Trial Planning
Solutions and resources to support trial planning – including considerations for patients, sites and the implementation of decentralized methods.
Operational Complexity Assessment Tool (O-CAT) (2021)
This interactive tool assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation. Assessing operational complexity before implementing a solution will help a sponsor to identify areas that may increase the complexity of implementation and give the sponsor some ability to develop strategies to reduce or mitigate the complexity.
Process Frameworks (2021)
These frameworks outline various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions, also known as decentralized methods.
Trial Start-Up
Solutions and additional resources to support clinical trial start-up to be made available soon.
Trial Conduct & Closeout
Solutions and resources to support trial conduct and closeout.
A paper that describes learnings from a survey deployed in 2023 among TransCelerate member companies to understand collective experience deploying Modern Clinical Trial Solutions (also known as DCT elements) beyond the COVID-19 pandemic. Details include the associated challenges and lessons learned, and the factors that made DCT implementation successful.
Maturity Survey Detailed Report (2021)
To better understand the collective experience of TransCelerate members deploying select modern solutions, a maturity survey was conducted. This document presents the aggregated, blinded findings from this survey.
Continuity Solution Case Studies (2020)
Presentation of five case studies of continuity solutions implemented during the COVID-19 pandemic. Case study information includes a description of the continuity solution, different to traditional models, challenges and success factors.
Beyond COVID-19: Modernizing Clinical Trial Conduct (2020)
A paper highlighting the continuity solutions implemented during the pandemic.
Additional Resources
Other resources, and thought leadership, to further support the modernization of clinical trial conduct.
Clinical Trials 2031 and Beyond Report (2022)
Report that utilizes a scenario planning exercise to explore the potential drivers influencing the future of clinical trials. Building on input from diverse thought leaders in the healthcare ecosystem, it further organizes the identified drivers into a matrix, which can be utilized to explore how combinations of the drivers might impact clinical trials in the future. To aid the thought process, the MCTC team has identified four potential future scenarios of clinical trials and outlined the characteristics of each scenario.
Pre-COVID-19 RBM SDV/SDR Pandemic Practices (2021)
A summary of key findings from a voluntary 2020 survey conducted in TransCelerate Member companies pre-COVID, regarding their Risk Based Monitoring (RBM) practices related to Source Data Verification (SDV) and Source Data Review (SDR).
MCTC Workshop Findings (2020)
Write up of workshop findings from sessions held in 2020 to further understand the root cause of why industry hasn’t already moved towards modernized clinical trial conduct, define the successful use of modernized clinical trials solutions and associated requirements, and explore how to transition to using these solutions at-scale and the scenarios where they are most appropriate.